Taiho Pharmaceutical and Cullinan Therapeutics announced that their investigational EGFR inhibitor zipalertinib, combined with platinum-based chemotherapy, met the primary endpoint of progression-free survival (PFS) in the Phase 3 REZILIENT3 trial.
The global study evaluated the combination as a first-line treatment for adults with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Investigators randomized 285 patients to receive either zipalertinib plus platinum-based chemotherapy or chemotherapy alone.
According to the companies, the combination therapy produced a statistically significant improvement in PFS compared with chemotherapy alone during a planned interim analysis. The companies did not disclose the underlying PFS figures but described the benefit as clinically meaningful.
The safety profile of the investigational regimen was reported as manageable. Following the interim analysis, an independent data monitoring committee recommended that the study be unblinded. Investigators will continue to monitor both safety and efficacy.
Regulatory Plans Following Positive Trial Results
The companies said they plan to seek regulatory approval for the zipalertinib-chemotherapy combination in the first-line setting based on the REZILIENT3 findings.
In announcing the results, the partners stated that the study met its primary endpoint and that the treatment combination demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone.
The full results are expected to be presented at an upcoming medical conference.
FDA Review Already Underway in Previously Treated Disease
Zipalertinib is currently under review by the U.S. Food and Drug Administration as a monotherapy for patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The FDA accepted the application for review in April. A decision on that application is expected by Feb. 27 next year.
The latest Phase 3 outcome provides support for a potential filing seeking approval of zipalertinib in the first-line setting.
Market Landscape and Partnership Terms
If approved in the first-line setting, zipalertinib would enter a treatment area that already includes Johnson & Johnson’s Rybrevant, which received FDA approval for second-line use in 2021 and first-line use in 2024. Another approved therapy in the indication is Dizal Pharmaceutical’s Zegfrovy, which received FDA approval in 2025. AstraZeneca recently obtained exclusive global rights to Zegfrovy in a deal that included a $600 million upfront payment.
Taiho and Cullinan entered into their collaboration in 2022, when Taiho acquired a Cullinan subsidiary that housed zipalertinib for $275 million upfront.
Under the terms of the agreement, Cullinan is eligible to receive $30 million if zipalertinib is approved for second-line use and $100 million if it receives FDA approval in the first-line setting. The companies have also stated that Cullinan has the opportunity to receive up to $130 million in regulatory milestone payments. Taiho and Cullinan will split pretax profits from U.S. sales equally, while Taiho will be responsible for commercialization activities in the United States.
Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics announced that the Phase 3 REZILIENT3 trial of zipalertinib met its primary endpoint of progression-free survival at a planned interim analysis. The study evaluated zipalertinib plus platinum-based chemotherapy against chemotherapy alone in previously untreated patients with advanced non-small cell lung cancer carrying EGFR exon 20 insertion mutations.
The results represent an important development for Taiho, as the companies reported a statistically significant and clinically meaningful improvement in progression-free survival for the zipalertinib combination. Detailed efficacy figures have not yet been released.
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