Tokyo’s Taiho and Cullinan Announce Positive Phase 3 Lung Cancer Results

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

Cullinan Therapeutics' Zipalertinib plus chemotherapy improved progression-free survival and response rates in first-line EGFR exon 20 insertion mutation NSCLC, according to the company. The treatment showed a manageable safety profile, supporting its potential as a first-line option.

Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics reported Phase 3 REZILIENT3 trial results, showing zipalertinib plus chemotherapy improved progression-free survival in EGFR exon 20 insertion mutation NSCLC patients. Median PFS increased by 6.0 months (HR=0.50). The companies view zipalertinib as a key growth driver, though earnings forecasts remain unchanged.

Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics (CGEM) reported positive Phase 3 trial results for zipalertinib plus chemotherapy in lung cancer. The combination improved progression-free survival by 6.0 months (14.5 vs. 8.5 months) with a hazard ratio of 0.50. The trial enrolled 279 patients, with objective response rates of 65.0% for the combination vs. 40.3% for chemotherapy alone. Zipalertinib is not yet approved.