Cullinan initiates FDA filing for lung cancer drug zipalertinib

Cullinan Therapeutics (CGEM) submitted an NDA for zipalertinib plus platinum chemo in first-line EGFR exon 20 insertion NSCLC, based on Phase 3 REZILIENT3 meeting its primary endpoint. The company expects to complete the NDA by year-end 2026, according to the press release.

Cullinan Therapeutics (CGEM) initiated NDA submission for zipalertinib plus chemotherapy in first-line EGFR exon20ins NSCLC under FDA's RTOR program, with completion expected by year-end 2026. The submission follows positive Phase 3 REZILIENT3 trial results, showing significant improvement in progression-free survival. Zipalertinib has FDA Breakthrough Therapy designation, and Cullinan may receive $100M in milestone payments upon approval.

Cullinan Therapeutics (CGEM) shares fell 5% after delaying rheumatoid arthritis data to December, later than expected. The company also faces safety concerns about zipalertinib. Cullinan plans to present data on other drugs at upcoming conferences. TD Cowen maintains a Buy rating, citing potential catalysts. CGEM stock is up 55% year-to-date.

Cullinan Therapeutics (CGEM) reported Phase 3 REZILIENT3 results, showing zipalertinib plus chemotherapy achieved 14.5 months median PFS vs. 8.5 months for chemotherapy alone in NSCLC patients. While efficacy is promising, high adverse event rates raise toxicity concerns. The company shares U.S. profits with Taiho Pharmaceutical.

Cullinan Therapeutics (CGEM) shares fell 6.3% despite positive Phase 3 trial results for zipalertinib in lung cancer treatment. The REZILIENT3 trial met its primary endpoint, showing a 6.0-month improvement in median progression-free survival compared to chemotherapy alone. The company plans to discuss the results with health authorities. According to Cullinan, the trial enrolled 279 patients with advanced NSCLC.

Cullinan Therapeutics reported that its drug zipalertinib, combined with chemotherapy, showed a median progression-free survival of 14.5 months compared to 8.5 months with chemotherapy alone in the Phase 3 REZILIENT3 trial. The study included 279 patients with EGFR ex20ins NSCLC. The combination also achieved a higher objective response rate (65.0% vs. 40.3%) and longer median duration of response (14.2 vs. 9.9 months). Safety data showed higher Grade ≥3 adverse events with the combination, prim