A Global Multicenter, Open Label, Randomized, Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic Phase Chronic Myeloid Leukemia (POLARIS-2)

Chronic Phase Chronic Myeloid Leukemia

Part A: MMR rate at 24 weeks, Part B: MMR rate by 24 weeks

Part A: MMR rate at 96 weeks, Part A: Cytogenetic response rate (complete, partial, major, minor, minimal, no response) at and by all scheduled data collection time points, including 24, 48 and 96 weeks, Part A: MMR, MR4, MR4.5 rate at all scheduled data collection time points (except 24 and 96 weeks which are already covered by primary and key secondary endpoints), Part A: MMR, MR4, MR4.5 rate by all scheduled data collection time points including 24, 48 and 96 weeks, Part A: Time to MMR, MR4, MR4.5, Part A: Duration of MMR, MR4, MR4.5, Part A: Time to complete cytogenetic response (CCyR), Part A: Duration of CCyR, Part A: Time to treatment failure, Part A: Progression free survival, Part A: OS, Part A: Type, frequency, and severity of adverse events, Part A:Changes in laboratory values that fall outside the normal ranges and clinically notable ECG and other safety data (vital signs, physical examination), Part A:Trough plasma concentration; key PK parameters including apparent clearance, apparent volume of distribution and other appropriate parameters, Part A: Change in health utility from baseline over time according to EQ-5D-5L, Part A: Change in work productivity and activity impairment over time according to EORTC QLQ-C30, Part B: MMR rate by 96 weeks, Part B:Cytogenetic response rate (complete, partial, major, minor, minimal, no response) by all scheduled data collection time points, including 24, 48 and 96 weeks, Part B:MMR, MR4, MR4.5 rate by all scheduled data collection time points (except 24 and 96 weeks, which are already covered by primary and key secondary endpoints), Part B:Time to MMR, MR4, MR4.5, Part B:Duration of MMR, MR4, MR4.5, Part B:Time to CCyR, Part B:Duration of CCyR, Part B: Time to treatment failure, Part B:Progression free survival, Part B:OS, Part B:Type, frequency, and severity of adverse events., Part B:Changes in laboratory values that fall outside the normal ranges and clinically notable ECG and other safety data (vital signs, physical examination), Part B:Trough plasma concentration; key PK parameters including apparent clearance, apparent volume of distribution and other appropriate parameters, Part B:Change in health utility from baseline over time according to EQ-5D-5L, Part B:Change in work productivity and activity impairment over time according to EORTC QLQC30

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