Cullinan reports Phase 2b zipalertinib data: 39% ORR in post-amivantamab NSCLC patients

Cullinan Therapeutics, Inc.

ORR of 39% (confirmed) and DCR of 94% in 18 evaluable patients; median DOR and PFS not yet reached.
No grade 4 or 5 treatment-related adverse events; safety profile manageable and consistent with prior data.
Data cut-off Jan 12, 2024; patients received median 3 prior therapies including chemo, anti-PD1/L1, and EGFR TKI.
Enrollment in pivotal REZILIENT1 trial (Modules B2 and C) on track to complete by end of 2024.
Partnership with Taiho: upfront $275M plus up to $130M in milestones; 50/50 US profit share.

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