On January 28, 2025, Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc. announced that the REZILIENT1 trial met its primary endpoint of overall response rate. This Phase 1/2 clinical trial evaluated zipalertinib monotherapy in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who had received prior therapy.
The results, based on the Phase 2b portion of the study, indicated a safety profile generally consistent with previous data presentations. Zipalertinib, an orally available small molecule, is designed to selectively target activating mutations in EGFR, specifically exon 20 insertion mutations, while sparing wild-type EGFR.
This pivotal milestone paves the way for future regulatory action. Pending discussions with the U.S. Food and Drug Administration (FDA), the companies plan to submit for U.S. regulatory approval in the second half of 2025. Zipalertinib has previously received Breakthrough Therapy Designation from the FDA, underscoring its potential to address a significant unmet medical need.
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