Trial Outcomes & Findings for A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia) (NCT NCT04849416)
NCT ID: NCT04849416
Last Updated: 2025-06-18
Results Overview
ORR was assessed by an Independent Review Committee (IRC). It was estimated based on the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Two-sided 95% CI was calculated using the exact binomial distribution. PAS consisted of participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
87 participants
Primary outcome timeframe
Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
Mantle Cell Lymphoma (MCL) Cohort
Participants with MCL received 200 milligrams (mg) of LOXO-305 administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Cohort
Participants with CLL or SLL received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Other Cohort
Participants with other B cell non-Hodgkin lymphoma (NHL) received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
17
|
31
|
|
Overall Study
Received At Least One Dose of Study Drug
|
39
|
17
|
31
|
|
Overall Study
COMPLETED
|
18
|
3
|
17
|
|
Overall Study
NOT COMPLETED
|
21
|
14
|
14
|
Reasons for withdrawal
| Measure |
Mantle Cell Lymphoma (MCL) Cohort
Participants with MCL received 200 milligrams (mg) of LOXO-305 administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Cohort
Participants with CLL or SLL received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Other Cohort
Participants with other B cell non-Hodgkin lymphoma (NHL) received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Ongoing Treatment
|
12
|
5
|
3
|
|
Overall Study
On Post-Treatment Follow-up
|
8
|
9
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)
Baseline characteristics by cohort
| Measure |
MCL Cohort
n=39 Participants
Participants with MCL who received 200 mg of LOXO-305 administered orally QD. on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
CLL/SLL Cohort
n=17 Participants
Participants with CLL or SLL who received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Other Cohort
n=31 Participants
Participants with other B cell NHL who received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
39 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
39 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
39 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)Population: All participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
ORR was assessed by an Independent Review Committee (IRC). It was estimated based on the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Two-sided 95% CI was calculated using the exact binomial distribution. PAS consisted of participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
Outcome measures
| Measure |
PAS - MCL Group
n=28 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee
|
71.4 Percentage of participants
Interval 51.3 to 86.8
|
SECONDARY outcome
Timeframe: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)Population: All participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
ORR was assessed by the Investigator. It was estimated based on the percentage of participants with BOR of CR or PR. Two-sided 95% CI was calculated using the exact binomial distribution.
Outcome measures
| Measure |
PAS - MCL Group
n=28 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
PAS ORR: ORR Assessed by Investigator
|
64.3 Percentage of participants
Interval 44.1 to 81.4
|
SECONDARY outcome
Timeframe: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)Population: All participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
BOR was assessed by the IRC and Investigator. Best overall assessment categories include (in descending order of extent of response): CR, PR, SD, PD, and NE. Two-sided 95% CI was calculated using the exact binomial distribution.
Outcome measures
| Measure |
PAS - MCL Group
n=28 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
CR by IRC
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
PR by IRC
|
57.1 Percentage of participants
Interval 37.2 to 75.5
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
SD by IRC
|
7.1 Percentage of participants
Interval 0.9 to 23.5
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
PD by IRC
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
PR by Investigator
|
50.0 Percentage of participants
Interval 30.7 to 69.4
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
NE by Investigator
|
7.1 Percentage of participants
Interval 0.9 to 23.5
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
NE by IRC
|
7.1 Percentage of participants
Interval 0.9 to 23.5
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
CR by Investigator
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
SD by Investigator
|
10.7 Percentage of participants
Interval 2.3 to 28.2
|
|
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
PD by Investigator
|
17.9 Percentage of participants
Interval 6.1 to 36.9
|
SECONDARY outcome
Timeframe: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 100 Weeks)Population: All eligible participants who had Central histologically confirmed non-blastoid MCL with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, had measurable disease at baseline as assessed using Lugano criteria and received at least 1 dose of study drug with response. Number of participants censored for IRC assessment:13. Number of participants censored for Investigator assessment:8.
DOR was assessed by the Investigator and IRC. DOR is defined as the number of months from the date of the first documented response to the date of PD or death, whichever occurs earlier. Participants who are alive and without documented PD as of data analysis cutoff date will be censored.
Outcome measures
| Measure |
PAS - MCL Group
n=20 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
PAS: Duration of Response (DOR)
IRC Assessment
|
NA Months
Interval 4.83 to
Median and upper limit of the 95% Confidence Interval (CI) was not evaluable because there were insufficient number of participants with events.
|
|
PAS: Duration of Response (DOR)
Investigator Assessment
|
11.50 Months
Interval 3.68 to
The upper limit of 95% CI was not evaluable because there were insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Date of First Dose to Progressive Disease or Death from Any Cause (Up to 100 weeks)Population: All eligible participants who had Central histologically confirmed non-blastoid MCL with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, had measurable disease at baseline as assessed using Lugano criteria and received at least 1 dose of study drug. Number of participants censored for IRC assessment: 15. Number of participants censored for Investigator assessment: 10.
PFS was assessed by the IRC and Investigator. PFS is defined as the number of months from the date of the first dose of study drug to the earlier of documented PD or death due to any cause. Participants who are alive and without documented PD as of data analysis cutoff date were censored.
Outcome measures
| Measure |
PAS - MCL Group
n=28 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
PAS: Progression Free Survival (PFS)
IRC Assessment
|
9.43 Months
Interval 5.32 to
Upper limit CI was not evaluable because there were insufficient number of participants with events.
|
|
PAS: Progression Free Survival (PFS)
Investigator Assessment
|
6.80 Months
Interval 3.61 to 13.34
|
SECONDARY outcome
Timeframe: Date of First Dose to Date of Death from Any Cause (Up to 100 weeks)Population: All eligible participants who had Central histologically confirmed non-blastoid MCL with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, had measurable disease at baseline as assessed using Lugano criteria and received at least 1 dose of study drug. Number of participants censored: 16.
OS is defined as the number of months elapsed between the date of the first dose of study drug and the date of death from any cause. Participants who are alive or lost to follow-up as of the data cutoff date will be censored.
Outcome measures
| Measure |
PAS - MCL Group
n=28 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
PAS: Overall Survival (OS)
|
15.47 Months
Interval 8.67 to
Upper limit CI was not evaluable because there were insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.Population: All participants who received at least one dose of study drug and had evaluable intensive PK data per protocol.
PK: AUC\[0-tlast\] of LOXO-305
Outcome measures
| Measure |
PAS - MCL Group
n=13 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305
Cycle 1 Day 1
|
62700 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 15.0
|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305
Cycle 1 Day 8
|
123000 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 38.1
|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305
Cycle 2 Day 1
|
137000 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28.7
|
|
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305
Cycle 4 Day 1
|
46600 nanogram hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 20.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.Population: All participants who received at least one dose of study drug and had evaluable intensive PK data per protocol.
PK: Cmax of LOXO-305
Outcome measures
| Measure |
PAS - MCL Group
n=13 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
PK: Maximum Concentration (Cmax) of LOXO-305
Cycle 1 Day 1
|
4800 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 14.7
|
|
PK: Maximum Concentration (Cmax) of LOXO-305
Cycle 1 Day 8
|
8380 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35.3
|
|
PK: Maximum Concentration (Cmax) of LOXO-305
Cycle 2 Day 1
|
9080 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.3
|
|
PK: Maximum Concentration (Cmax) of LOXO-305
Cycle 4 Day 1
|
7890 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 22.5
|
SECONDARY outcome
Timeframe: Baseline, 7 Days After Treatment Discontinuation (Up To 100 Weeks)Population: All participants who had Central histologically confirmed non-blastoid MCL with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, had measurable disease at baseline as assessed using Lugano criteria and received at least 1 dose of study drug and EORTC QLQ-C30 data.
EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms.
Outcome measures
| Measure |
PAS - MCL Group
n=27 Participants
Participants received 200 mg of LOXO-305 administered orally QD.
|
|---|---|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Global health status
|
2.5 score on a scale
Standard Error 4.78
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Functional scale: Physical functioning
|
0.8 score on a scale
Standard Error 2.96
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Functional scale: Cognitive functioning
|
-1.0 score on a scale
Standard Error 1.73
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Fatigue
|
-1.3 score on a scale
Standard Error 3.80
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Nausea and vomiting
|
0.0 score on a scale
Standard Error 1.43
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Pain
|
-3.9 score on a scale
Standard Error 2.27
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Insomnia
|
2.0 score on a scale
Standard Error 3.47
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Appetite loss
|
-2.0 score on a scale
Standard Error 4.49
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Constipation
|
-3.9 score on a scale
Standard Error 2.68
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Diarrhea
|
0.0 score on a scale
Standard Error 0.00
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Functional scale: Role functioning
|
-2.9 score on a scale
Standard Error 3.57
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Functional scale: Emotional functioning
|
-2.0 score on a scale
Standard Error 1.68
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Functional scale: Social functioning
|
-7.8 score on a scale
Standard Error 3.81
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Dyspnea
|
-2.0 score on a scale
Standard Error 1.96
|
|
PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Symptom scale: Financial difficulties
|
3.9 score on a scale
Standard Error 4.85
|
Adverse Events
200 mg LOXO-305 QD
Serious events: 33 serious events
Other events: 81 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
200 mg LOXO-305 QD
n=87 participants at risk
Participants received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Myelosuppression
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
1.1%
1/87 • Number of events 2 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Death
|
2.3%
2/87 • Number of events 2 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Bronchitis
|
2.3%
2/87 • Number of events 2 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Covid-19
|
3.4%
3/87 • Number of events 3 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Covid-19 pneumonia
|
2.3%
2/87 • Number of events 2 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Infection
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Pneumonia
|
4.6%
4/87 • Number of events 4 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Pneumonia viral
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Platelet count decreased
|
1.1%
1/87 • Number of events 2 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour necrosis
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Nervous system disorders
Cerebral ischaemia
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/87 • Number of events 2 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Vascular disorders
Haemorrhage
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Vascular disorders
Shock
|
1.1%
1/87 • Number of events 1 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
Other adverse events
| Measure |
200 mg LOXO-305 QD
n=87 participants at risk
Participants received 200 mg of LOXO-305 administered orally QD on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.0%
27/87 • Number of events 41 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.2%
8/87 • Number of events 10 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.9%
6/87 • Number of events 21 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.5%
10/87 • Number of events 32 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Cardiac disorders
Sinus tachycardia
|
6.9%
6/87 • Number of events 6 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
9.2%
8/87 • Number of events 12 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.7%
5/87 • Number of events 5 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Constipation
|
8.0%
7/87 • Number of events 7 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.6%
11/87 • Number of events 14 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
5/87 • Number of events 5 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Asthenia
|
5.7%
5/87 • Number of events 6 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Oedema peripheral
|
5.7%
5/87 • Number of events 5 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
General disorders
Pyrexia
|
14.9%
13/87 • Number of events 16 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Covid-19
|
16.1%
14/87 • Number of events 14 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Pneumonia
|
10.3%
9/87 • Number of events 14 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.2%
8/87 • Number of events 9 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
7/87 • Number of events 8 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Alanine aminotransferase increased
|
10.3%
9/87 • Number of events 12 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Aspartate aminotransferase increased
|
16.1%
14/87 • Number of events 20 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Bilirubin conjugated increased
|
5.7%
5/87 • Number of events 5 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Blood alkaline phosphatase increased
|
9.2%
8/87 • Number of events 9 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Blood bilirubin increased
|
23.0%
20/87 • Number of events 39 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Blood creatinine increased
|
12.6%
11/87 • Number of events 22 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Blood lactate dehydrogenase increased
|
14.9%
13/87 • Number of events 20 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.9%
6/87 • Number of events 9 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Lymphocyte count decreased
|
8.0%
7/87 • Number of events 7 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Neutrophil count decreased
|
29.9%
26/87 • Number of events 43 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Platelet count decreased
|
14.9%
13/87 • Number of events 17 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
Weight increased
|
11.5%
10/87 • Number of events 11 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Investigations
White blood cell count decreased
|
21.8%
19/87 • Number of events 39 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.7%
5/87 • Number of events 7 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.1%
14/87 • Number of events 24 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.9%
6/87 • Number of events 15 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
19.5%
17/87 • Number of events 27 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.2%
8/87 • Number of events 11 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.2%
8/87 • Number of events 10 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
8.0%
7/87 • Number of events 8 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.0%
20/87 • Number of events 30 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.3%
9/87 • Number of events 10 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
6/87 • Number of events 6 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Renal and urinary disorders
Haematuria
|
6.9%
6/87 • Number of events 11 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Renal and urinary disorders
Proteinuria
|
9.2%
8/87 • Number of events 8 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
7/87 • Number of events 7 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
10/87 • Number of events 11 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
|
Vascular disorders
Hypertension
|
5.7%
5/87 • Number of events 7 • Baseline Up To 100 Weeks
All participants who received at least one dose of study drug. Per protocol, Adverse Event analysis was planned as per treatment regimen received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60