Cullinan Therapeutics, Inc., in collaboration with Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc., announced on May 22, 2025, that new positive results from the pivotal Phase 2b cohorts of the REZILIENT1 trial would be presented. These data, concerning zipalertinib monotherapy in advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, were scheduled for an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1.
As of the December 2024 data cutoff, the overall efficacy population included 176 patients who received at least one dose of 100 mg zipalertinib, with a median follow-up of 9.3 months. The results demonstrated a manageable safety profile consistent with previously reported data in this heavily pre-treated patient population. Common treatment-related adverse events included paronychia (38.5%), rash (30.3%), and dermatitis acneiform (24.6%), with the majority being grade 1 or 2.
This presentation at ASCO 2025 is crucial for highlighting zipalertinib's potential to offer a meaningful oral treatment option for patients whose disease progressed after prior therapies. The findings from the REZILIENT1 trial support zipalertinib as a targeted therapy for a patient population with significant unmet medical needs.
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