Cullinan zipalertinib improves PFS by six months

• Cullinan Therapeutics (NASDAQ:CGEM) and Taiho reported a six-month median PFS improvement with zipalertinib plus chemotherapy versus chemotherapy alone.
• The Phase 3 REZILIENT3 trial produced a PFS hazard ratio of 0.50, representing a 50% lower risk of disease progression or death.
• The companies said the results support zipalertinib plus chemotherapy as a potential first-line treatment for EGFR exon 20 insertion-mutated NSCLC.

Cullinan Therapeutics (NASDAQ:CGEM), Taiho Oncology, and Taiho Pharmaceutical reported that zipalertinib plus chemotherapy improved median progression-free survival by six months versus chemotherapy alone in the Phase 3 REZILIENT3 trial.

The first-line combination reduced the risk of disease progression or death by 50%, with a hazard ratio of 0.50, a 95% confidence interval of 0.34 to 0.73, and P=0.00015.

“The combination also produced significantly higher response rates compared with chemotherapy alone,” said REZILIENT3 investigator Helena A. Yu.

The study evaluated zipalertinib plus platinum-based chemotherapy in patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations and met its primary progression-free survival endpoint.

At the planned interim overall survival analysis with 30% event maturity, the hazard ratio for death was 0.72 with a 95% confidence interval of 0.42 to 1.23, with follow-up continuing.

The companies said the trial also showed improvements in response rates and duration of response, adding to previously reported data evaluating zipalertinib as a single agent.

Taiho and Cullinan said they plan to discuss the REZILIENT3 findings with health authorities as they evaluate potential regulatory steps for zipalertinib in the first-line setting.