Taiho Oncology, Inc., and Cullinan Therapeutics, Inc. presented new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib at the IASLC 2025 World Conference on Lung Cancer on September 9, 2025. These data were shared as mini oral presentations during the "Common and Uncommon EGFR Mutations, New Treatments in the Horizon" session.
Updated data from the pivotal Phase 2b REZILIENT1 trial focused on 84 patients with NSCLC harboring EGFR ex20ins mutations who had been previously treated with amivantamab. With over 9 months of follow-up, zipalertinib demonstrated a manageable safety profile with no new safety signals. The most common treatment-emergent adverse events (TEAEs) included paronychia (41.7%), anemia (38.1%), and rash (34.5%).
Preliminary efficacy and safety results from the REZILIENT2 trial's uncommon non-ex20ins EGFR mutations cohort were also presented. This cohort included 40 patients, with 30% having a history of brain metastases. Zipalertinib 100 mg twice daily showed a manageable safety and tolerability profile, with common treatment-related adverse events (TRAEs) such as paronychia (47.5%), dermatitis acneiform (37.5%), and stomatitis (32.5%).
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