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Taiho Oncology and Cullinan Therapeutics Announce Pivotal REZILIENT1 Phase 1/2 Data Published in the Journal of Clinical Oncology

Taiho Oncology and Cullinan Therapeutics published positive Phase 1/2 REZILIENT1 trial results on June 2, 2025, in the Journal of Clinical Oncology.
The trial enrolled 176 adult patients with recurrent or metastatic non-small cell lung cancer characterized by EGFR exon 20 insertion mutations, all of whom had previously received treatments such as platinum-based chemotherapy and amivantamab.
Zipalertinib showed a confirmed overall objective response rate of 35.2%, median response duration of 8.8 months, and progression-free survival of 9.4 months in this population.
Among individuals who received zipalertinib following only platinum-based chemotherapy , the overall response rate was 40% with a median duration of response of 8.8 months; in a subgroup of those with brain metastases, the confirmed response rate was 30.9% with a median duration of 8.3 months.
Zipalertinib remains investigational but has FDA Breakthrough Therapy Designation, and ongoing Phase 3 REZILIENT3 recruitment aims to confirm its clinical benefit in this setting.

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Taiho Oncology and Cullinan Therapeutics Announce Pivotal REZILIENT1 Phase 1/2 Data Published in the Journal of Clinical Oncology

PRINCETON, N.J. and CAMBRIDGE, Mass., June 1, 2025 /PRNewswire/ -- Taiho Oncology, Inc., and Cullinan Therapeutics, Inc., announced today the publication of positive results from the REZILIENT1 trial in the peer-reviewed Journal of Clinical Oncology (JCO). REZILIENT1 is a Phase…

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