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Sunday, June 1, 2025

Cullinan, Taiho Pivotal REZILIENT1 Phase 1 2 Data Published

Taiho Oncology and Cullinan Therapeutics (CGEM) announced positive Phase 1/2 REZILIENT1 trial results for zipalertinib in treating non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The study demonstrated significant efficacy with a 35.2% confirmed objective response rate across 176 patients, including those previously treated with amivantamab. The median duration of response was 8.8 months, with progression-free survival of 9.4 months. Notably, patients treated after platinum-based chemotherapy showed a 40% response rate. The drug showed promising results in patients with brain metastases (30.9% ORR) and maintained a manageable safety profile. The company is currently recruiting for the Phase 3 REZILIENT3 trial.

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