Zipalertinib Combo Cuts Risk of Progression by 50% in First-Line EGFR Exon 20 NSCLC
CGEM has more than doubled off its 52-week low of $5.68.
Summary
Full Phase 3 REZILIENT3 data show zipalertinib plus chemotherapy extended median progression-free survival to 14.5 months versus 8.5 months for chemo alone (HR=0.50, P=0.00015) in first-line EGFR exon 20 insertion NSCLC. Objective response rate was 65.0% vs 40.3% (P<0.0001), with a longer median duration of response (14.2 vs 9.9 months). Interim overall survival favored the combo (HR=0.72) but is immature at 30% events. Safety showed more Grade ≥3 AEs (87.1% vs 54.4%), driven by manageable hematologic toxicity. This follows the August 12 announcement that the trial met its primary endpoint; today's release provides the detailed dataset presented at WCLC. The magnitude of PFS benefit and response improvement supports a potential first-line label expansion, a key value driver for Cullinan's zipalertinib franchise.
At the time of this announcement, CGEM was trading at $21.11 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.3B. The 52-week trading range was $5.68 to $23.19. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.