Trial Outcomes & Findings for Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-line Therapy: Retrospective Study (J-DART) (NCT NCT05012865)

NCT ID: NCT05012865

Last Updated: 2023-12-06

Results Overview

ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (\>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair. Participants whose score was not known were reported against "Unknown'.

• Recruitment status: COMPLETED
• Target enrollment: 48 participants
• Primary outcome timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study
• Results posted on: 2023-12-06

Participant Flow

Data from participants with metastatic renal cell carcinoma (mRCC) who initiated treatment with avelumab plus axitinib as a first-line therapy in Japan, between 20-Dec-2019 and 20- Dec-2020 were included in this study. Data was retrieved and analyzed during approximately 4.5 months of this observational retrospective study.

All decisions regarding clinical management and treatment of the participants were made by the investigator as part of standard care in real-world clinical setting and were not dependent upon the participants' participation in the study.

Participant milestones

Measure	Avelumab + Axitinib as First-line Therapy Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Age, Continuous	68.7 Years STANDARD_DEVIATION 11.8 • n=48 Participants
Sex: Female, Male Female	15 Participants n=48 Participants
Sex: Female, Male Male	33 Participants n=48 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

ECOG-PS assessed participant's performance status on a 5 point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2= ambulatory (>50% of waking hours), capable of all self-care, unable to carry out any work activities; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair. Participants whose score was not known were reported against "Unknown'.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0	29 Participants
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 1	9 Participants
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 2	3 Participants
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 3	0 Participants
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 4	0 Participants
Number of Participants Categorized According to Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Unknown	7 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

IMDC criteria had 6 risk factors: Karnofsky Performance Status less than (<) 80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <1 year; corrected serum calcium; neutrophils and platelets more than (>) upper limit of normal (ULN); hemoglobin <lower limit of normal (LLN). Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (more than or equal to [>=]3 factors).

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score Favorable	8 Participants
Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score Intermediate	26 Participants
Number of Participants Categorized According to International Metastatic RCC Database Consortium (IMDC) Risk Score Poor	14 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer [mcm]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at *400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at *100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. Participants whose Fuhrman Grade were not known were reported against "Unknown'.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Fuhrman Grade Grade 1	2 Participants
Number of Participants Categorized According to Fuhrman Grade Grade 2	14 Participants
Number of Participants Categorized According to Fuhrman Grade Grade 3	12 Participants
Number of Participants Categorized According to Fuhrman Grade Grade 4	8 Participants
Number of Participants Categorized According to Fuhrman Grade Unknown	12 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure participants were reported according to the different histological type of mRCC including clear renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma and others.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Histological Type Clear renal cell carcinoma	39 Participants
Number of Participants Categorized According to Histological Type Papillary renal cell carcinoma	1 Participants
Number of Participants Categorized According to Histological Type Chromophobe renal cell carcinoma	1 Participants
Number of Participants Categorized According to Histological Type Others	7 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants were categorized as "Yes" or "No" according to presence of sarcomatoid component were reported.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Presence of Sarcomatoid Component Yes	5 Participants
Number of Participants Categorized According to Presence of Sarcomatoid Component No	43 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

TNM system is based on size of primary tumor (T), amount of spread to lymph nodes (N) and presence of metastases (M). T1: tumor <=20 millimeters (mm), T2: tumor >20 mm to <=50 mm, T3: >50 mm and TX: tumor cannot be assessed. N0: no lymph node metastases, N1: metastases to ipsilateral level I, II axillary lymph nodes, NX: Regional lymph nodes cannot be assessed. M0: no clinical/radiographic evidence of distant metastases, M1: distant detectable metastases as determined by clinical and radiographic means and/or histologically proven >0.2 mm, and MX: metastases cannot be assessed.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification TX	3 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification T4	2 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification T0	3 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification T1	17 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification T2	3 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification T3	20 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification NX	3 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification N0	33 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification N1	12 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification MX	2 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification M0	6 Participants
Number of Participants Categorized According to Tumor-node-metastases (TNM) Classification M1	40 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure participants were reported according to number of metastatic organs as a) 1 and, b) 2 or more.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=43 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Number of Metastatic Organs Metastatic organ 1	22 Participants
Number of Participants Categorized According to Number of Metastatic Organs Metastatic organs 2 or more	21 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Sites of metastases included: metastases of lung, liver, bone, brain, regional lymph nodes, distant nodal metastases and others. One participant could have more than 1 type of metastases.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=43 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Type of Site of Metastases Lung metastases	25 Participants
Number of Participants Categorized According to Type of Site of Metastases Liver metastases	5 Participants
Number of Participants Categorized According to Type of Site of Metastases Bone metastases	14 Participants
Number of Participants Categorized According to Type of Site of Metastases Brain metastases	1 Participants
Number of Participants Categorized According to Type of Site of Metastases Regional lymph node metastasis	11 Participants
Number of Participants Categorized According to Type of Site of Metastases Distant nodal metastasis	4 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure participants were reported as "Yes" or "No" according to presence of complications.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants According to Presence of Complications Yes	34 Participants
Number of Participants According to Presence of Complications No	14 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants who underwent nephrectomy previously, were reported as "Yes' or "No".

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Who Underwent Nephrectomy Previously Yes	32 Participants
Number of Participants Who Underwent Nephrectomy Previously No	16 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

GFR is an index of kidney function that describes the flow of filtered fluid through the kidney. eGFR was reported in millimeter per minute per 1.73 square meter (ml/min/1.73 m^2).

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=44 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Estimated Glomerular Filtration Rate (eGFR)	49.62 ml/min/1.73 m^2 Standard Deviation 23.37

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Proteinuria is the presence of an excess of serum proteins in the urine, which may be an early sign of kidney disease. Here, negative = <15 milligrams per deciliter (mg/dL), positive=15-29 mg/dL, 1 = 30 mg/dL, 2= 100 mg/dL, 3= 300 mg/dL.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=34 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Proteinuria Negative	19 Participants
Number of Participants With Proteinuria Positive	8 Participants
Number of Participants With Proteinuria 1	3 Participants
Number of Participants With Proteinuria 2	2 Participants
Number of Participants With Proteinuria 3	2 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=44 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
C-reactive Protein (CRP)	1.779 Milligrams per deciliter Standard Deviation 3.511

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants with smoking history were reported as No (No smoking history, never smoked), No (Smoking history exists, quit smoking), Yes (currently smoking). Participant whose smoking status was not known were reported against "Unknown".

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Smoking Status No (No smoking history)	16 Participants
Number of Participants Categorized According to Smoking Status No (Smoking history exists)	21 Participants
Number of Participants Categorized According to Smoking Status Yes	5 Participants
Number of Participants Categorized According to Smoking Status Unknown	6 Participants

PRIMARY outcome

Timeframe: Baseline (before first dose of avelumab plus axitinib, during data identification period from 20-Dec-2019 to 20-Dec-2020 [approximately 1 year]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants who took concomitant drugs were reported.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Who Took Concomitant Drugs Yes	37 Participants
Number of Participants Who Took Concomitant Drugs No	11 Participants

SECONDARY outcome

Timeframe: From index date up to 20-June-2021, where index date was date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020 (maximum observation period was of 1.5 years approximately).

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

TTF was defined as the time from the date of first dose of avelumab plus axitinib as first line therapy to the end of treatment for any cause earlier, including death. Kaplan-Meier method was used for analysis.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Time to Treatment Failure (TTF) of Avelumab Plus Axitinib as a First-line Therapy	15.2 Months Interval 7.4 to Since participants with events were less hence upper limit of 95% CI could not be estimated.

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to disease progression or death due to any cause/censored date (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approx 1.6 years]); retrieved data was analyzed during 4.5 months of this OS

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

PFS was defined as time from start of avelumab/axitinib treatment to date of first disease progression (DP) (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, whichever came first. If there were no clinical records of death or disease progression, they were censored at the date of initiation of the next line of therapy for the participants undertaking 2 or more lines of therapy based on the record, or at their last visit date during the study period for the participants undertaking only 1 line of therapy based on the record.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Real-world Progression Free Survival (PFS)	15.3 Months Interval 9.7 to Since participants with events were less hence upper limit of 95% CI could not be estimated.

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to CR or PR (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point.

Objective response was defined as percentage of participants with complete response (CR) or partial response (PR) as the best adjudication result in a method complied with RECIST version. 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgment. CR: disappearance of all non-nodal target lesions and of all non-target lesions. In addition, any pathological lymph nodes assigned as target lesions/ non-target lesions must have a reduction in short axis to <10 mm. PR: at least a 30 percent (%) decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=43 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Percentage of Participants With Objective Response	48.8 Percentage of participants Interval 33.3 to 64.5

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]) retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

TTF was defined as the time from the date of first dose of avelumab plus axitinib to the end of treatment for any cause earlier, including death. Kaplan-Meier method was used for analysis.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment TTF: Avelumab	NA Months Interval 5.4 to Since participants with events were less hence median and upper limit of 95% CI could not be estimated.
Time to Treatment Failure in Participants With Avelumab and Axitinib Treatment TTF: Axitinib	10.5 Months Interval 3.9 to Since participants with events were less hence upper limit of 95% CI could not be estimated.

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.6 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants who discontinued and had interruption of avelumab and axitinib treatment were reported.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment Avelumab: Discontinued	8 Participants
Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment Avelumab: Interruption	25 Participants
Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment Axitinib: Discontinued	11 Participants
Number of Participants With Discontinuation and Interruption of Avelumab and Axitinib Treatment Axitinib: Interruption	28 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, participant who discontinued the avelumab treatment due to reasons including disease progression, adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for discontinuation of treatment.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=8 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Reason for Discontinuation of Avelumab Treatment Disease progression	4 Participants
Number of Participants With Reason for Discontinuation of Avelumab Treatment Adverse event	1 Participants
Number of Participants With Reason for Discontinuation of Avelumab Treatment Sufficient efficacy	1 Participants
Number of Participants With Reason for Discontinuation of Avelumab Treatment Others	3 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, participant who discontinued the axitinib treatment due to reasons including disease progression, adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for discontinuation of treatment.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=11 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Reason for Discontinuation of Axitinib Treatment Disease progression	3 Participants
Number of Participants With Reason for Discontinuation of Axitinib Treatment Adverse event	3 Participants
Number of Participants With Reason for Discontinuation of Axitinib Treatment Sufficient efficacy	2 Participants
Number of Participants With Reason for Discontinuation of Axitinib Treatment Others	3 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, participant who had treatment interruption due to reasons including adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for interruption of treatment.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=25 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Reason for Interruption of Avelumab Treatment Adverse event	19 Participants
Number of Participants With Reason for Interruption of Avelumab Treatment Sufficient efficacy	2 Participants
Number of Participants With Reason for Interruption of Avelumab Treatment Others	10 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, participant who had treatment interruption due to reasons including adverse event, sufficient efficacy and others were reported. One participant could have more than 1 reason for interruption of treatment.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=28 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Reason for Interruption of Axitinib Treatment Adverse event	24 Participants
Number of Participants With Reason for Interruption of Axitinib Treatment Sufficient efficacy	2 Participants
Number of Participants With Reason for Interruption of Axitinib Treatment Others	9 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, participants who had dose modification (increase/decrease) were reported.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Dose Modification of Axitinib Treatment Yes	24 Participants
Number of Participants With Dose Modification of Axitinib Treatment No	24 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants were reported against the reasons for dose modification of axitinib treatment. One participant could have more than 1 reason for modification of axitinib treatment.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=24 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants According to Reason for Dose Modification of Axitinib Treatment Adverse event	19 Participants
Number of Participants According to Reason for Dose Modification of Axitinib Treatment Others	8 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Immune-related adverse events (irAEs) was defined as the serious side effect of immune checkpoint inhibitor therapy for participants with advanced cancer.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=5 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment Prednisolone	15.00 Milligrams Standard Deviation 10.8
Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment Methylprednisolone sodium succinate	234.38 Milligrams Standard Deviation 110.5
Cumulative Dose of Corticosteroid for Immune-related Adverse Events (irAE) During Avelumab Plus Axitinib Treatment Hydrocortisone sodium succinate	50.00 Milligrams

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=5 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment Prednisolone	25.0 Days Interval 14.0 to 172.0
Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment Methylprednisolone sodium succinate	1.0 Days Interval 1.0 to 1.0
Duration of Corticosteroid Treatment for irAE During Avelumab Plus Axitinib Treatment Hydrocortisone sodium succinate	1.0 Days Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=5 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment Prednisolone	2 Doses
Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment Methylprednisolone sodium succinate	2 Doses
Number of Corticosteroid Doses for irAE During Avelumab Plus Axitinib Treatment Hydrocortisone sodium succinate	1 Doses

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study.

In this outcome measure, number of participants who were on pre-medication and presence of these medications were reason for potential infusion-related reaction of avelumab, were reported.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=48 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants With Presence of Pre-medication for Potential Infusion-related Reaction of Avelumab Yes	45 Participants
Number of Participants With Presence of Pre-medication for Potential Infusion-related Reaction of Avelumab No	3 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who were on pre-medication and presence of these medications were reason for potential infusion-related reaction of avelumab, were reported according to type of pre-medications. One participant could have taken more than 1 type of pre-medication.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=45 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab Acetaminophen	39 Participants
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab Chlorpheniramine maleate	22 Participants
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab Diphenhydramine hydrochloride	22 Participants
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab Famotidine	4 Participants
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab Diclofenac sodium	1 Participants
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab Hydrocortisone sodium succinate	1 Participants
Number of Participants Categorized According to Type of Pre-medication for Infusion-related Reaction of Avelumab Methylprednisolone sodium succinate	1 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib initiation to end of treatment (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who received any treatment for infusion-related reaction of avelumab were reported.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=45 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants Who Received Treatment for Infusion-related Reaction of Avelumab	8 Participants

SECONDARY outcome

Timeframe: From avelumab plus axitinib end of treatment to end of study observation (during data identification period from 20-Dec-2019 to 20-Jun-2021 [approximately 1.5 years]); retrieved data was analyzed during 4.5 months of this observational study

Population: Full analysis set included the medical records extracted for the purpose of the study from all eligible participants who were included in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

In this outcome measure, number of participants who received subsequent treatment after avelumab plus axitinib therapy, were reported according to type of subsequent treatment including tyrosine kinase inhibitors (TKI), immuno-oncology (IO) drugs and others. Categories with at least 1 non-zero data are reported below.

Outcome measures

Measure	Avelumab + Axitinib as First-line Therapy n=12 Participants Participants with mRCC treated with avelumab plus axitinib as a first-line therapy between 20-Dec-2019 to 20-Dec-2020 in Japan in real world practice. Participants were followed up to 20-Jun-2021 from index date (date of first prescription for avelumab plus axitinib between 20-Dec-2019 and 20 December 2020).
Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib TKI: Pazopanib	1 Participants
Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib TKI: Cabozantinib	7 Participants
Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib IO: Nivolumab	3 Participants
Number of Participants by Type of Received Subsequent Treatment After Avelumab Plus Axitinib Others: Axitinib + Pembrolizumab	1 Participants

Adverse Events

Avelumab + Axitinib as First-line Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER