Core Insights - Updated data indicates a consistent objective response rate (ORR) of 40% and a manageable safety profile for zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have progressed after prior amivantamab treatment [1][4] - The pivotal Phase 2b trial has completed enrollment ahead of schedule, originally planned for the end of 2024 [5] Clinical Trial Data - As of March 29, 2024, 45 patients were enrolled, with a median of three prior systemic anti-cancer regimens received [2] - Among 30 evaluable patients, 1 patient (3%) achieved a complete response (CR), 11 patients (37%) had a partial response (PR), and 15 patients (50%) had stable disease (SD) [3] - The confirmed ORR for Module C was 40%, compared to 41% in the previously reported Phase 1/2a results [4] Safety Profile - Zipalertinib demonstrated a manageable safety profile, with the most common treatment-related adverse events being rash (38%), paronychia (36%), anemia (24%), dry skin (20%), dermatitis acneiform (16%), nausea (16%), and stomatitis (11%) [4] Company and Product Overview - Zipalertinib is an orally available small molecule designed to target activating mutations in EGFR, specifically engineered to inhibit EGFR variants with exon 20 insertion mutations while sparing wild-type EGFR [8] - Cullinan Therapeutics has a partnership with Taiho, which includes an upfront cash payment of 130 million for U.S. regulatory milestones [7] - The company retains a 50/50 profit share in the U.S. for zipalertinib [7] Future Development - Cullinan and Taiho have a broad development program for zipalertinib, including ongoing pivotal studies in first-line and second-line NSCLC, as well as studies in other patient populations [6]
Cullinan Therapeutics Presents Positive Updated Data from Module C of Zipalertinib Pivotal Phase 2b Study at ESMO 2024