A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

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.

Time frame: 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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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.

PK: AUC\[0-tlast\] of LOXO-305

Time frame: 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

Time frame: 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.