Cullinan, Taiho's Zipalertinib-Chemotherapy Combo Meets Key Goal in Phase 3 NSCLC Trial; Stock Up

What happened

The Phase 3 REZILIENT3 trial, evaluating zipalertinib plus platinum-based chemotherapy in the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), met its primary endpoint of progression-free survival (PFS) at an interim analysis. The trial enrolled 285 adults with previously untreated, EGFR exon 20 insertion-mutated non-squamous NSCLC. The study showed a statistically significant and clinically meaningful improvement in PFS in the zipalertinib-containing arm, with manageable safety. The Independent Data Monitoring Committee recommended unblinding the study, and full results will be submitted for presentation at an upcoming international medical conference. Following the news, Cullinan Therapeutics' stock (CGEM) rose 6.33% to $20.84 in after-hours trading, reaching a new 52-week high.

Why it matters

This positive Phase 3 result represents an important milestone for the zipalertinib program, as it may offer a new first-line treatment option for patients with EGFR exon 20 insertion mutations, a population with significant unmet need. The trial's success also boosted investor confidence, as reflected by the stock's rise to a new 52-week high.