Zipalertinib Shows 30% Intracranial Response Rate in Brain-Metastatic EGFR NSCLC
CGEM sits 98% above its 52-week low of $6.732.
Summary
Cullinan and partner Taiho reported first prospective data on zipalertinib's activity in the brain: among 43 evaluable patients with EGFR ex20ins or uncommon mutations and active CNS metastases, intracranial objective response rate was 30.2% and disease control 72.1%, with median intracranial duration of response of 9.7 months. In the 24 patients with no prior EGFR TKI exposure, intracranial response reached 37.5%. The cohort included 9 patients with leptomeningeal disease, a group with few options, and the drug was well tolerated with grade 3+ treatment-related events in 20.9%. This broadens the zipalertinib story beyond the REZILIENT3 frontline PFS win disclosed in August and September, adding a differentiated CNS claim ahead of the NDA submission initiated October 1 under the FDA's Real-Time Oncology Review. Full data will be presented at ESMO on October 26. The readout supports the commercial case for the franchise but does not change the near-term regulatory timeline already in motion.
At the time of this announcement, CGEM was trading at $13.35 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $832.1M. The 52-week trading range was $6.73 to $23.19. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.