Cullinan Therapeutics Announces Positive Initial Data from Pivotal Phase 2b REZILIENT1 Study of Zipalertinib

Core Insights - Cullinan Therapeutics announced positive initial data for zipalertinib in patients previously treated with amivantamab in the pivotal Phase 2b REZILIENT1 clinical trial [1][4] - The drug demonstrated promising efficacy and a manageable safety profile, comparable to results seen in patients who progressed after platinum-based chemotherapy [4][5] Patient Data and Efficacy - As of January 12, 2024, 31 patients were enrolled, with a median of three prior systemic anti-cancer regimens [2] - Among 18 evaluable patients, the objective response rate (ORR) was 39%, and the disease control rate (DCR) was 94%, similar to the Phase 1/2a results where ORR was 41% and DCR was 97% [3] Safety Profile - Zipalertinib exhibited a manageable safety profile, with no grade 4 or grade 5 treatment-related adverse events reported [3] Development and Partnerships - The company has a comprehensive development plan for zipalertinib, which includes ongoing pivotal studies in first-line and second-line treatment for non-small cell lung cancer (NSCLC) [4][5] - Cullinan entered a partnership with Taiho in 2022, involving an upfront payment of $275 million and additional payments totaling$130 million for regulatory approvals in the U.S. [4] Future Plans - Enrollment for the pivotal Phase 1/2b REZILIENT1 trial is expected to be completed by the end of 2024 [5] - An investor event is scheduled to present the zipalertinib data, indicating ongoing engagement with stakeholders [6][7]