Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer

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.

Cullinan Therapeutics (CGEM) announced positive interim results from its Phase 3 REZILIENT3 trial of Zipalertinib for EGFR exon 20 insertion mutation-positive NSCLC. The trial met its primary endpoint of progression-free survival. Data will be presented at IASLC 2026. CGEM had $356.0M in cash as of Q2 2026. The stock closed at $21.00, down 1.45%.

Cullinan Therapeutics (CGEM) will present Phase 3 REZILIENT3 trial data on zipalertinib plus chemotherapy for NSCLC at WCLC 2026. The trial met its primary endpoint of progression-free survival. The company will host an investor event on September 14, 2026, to discuss the results.

Cullinan Therapeutics (CGEM) shares rose 6.6% after positive Phase 3 trial results for zipalertinib in lung cancer. The trial met its primary endpoint, showing significant progression-free survival benefits. This positions zipalertinib as a potential first-line treatment for a specific subset of non-small cell lung cancer patients, supporting planned U.S. regulatory filings. Cullinan Therapeutics has no revenue but holds a high-risk pipeline with potential in oncology and autoimmune diseases.

Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics (CGEM) reported positive Phase 3 trial results for zipalertinib in lung cancer. The trial met its primary endpoint, showing significant improvement in progression-free survival for patients with EGFR exon 20 insertion mutations. The companies plan to submit full results for presentation at an upcoming medical conference and pursue U.S. regulatory approval. Zipalertinib would compete with Johnson & Johnson's amivantamab (Rybrevant) i

Taiho Oncology and Cullinan Therapeutics (CGEM) announced that Phase 3 REZILIENT3 trial data for zipalertinib plus chemotherapy in EGFR exon 20 insertion mutation NSCLC will be presented at the 2026 IASLC World Conference. The trial met its primary endpoint of progression-free survival. Zipalertinib is an investigational EGFR inhibitor.