Cullinan-Taiho eye FDA filing for zipalertinib after trial shows strong PFS benefit despite three deaths

Cullinan Therapeutics and its partner Taiho Oncology said they will seek FDA approval for zipalertinib, an oral therapy for a subset of non‑small cell lung cancer, based on data from a late‑stage study.

In the Phase 3 REZILIENT3 trial, 280 patients with advanced non‑squamous NSCLC harboring EGFR exon 20 mutations were randomized to receive zipalertinib plus chemotherapy or chemotherapy alone. The combination cut the risk of disease progression by roughly 50 percent, delivering a notable improvement in progression‑free survival.

The study also reported three deaths from septic shock, raising safety concerns. Analysts noted that the strong survival benefit and planned risk‑mitigation strategies could outweigh these events as the drug moves toward market approval.