Trial Outcomes & Findings for PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy (NCT NCT03132636)

Last Updated: 2025-04-08

Results Overview

ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 assessed as per ICR assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

138 participants

Primary outcome timeframe

Up to 1422 days (approximately 46 months)

Results posted on

2025-04-08

Participant Flow

138 of the 170 screened participants, were enrolled \& treated. Eligible participants were enrolled into 2 groups. Group 1: participants with metastatic Basal Cell Carcinoma (mBCC). Group 2: participants with unresectable locally advanced BCC (laBCC) who experienced progression of disease on Hedgehog inhibitor (HHI) therapy, or response no better than stable disease for at least 9 months or were intolerant of prior HHI therapy.

Participant milestones

Participant milestones
Measure	Group 1: Metastatic BCC (mBCC) Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Study STARTED	54	84
Overall Study Completed Treatment	11	28
Overall Study COMPLETED	6	19
Overall Study NOT COMPLETED	48	65

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Metastatic BCC (mBCC) Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Study Adverse Event	1	2
Overall Study Death	4	7
Overall Study Lost to Follow-up	3	2
Overall Study Non compliance with protocol by participant	1	1
Overall Study Subject decision	1	9
Overall Study Sponsor decision	0	1
Overall Study Physician Decision	1	0
Overall Study Progressive disease	33	36
Overall Study Withdrawal of consent	2	5
Overall Study Did not re-consent	1	0
Overall Study Lost insurance coverage	1	0
Overall Study Related to radiological outcomes	0	1
Overall Study Unable to come to site for continued visits	0	1

Baseline Characteristics

PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.	Total n=138 Participants Total of all reporting groups
Age, Continuous	63.8 Years STANDARD_DEVIATION 11.09 • n=93 Participants	69.1 Years STANDARD_DEVIATION 12.84 • n=4 Participants	67.0 Years STANDARD_DEVIATION 12.42 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	28 Participants n=4 Participants	44 Participants n=27 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	56 Participants n=4 Participants	94 Participants n=27 Participants
Race/Ethnicity, Customized Race : White	47 Participants n=93 Participants	57 Participants n=4 Participants	104 Participants n=27 Participants
Race/Ethnicity, Customized Race : Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Race : Missing	6 Participants n=93 Participants	27 Participants n=4 Participants	33 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity : Not Hispanic or Latino	46 Participants n=93 Participants	56 Participants n=4 Participants	102 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity : Hispanic or Latino	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Ethnicity : Missing	6 Participants n=93 Participants	27 Participants n=4 Participants	33 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 1422 days (approximately 46 months)

Population: Full analysis set (FAS) (included all enrolled participants for each group who passed screening and were deemed to be eligible for this study)

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Objective Response Rate (ORR) as Assessed by Independent Central Review (ICR)	22.2 Percentage of Participants Interval 12.0 to 35.6	32.1 Percentage of Participants Interval 22.4 to 43.2

SECONDARY outcome

Timeframe: Up to 1422 days (approximately 46 months)

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.

ORR was defined as percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST v1.1 per Investigator assessment. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm) (\< 1 centimeter \[cm\]). PR: At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. ORR was determined by Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Objective Response Rate (ORR) Per Investigator Assessment	25.9 Percentage of Participants Interval 15.0 to 39.7	36.9 Percentage of Participants Interval 26.6 to 48.1

SECONDARY outcome

Timeframe: Up to 48 months

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. Here, "Overall number of participants analyzed" signifies those participants with confirmed CR or PR.

DOR per ICR was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=12 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=27 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Duration of Response (DOR) as Assessed by ICR	NA Months Interval 9.8 to Because 50.0% of participants were censored and there was a greater than 50% chance of surviving at follow-up, the median survival and upper bounds of the 95% confidence interval could not be estimated.	NA Months Interval 15.5 to Because 70.4% of participants were censored and there was a greater than 50% chance of surviving at follow-up, the median survival and upper bounds of the 95% confidence interval could not be estimated.

SECONDARY outcome

Timeframe: Up to 48 months

DOR per investigator assessment was determined for participants with best overall response of CR or PR. DOR was measured from the time measurement criteria are first met for CR/PR (whichever was first recorded) until the first date of recurrent or progressive disease (PD) (photographic or radiographic), or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). DOR was determined by Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=14 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=31 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Duration of Response (DOR) Per Investigator Assessment	NA Months Interval 9.8 to Data could not be estimated due to higher number (64.3%) of censored participants	19.6 Months Interval 16.7 to Data could not be estimated due to higher number (54.8%) of censored participants

SECONDARY outcome

Timeframe: Up to 48 months

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.

CR rate was determined by the percentage of participants with best overall response of CR. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). CR rate 95% confidence interval determined by Clopper-Pearson exact confidence interval.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Complete Response (CR) Rate as Assessed by ICR	3.7 Percentage of Participants Interval 0.5 to 12.7	8.3 Percentage of Participants Interval 3.4 to 16.4

SECONDARY outcome

Timeframe: Up to 48 months

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Complete Response (CR) Rate Per Investigator Assessment	3.7 Percentage of Participants Interval 0.5 to 12.7	8.3 Percentage of Participants Interval 3.4 to 16.4

SECONDARY outcome

Timeframe: Up to 60 months

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.

PFS was defined as the time from start of treatment until the first date of recurrent or PD (photographic or radiographic), or death due to any cause, whichever occurred first, was determined by IRC. PD: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). PFS was determined by Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Progression Free Survival (PFS) as Assessed by ICR	10.1 Months Interval 4.2 to 15.9	16.5 Months Interval 8.6 to 21.8

SECONDARY outcome

Timeframe: Up to 60 months

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Progression Free Survival (PFS) Per Investigator Assessment	6.6 Months Interval 4.2 to 8.3	18.1 Months Interval 10.4 to 21.3

SECONDARY outcome

Timeframe: Up to 60 months

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study.

OS was measured as time from the start of treatment until death due to any cause. Participants who did not die were censored at the last date that participant was documented to be alive. OS was calculated based on Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Overall Survival (OS)	49.9 Months Interval 28.4 to Because 59.3% of participants were censored and there was a greater than 50% chance of surviving at follow-up, the upper bound of the 95% confidence interval could not be estimated.	NA Months Because 75.0% of participants were censored and there was a greater than 50% chance of surviving at follow-up, the median overall survival and lower and upper bounds of the 95% confidence interval could not be estimated.

SECONDARY outcome

Timeframe: Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks])

Population: The FAS included all enrolled participants for each group who passed screening and were deemed to be eligible for this study. "Number analyzed" signifies those participants who were evaluable at specific time points.

The EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall QoL in cancer participants. It consists of 15 domains: 1 Global Health Status (GHS)/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a higher score indicates higher ("better") quality of life/functioning and a positive change from baseline indicates improvement. For the symptom scales/items, a higher score indicates a higher ("worse") level of symptoms/problems, and a negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 2 Day 1	-4.88 Score on a Scale Standard Deviation 14.274	-1.55 Score on a Scale Standard Deviation 12.101
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 6 Day 1	-1.75 Score on a Scale Standard Deviation 17.476	-2.56 Score on a Scale Standard Deviation 29.004
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 7 Day 1	-5.13 Score on a Scale Standard Deviation 12.518	-1.01 Score on a Scale Standard Deviation 30.601
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 8 Day 1	-3.33 Score on a Scale Standard Deviation 10.541	-2.08 Score on a Scale Standard Deviation 31.609
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 9 Day 1	-3.03 Score on a Scale Standard Deviation 17.979	1.19 Score on a Scale Standard Deviation 30.741
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 2 Day 1	1.55 Score on a Scale Standard Deviation 19.181	2.25 Score on a Scale Standard Deviation 21.603
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 3 Day 1	0.00 Score on a Scale Standard Deviation 21.822	1.06 Score on a Scale Standard Deviation 20.712
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 4 Day 1	-2.56 Score on a Scale Standard Deviation 18.674	1.23 Score on a Scale Standard Deviation 21.440
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 3 Day 1	-1.78 Score on a Scale Standard Deviation 13.481	-0.56 Score on a Scale Standard Deviation 15.947
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 4 Day 1	-6.60 Score on a Scale Standard Deviation 12.828	-3.79 Score on a Scale Standard Deviation 17.814
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 5 Day 1	1.08 Score on a Scale Standard Deviation 10.033	-2.86 Score on a Scale Standard Deviation 17.063
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 6 Day 1	-1.67 Score on a Scale Standard Deviation 9.734	0.33 Score on a Scale Standard Deviation 12.073
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 7 Day 1	-0.38 Score on a Scale Standard Deviation 11.142	-0.20 Score on a Scale Standard Deviation 15.410
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 8 Day 1	-1.33 Score on a Scale Standard Deviation 12.090	-3.03 Score on a Scale Standard Deviation 13.549
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Physical Functioning: Change at Cycle 9 Day 1	-2.27 Score on a Scale Standard Deviation 8.765	-5.06 Score on a Scale Standard Deviation 20.444
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 2 Day 1	-2.71 Score on a Scale Standard Deviation 27.442	-3.11 Score on a Scale Standard Deviation 20.264
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 3 Day 1	5.17 Score on a Scale Standard Deviation 27.854	-4.87 Score on a Scale Standard Deviation 25.297
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 6 Day 1	0.00 Score on a Scale Standard Deviation 15.713	-1.67 Score on a Scale Standard Deviation 18.413
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 7 Day 1	5.13 Score on a Scale Standard Deviation 18.490	4.04 Score on a Scale Standard Deviation 13.838
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 4 Day 1	-3.21 Score on a Scale Standard Deviation 25.394	-6.06 Score on a Scale Standard Deviation 26.326
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 5 Day 1	5.00 Score on a Scale Standard Deviation 22.361	-5.33 Score on a Scale Standard Deviation 26.393
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 6 Day 1	6.14 Score on a Scale Standard Deviation 21.667	-3.33 Score on a Scale Standard Deviation 16.963
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 8 Day 1	13.33 Score on a Scale Standard Deviation 23.307	-2.02 Score on a Scale Standard Deviation 16.540
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 7 Day 1	12.82 Score on a Scale Standard Deviation 24.677	-7.07 Score on a Scale Standard Deviation 16.682
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 8 Day 1	15.00 Score on a Scale Standard Deviation 25.398	-4.04 Score on a Scale Standard Deviation 19.557
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 9 Day 1	0.00 Score on a Scale Standard Deviation 14.907	1.15 Score on a Scale Standard Deviation 22.683
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 2 Day 1	3.88 Score on a Scale Standard Deviation 14.924	0.45 Score on a Scale Standard Deviation 24.360
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Role Functioning: Change at Cycle 9 Day 1	9.09 Score on a Scale Standard Deviation 22.808	-9.77 Score on a Scale Standard Deviation 30.052
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 2 Day 1	3.17 Score on a Scale Standard Deviation 19.638	1.95 Score on a Scale Standard Deviation 20.483
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 3 Day 1	1.15 Score on a Scale Standard Deviation 18.730	1.56 Score on a Scale Standard Deviation 18.538
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 4 Day 1	3.53 Score on a Scale Standard Deviation 22.007	1.39 Score on a Scale Standard Deviation 21.277
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 3 Day 1	1.15 Score on a Scale Standard Deviation 14.037	-1.04 Score on a Scale Standard Deviation 20.547
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 4 Day 1	3.85 Score on a Scale Standard Deviation 23.715	-1.85 Score on a Scale Standard Deviation 19.870
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 5 Day 1	5.83 Score on a Scale Standard Deviation 24.046	-4.59 Score on a Scale Standard Deviation 19.622
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 6 Day 1	7.02 Score on a Scale Standard Deviation 20.650	1.04 Score on a Scale Standard Deviation 19.809
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 7 Day 1	3.85 Score on a Scale Standard Deviation 18.199	-4.63 Score on a Scale Standard Deviation 19.576
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 8 Day 1	16.67 Score on a Scale Standard Deviation 25.000	3.11 Score on a Scale Standard Deviation 19.810
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Emotional Functioning: Change at Cycle 9 Day 1	5.30 Score on a Scale Standard Deviation 17.189	2.11 Score on a Scale Standard Deviation 17.246
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 2 Day 1	0.78 Score on a Scale Standard Deviation 13.586	-2.48 Score on a Scale Standard Deviation 26.985
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 5 Day 1	6.67 Score on a Scale Standard Deviation 20.520	-0.68 Score on a Scale Standard Deviation 23.064
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 3 Day 1	-1.72 Score on a Scale Standard Deviation 16.871	-4.17 Score on a Scale Standard Deviation 23.382
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 4 Day 1	-0.64 Score on a Scale Standard Deviation 15.261	-4.94 Score on a Scale Standard Deviation 21.385
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 5 Day 1	-4.17 Score on a Scale Standard Deviation 14.178	-6.46 Score on a Scale Standard Deviation 25.188
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 6 Day 1	-0.88 Score on a Scale Standard Deviation 12.998	-1.25 Score on a Scale Standard Deviation 19.017
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 7 Day 1	-2.56 Score on a Scale Standard Deviation 11.479	-5.56 Score on a Scale Standard Deviation 18.942
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 8 Day 1	-6.06 Score on a Scale Standard Deviation 11.237	1.52 Score on a Scale Standard Deviation 17.362
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Cognitive Functioning: Change at Cycle 9 Day 1	-10.61 Score on a Scale Standard Deviation 25.025	-2.30 Score on a Scale Standard Deviation 23.873
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 2 Day 1	0.39 Score on a Scale Standard Deviation 19.412	4.50 Score on a Scale Standard Deviation 21.422
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 3 Day 1	3.45 Score on a Scale Standard Deviation 16.891	0.78 Score on a Scale Standard Deviation 21.088
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 4 Day 1	3.85 Score on a Scale Standard Deviation 24.179	1.85 Score on a Scale Standard Deviation 23.272
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 5 Day 1	3.33 Score on a Scale Standard Deviation 22.685	0.34 Score on a Scale Standard Deviation 23.445
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 6 Day 1	10.53 Score on a Scale Standard Deviation 16.860	0.00 Score on a Scale Standard Deviation 24.749
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 6 Day 1	3.51 Score on a Scale Standard Deviation 18.904	-1.67 Score on a Scale Standard Deviation 18.413
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 7 Day 1	12.82 Score on a Scale Standard Deviation 22.724	0.00 Score on a Scale Standard Deviation 18.162
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 8 Day 1	10.61 Score on a Scale Standard Deviation 15.407	2.02 Score on a Scale Standard Deviation 23.848
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 7 Day 1	0.00 Score on a Scale Standard Deviation 13.608	1.01 Score on a Scale Standard Deviation 19.516
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Social Functioning: Change at Cycle 9 Day 1	9.09 Score on a Scale Standard Deviation 13.670	-2.30 Score on a Scale Standard Deviation 27.359
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 2 Day 1	5.17 Score on a Scale Standard Deviation 22.919	6.44 Score on a Scale Standard Deviation 24.542
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 3 Day 1	1.92 Score on a Scale Standard Deviation 18.322	6.58 Score on a Scale Standard Deviation 24.901
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 8 Day 1	0.00 Score on a Scale Standard Deviation 14.907	-1.01 Score on a Scale Standard Deviation 19.516
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Diarhoea: Change at Cycle 9 Day 1	0.00 Score on a Scale Standard Deviation 14.907	-2.30 Score on a Scale Standard Deviation 21.696
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 2 Day 1	-3.10 Score on a Scale Standard Deviation 17.539	-3.15 Score on a Scale Standard Deviation 25.385
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 4 Day 1	-2.56 Score on a Scale Standard Deviation 21.154	7.58 Score on a Scale Standard Deviation 25.912
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 5 Day 1	-5.56 Score on a Scale Standard Deviation 24.048	9.67 Score on a Scale Standard Deviation 23.404
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 3 Day 1	0.00 Score on a Scale Standard Deviation 18.144	-4.23 Score on a Scale Standard Deviation 24.313
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 4 Day 1	-5.13 Score on a Scale Standard Deviation 22.494	-4.94 Score on a Scale Standard Deviation 23.710
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 6 Day 1	-5.85 Score on a Scale Standard Deviation 19.376	7.78 Score on a Scale Standard Deviation 17.649
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 8 Day 1	-7.78 Score on a Scale Standard Deviation 24.595	9.09 Score on a Scale Standard Deviation 19.534
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 9 Day 1	-1.01 Score on a Scale Standard Deviation 16.067	12.64 Score on a Scale Standard Deviation 20.080
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 5 Day 1	0.00 Score on a Scale Standard Deviation 18.732	-6.80 Score on a Scale Standard Deviation 22.546
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 2 Day 1	-0.78 Score on a Scale Standard Deviation 8.095	0.22 Score on a Scale Standard Deviation 12.703
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 3 Day 1	0.00 Score on a Scale Standard Deviation 13.363	-1.79 Score on a Scale Standard Deviation 12.884
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 4 Day 1	0.00 Score on a Scale Standard Deviation 16.330	0.30 Score on a Scale Standard Deviation 13.414
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 5 Day 1	0.83 Score on a Scale Standard Deviation 10.080	1.00 Score on a Scale Standard Deviation 13.640
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 6 Day 1	-0.88 Score on a Scale Standard Deviation 3.824	1.67 Score on a Scale Standard Deviation 13.503
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 7 Day 1	-2.56 Score on a Scale Standard Deviation 21.350	1.01 Score on a Scale Standard Deviation 19.516
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 8 Day 1	-3.03 Score on a Scale Standard Deviation 17.979	1.01 Score on a Scale Standard Deviation 19.516
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 9 Day 1	-6.06 Score on a Scale Standard Deviation 20.101	-2.30 Score on a Scale Standard Deviation 23.454
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 2 Day 1	-3.68 Score on a Scale Standard Deviation 21.845	2.55 Score on a Scale Standard Deviation 15.298
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 3 Day 1	3.74 Score on a Scale Standard Deviation 14.362	-2.55 Score on a Scale Standard Deviation 19.823
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 4 Day 1	-2.24 Score on a Scale Standard Deviation 14.636	-0.49 Score on a Scale Standard Deviation 18.136
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 5 Day 1	7.50 Score on a Scale Standard Deviation 14.023	-1.91 Score on a Scale Standard Deviation 21.210
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 6 Day 1	10.96 Score on a Scale Standard Deviation 11.802	4.17 Score on a Scale Standard Deviation 19.447
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 7 Day 1	16.03 Score on a Scale Standard Deviation 22.428	-3.13 Score on a Scale Standard Deviation 19.715
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 8 Day 1	9.09 Score on a Scale Standard Deviation 13.670	2.15 Score on a Scale Standard Deviation 21.727
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global health status/QoL: Change at Cycle 9 Day 1	8.33 Score on a Scale Standard Deviation 20.412	-7.14 Score on a Scale Standard Deviation 28.211
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 8 Day 1	0.00 Score on a Scale Standard Deviation 0.000	0.51 Score on a Scale Standard Deviation 12.832
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 9 Day 1	0.00 Score on a Scale Standard Deviation 0.000	-2.30 Score on a Scale Standard Deviation 13.890
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 2 Day 1	-2.33 Score on a Scale Standard Deviation 30.338	-0.22 Score on a Scale Standard Deviation 26.351
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 3 Day 1	-9.77 Score on a Scale Standard Deviation 22.056	-1.54 Score on a Scale Standard Deviation 30.151
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 4 Day 1	0.00 Score on a Scale Standard Deviation 29.439	-4.85 Score on a Scale Standard Deviation 25.795
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 5 Day 1	-4.17 Score on a Scale Standard Deviation 25.291	-4.00 Score on a Scale Standard Deviation 25.098
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 6 Day 1	-14.04 Score on a Scale Standard Deviation 29.535	-2.92 Score on a Scale Standard Deviation 24.427
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 7 Day 1	-21.79 Score on a Scale Standard Deviation 29.174	-4.04 Score on a Scale Standard Deviation 24.661
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 8 Day 1	-13.64 Score on a Scale Standard Deviation 25.624	-7.58 Score on a Scale Standard Deviation 25.716
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Pain: Change at Cycle 9 Day 1	-19.70 Score on a Scale Standard Deviation 27.707	-5.17 Score on a Scale Standard Deviation 24.030
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 2 Day 1	2.38 Score on a Scale Standard Deviation 17.097	1.33 Score on a Scale Standard Deviation 24.162
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 3 Day 1	3.57 Score on a Scale Standard Deviation 16.578	-0.51 Score on a Scale Standard Deviation 23.930
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 4 Day 1	0.00 Score on a Scale Standard Deviation 16.667	2.42 Score on a Scale Standard Deviation 24.724
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 5 Day 1	3.51 Score on a Scale Standard Deviation 21.928	0.00 Score on a Scale Standard Deviation 28.054
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 6 Day 1	1.85 Score on a Scale Standard Deviation 13.873	-1.67 Score on a Scale Standard Deviation 19.900
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 7 Day 1	2.78 Score on a Scale Standard Deviation 30.011	2.02 Score on a Scale Standard Deviation 21.952
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 9 Day 1	6.67 Score on a Scale Standard Deviation 26.294	2.30 Score on a Scale Standard Deviation 17.663
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 2 Day 1	-2.33 Score on a Scale Standard Deviation 26.622	0.44 Score on a Scale Standard Deviation 24.195
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 3 Day 1	-6.90 Score on a Scale Standard Deviation 24.200	-0.51 Score on a Scale Standard Deviation 26.016
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 4 Day 1	-10.26 Score on a Scale Standard Deviation 29.468	-1.82 Score on a Scale Standard Deviation 19.687
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 5 Day 1	-15.00 Score on a Scale Standard Deviation 31.484	1.33 Score on a Scale Standard Deviation 30.087
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 6 Day 1	-17.54 Score on a Scale Standard Deviation 32.142	-4.17 Score on a Scale Standard Deviation 24.093
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 8 Day 1	-13.33 Score on a Scale Standard Deviation 54.885	3.03 Score on a Scale Standard Deviation 25.500
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 9 Day 1	-6.06 Score on a Scale Standard Deviation 38.925	5.75 Score on a Scale Standard Deviation 25.306
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 2 Day 1	4.65 Score on a Scale Standard Deviation 26.807	-2.25 Score on a Scale Standard Deviation 27.215
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 3 Day 1	-2.30 Score on a Scale Standard Deviation 15.252	-4.30 Score on a Scale Standard Deviation 22.163
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 4 Day 1	-1.28 Score on a Scale Standard Deviation 30.523	-3.09 Score on a Scale Standard Deviation 26.117
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Appetite loss: Change at Cycle 5 Day 1	3.33 Score on a Scale Standard Deviation 21.357	-1.36 Score on a Scale Standard Deviation 30.398
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Fatigue: Change at Cycle 7 Day 1	-1.71 Score on a Scale Standard Deviation 19.692	14.14 Score on a Scale Standard Deviation 20.838
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Nausea/Vomiting: Change at Cycle 7 Day 1	-1.28 Score on a Scale Standard Deviation 14.372	3.03 Score on a Scale Standard Deviation 13.472
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Dyspnoea: Change at Cycle 8 Day 1	16.67 Score on a Scale Standard Deviation 36.004	2.02 Score on a Scale Standard Deviation 21.952
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Insomnia: Change at Cycle 7 Day 1	-7.69 Score on a Scale Standard Deviation 41.172	1.01 Score on a Scale Standard Deviation 28.241
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Constipation: Change at Cycle 5 Day 1	5.00 Score on a Scale Standard Deviation 16.312	-0.68 Score on a Scale Standard Deviation 22.037
Change From Baseline of Patient-reported Outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Financial Problems: Change at Cycle 6 Day 1	-1.75 Score on a Scale Standard Deviation 23.501	-5.83 Score on a Scale Standard Deviation 27.099

SECONDARY outcome

Timeframe: Baseline (Day 1 of Cycle 1); Day 1 of Cycles 2 to 9 (Cycles 1-5 [Each cycle of 9 weeks], Cycles 6 to 9 [Each cycle of 12 weeks])

Skindex-16 questionnaire contains 16 questions related to quality of life in cancer participants. It consisted of a short 16-item assessment completed by the participant, with each item rated on a 7-point Likert scale (0=never bothered to 6=always bothered). Each raw score is multiplied by 16.667 to transform all responses to a linear scale from 0 (no effect) to 100 (effect experienced all the time). Responses to the Skindex-16 are categorized into 3 subscales: symptom, emotional \& functional; their respective scores are expressed in a linear scale from 0 to 100. Symptoms scale score was an average of items 1 to 4 expressed in a linear scale from 0 to 100, Emotions scale score was an average of items 5 to 11 expressed in a linear scale from 0 to 100 and Functioning scale score was an average of items 12 to 16 expressed in a linear scale from 0 to 100. A negative change from baseline indicates an improvement in the participants condition compared to the baseline.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 5 Day 1	-0.98 Score on a Scale Standard Deviation 15.205	-4.11 Score on a Scale Standard Deviation 18.062
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 7 Day 1	-3.89 Score on a Scale Standard Deviation 19.583	-6.00 Score on a Scale Standard Deviation 15.767
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 4 Day 1	5.30 Score on a Scale Standard Deviation 18.464	-6.62 Score on a Scale Standard Deviation 23.917
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 6 Day 1	-1.56 Score on a Scale Standard Deviation 16.307	-1.85 Score on a Scale Standard Deviation 21.419
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 7 Day 1	4.17 Score on a Scale Standard Deviation 23.233	0.69 Score on a Scale Standard Deviation 24.518
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 8 Day 1	5.00 Score on a Scale Standard Deviation 17.213	-2.96 Score on a Scale Standard Deviation 24.395
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 9 Day 1	8.33 Score on a Scale Standard Deviation 21.246	-3.42 Score on a Scale Standard Deviation 24.455
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 2 Day 1	-3.49 Score on a Scale Standard Deviation 19.183	-4.98 Score on a Scale Standard Deviation 23.650
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 3 Day 1	-5.00 Score on a Scale Standard Deviation 18.166	-4.76 Score on a Scale Standard Deviation 20.203
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 4 Day 1	-8.18 Score on a Scale Standard Deviation 24.119	-5.82 Score on a Scale Standard Deviation 23.275
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 5 Day 1	-7.06 Score on a Scale Standard Deviation 20.746	-3.76 Score on a Scale Standard Deviation 16.369
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 6 Day 1	-12.08 Score on a Scale Standard Deviation 27.022	-11.14 Score on a Scale Standard Deviation 18.113
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 8 Day 1	-7.33 Score on a Scale Standard Deviation 23.402	-7.00 Score on a Scale Standard Deviation 17.926
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Functioning: Change at Cycle 9 Day 1	-9.39 Score on a Scale Standard Deviation 21.072	-5.60 Score on a Scale Standard Deviation 20.965
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 2 Day 1	0.99 Score on a Scale Standard Deviation 18.788	-1.31 Score on a Scale Standard Deviation 21.607
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Symptoms: Change at Cycle 3 Day 1	3.85 Score on a Scale Standard Deviation 16.580	-0.26 Score on a Scale Standard Deviation 24.158
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 3 Day 1	-7.92 Score on a Scale Standard Deviation 18.033	-8.60 Score on a Scale Standard Deviation 25.641
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 4 Day 1	-3.97 Score on a Scale Standard Deviation 17.175	-11.45 Score on a Scale Standard Deviation 24.215
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 5 Day 1	-0.14 Score on a Scale Standard Deviation 12.835	-10.25 Score on a Scale Standard Deviation 24.646
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 6 Day 1	-9.08 Score on a Scale Standard Deviation 22.824	-19.73 Score on a Scale Standard Deviation 27.304
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 7 Day 1	6.55 Score on a Scale Standard Deviation 17.053	-13.65 Score on a Scale Standard Deviation 27.132
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 8 Day 1	-0.71 Score on a Scale Standard Deviation 8.478	-13.97 Score on a Scale Standard Deviation 25.001
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 9 Day 1	5.70 Score on a Scale Standard Deviation 14.711	-15.08 Score on a Scale Standard Deviation 31.843
Change From Baseline of Patient-reported Outcomes in Skindex-16 Questionnaire Emotions: Change at Cycle 2 Day 1	-6.90 Score on a Scale Standard Deviation 24.422	-8.93 Score on a Scale Standard Deviation 27.767

SECONDARY outcome

Timeframe: Up to 1422 days (approximately 46 months)

Population: The safety analysis set (SAF) included all enrolled participants who received any study drug for each group.

An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as AEs that developed or worsened during the on-treatment period and treatment-related AEs that occur during post-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Participants with any TEAEs	51 Participants	83 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs Participants with any Serious TEAEs	16 Participants	31 Participants

SECONDARY outcome

Timeframe: At pre-infusion on Cycle 1 Day 22 and Cycle 3 Day 1 (Each cycle of 9 weeks)

Population: The PK analysis set included all participants who received any cemiplimab and had at least one non-missing post-baseline measurement of cemiplimab concentration in serum. "Number analyzed" signifies those participants who were evaluable at specific time points.

Ctrough of cemiplimab reported.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Serum Concentration at Pre-infusion (Ctrough) Cycle 1 Day 22	28.3 Milligram per Liter (mg/L) Standard Deviation 18.4	29.8 Milligram per Liter (mg/L) Standard Deviation 12.0
Serum Concentration at Pre-infusion (Ctrough) Cycle 3 Day 1	60.6 Milligram per Liter (mg/L) Standard Deviation 28.2	68.6 Milligram per Liter (mg/L) Standard Deviation 32.8

SECONDARY outcome

Timeframe: At end-of-infusion (within 10 minutes after the end of infusion) on Cycle 1 Day 1 and Cycle 3 Day 1 (Each cycle of 9 weeks)

Population: The pharmacokinetics (PK) analysis set included all participants who received any cemiplimab and had at least one non-missing post-baseline measurement of cemiplimab concentration in serum. "Number analyzed" signifies those participants who were evaluable at specific time points.

Cmax of cemiplimab was reported.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=54 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Serum Concentration at End of Infusion (Cmax) Cycle 1 Day 1	103 mg/L Standard Deviation 25.2	104 mg/L Standard Deviation 45.5
Serum Concentration at End of Infusion (Cmax) Cycle 3 Day 1	160 mg/L Standard Deviation 52.7	192 mg/L Standard Deviation 91.6

SECONDARY outcome

Timeframe: Cycle 1: Days 1 and 43; Cycles 3 and 5: Day 1 (Each cycle of 9 weeks)

Population: The anti-drug antibody set included all participants who received cemiplimab and who had at least 1 non-missing result in the ADA assay after the first dose of the study drug.

Immunogenicity was characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses \< 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, ≥ 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the cemiplimab ADA assay post first dose when baseline results = negative or missing.

Outcome measures

Outcome measures
Measure	Group 1: Metastatic BCC (mBCC) n=52 Participants Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=81 Participants Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Number of Participants With Anti-Drug Antibody (ADA) Status Negative ADA	50 Participants	74 Participants
Number of Participants With Anti-Drug Antibody (ADA) Status Pre-Existing ADA	2 Participants	2 Participants
Number of Participants With Anti-Drug Antibody (ADA) Status Treatment-emergent ADA	0 Participants	5 Participants

Adverse Events

Group 1: Metastatic BCC (mBCC)

Serious events: 18 serious events

Other events: 50 other events

Deaths: 22 deaths

Group 2: Unresectable Locally Advanced BCC (laBCC)

Serious events: 33 serious events

Other events: 76 other events

Deaths: 21 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Group 1: Metastatic BCC (mBCC) n=54 participants at risk Participants with metastatic BCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or CR.	Group 2: Unresectable Locally Advanced BCC (laBCC) n=84 participants at risk Participants with unresectable laBCC received IV infusion of cemiplimab at a dose of 350 mg Q3W for up to 93 weeks of treatment cycles (cycles 1-5 \[each cycle of 9 weeks\] followed by cycles 6-9 \[each cycle of 12 weeks\]) or until PD, unacceptable toxicity, withdrawal of consent, or confirmed CR.
Gastrointestinal disorders Nausea	11.1% 6/54 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	15.5% 13/84 • Number of events 19 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Gastrointestinal disorders Vomiting	13.0% 7/54 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 10 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Gastrointestinal disorders Constipation	22.2% 12/54 • Number of events 14 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Gastrointestinal disorders Diarrhoea	37.0% 20/54 • Number of events 26 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	23.8% 20/84 • Number of events 33 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Gastrointestinal disorders Abdominal pain	7.4% 4/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Blood and lymphatic system disorders Anaemia	11.1% 6/54 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	15.5% 13/84 • Number of events 19 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
General disorders Pyrexia	13.0% 7/54 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
General disorders Asthenia	9.3% 5/54 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	20.2% 17/84 • Number of events 27 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
General disorders Fatigue	44.4% 24/54 • Number of events 32 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	29.8% 25/84 • Number of events 35 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
General disorders Oedema peripheral	13.0% 7/54 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Investigations Alanine aminotransferase increased	5.6% 3/54 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	4.8% 4/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Investigations Blood creatinine increased	7.4% 4/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	9.5% 8/84 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Metabolism and nutrition disorders Decreased appetite	11.1% 6/54 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	16.7% 14/84 • Number of events 18 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Metabolism and nutrition disorders Hypoalbuminaemia	1.9% 1/54 • Number of events 2 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 12 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Metabolism and nutrition disorders Hypokalaemia	7.4% 4/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	4.8% 4/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Metabolism and nutrition disorders Hyperglycaemia	11.1% 6/54 • Number of events 8 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	2.4% 2/84 • Number of events 2 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Infections and infestations Urinary tract infection	7.4% 4/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	11.9% 10/84 • Number of events 11 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Musculoskeletal and connective tissue disorders Back pain	9.3% 5/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 9/54 • Number of events 10 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	19.0% 16/84 • Number of events 24 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Musculoskeletal and connective tissue disorders Pain in extremity	9.3% 5/54 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	4.8% 4/84 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Skin and subcutaneous tissue disorders Rash	7.4% 4/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Skin and subcutaneous tissue disorders Pruritus	14.8% 8/54 • Number of events 13 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	23.8% 20/84 • Number of events 24 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Nervous system disorders Headache	13.0% 7/54 • Number of events 8 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	14.3% 12/84 • Number of events 14 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Respiratory, thoracic and mediastinal disorders Cough	7.4% 4/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	11.9% 10/84 • Number of events 14 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.4% 4/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	13.1% 11/84 • Number of events 18 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Endocrine disorders Hypothyroidism	7.4% 4/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	9.5% 8/84 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
General disorders Influenza like illness	3.7% 2/54 • Number of events 2 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
General disorders Pain	5.6% 3/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	2.4% 2/84 • Number of events 2 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Skin and subcutaneous tissue disorders Dry skin	9.3% 5/54 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	8.3% 7/84 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Skin and subcutaneous tissue disorders Actinic keratosis	5.6% 3/54 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	8.3% 7/84 • Number of events 10 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Skin and subcutaneous tissue disorders Rash maculo-papular	9.3% 5/54 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/54 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Skin and subcutaneous tissue disorders Eczema	9.3% 5/54 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Gastrointestinal disorders Dry mouth	7.4% 4/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	3.6% 3/84 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 3/54 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Musculoskeletal and connective tissue disorders Myalgia	9.3% 5/54 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	3.6% 3/84 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Musculoskeletal and connective tissue disorders Neck pain	7.4% 4/54 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	2.4% 2/84 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Infections and infestations Bronchitis	0.00% 0/54 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Infections and infestations Upper respiratory tract infection	5.6% 3/54 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Infections and infestations Conjunctivitis	0.00% 0/54 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Investigations Weight decreased	9.3% 5/54 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	8.3% 7/84 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Investigations Blood creatine phosphokinase increased	7.4% 4/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 8 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Investigations Weight increased	14.8% 8/54 • Number of events 12 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	2.4% 2/84 • Number of events 2 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	1.9% 1/54 • Number of events 1 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	10.7% 9/84 • Number of events 12 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	5.6% 3/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	9.5% 8/84 • Number of events 9 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	1.9% 1/54 • Number of events 1 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Blood and lymphatic system disorders Leukocytosis	1.9% 1/54 • Number of events 1 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	7.1% 6/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Nervous system disorders Dizziness	9.3% 5/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	8.3% 7/84 • Number of events 8 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Endocrine disorders Hyperthyroidism	9.3% 5/54 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	2.4% 2/84 • Number of events 2 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Vascular disorders Hypertension	22.2% 12/54 • Number of events 33 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	10.7% 9/84 • Number of events 15 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Eye disorders Cataract	0.00% 0/54 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 6 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Injury, poisoning and procedural complications Fall	7.4% 4/54 • Number of events 7 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	6.0% 5/84 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Injury, poisoning and procedural complications Infusion related reaction	5.6% 3/54 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	0.00% 0/84 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Psychiatric disorders Anxiety	5.6% 3/54 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	3.6% 3/84 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Renal and urinary disorders Haematuria	7.4% 4/54 • Number of events 5 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	3.6% 3/84 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)
Nervous system disorders Paraesthesia	5.6% 3/54 • Number of events 3 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)	4.8% 4/84 • Number of events 4 • From signature of informed consent until 105 days after last dose of study drug (up to 2129 days)