Cullinan's zipalertinib meets primary endpoint in Phase 2b NSCLC trial; H2 2025 FDA submission planned

Cullinan Therapeutics, Inc.

REZILIENT1 trial met primary endpoint of overall response rate in NSCLC with EGFR exon 20 insertion mutations after prior therapy.
Safety profile generally consistent with previous data presentations; full results to be submitted for upcoming medical conference.
Pending FDA discussions, companies plan to submit for U.S. regulatory approval in second half of 2025.
Zipalertinib (CLN-081/TAS6417) is a monotherapy for patients who have received prior therapy.

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