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Cullinan Oncology Announces Clinical and Regulatory Update for CLN-081 in NSCLC EGFR Exon 20 Patients
Confirmed overall response rate improves to 41% at 100mg BID dose level Continued favorable safety and tolerability profile observed in heavily pre-treated
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"Confirmed overall response rate improves to 41% at 100mg BID dose level Continued favorable safety and tolerability profile observed in heavily pre-treated patients Pivotal study initiation expected 2H 2022 following food effect study CAMBRIDGE, Mass., March 28, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (Cullinan), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for cancer patients, today announced clinical and regulatory updates on its lead program, CLN-081. CLN-081 is being evaluated in an ongoing Phase 1/2a clinical trial in non-small cell lung cancer (NSCLC) patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations that have progressed on or after prior therapy. Clinical Update: In the ongoing Phase 1/2a study, CLN-081 was administered orally at dose levels including 30, 45, 65, 100 and 150 mg twice daily (BID). The most recent data now include 39 patients treated at 100 mg BID following the addition of 3 patients who were reassigned to receive the 100 mg BID dose after enrollment at 150 mg BID was discontinued. Key highlights at the 100 mg BID dose level: Of 39 response evaluable patients, 16 achieved a confirmed partial response for a 41% confirmed response rate. No patients have experienced Grade 3 or greater treatment-related diarrhea or rash. Promising response durability previously observed in initial phase 1 patient cohort (n=13) with estimated median response duration > 15 months and median progression free survival of 12 months. Cullinan expects to provide further data updates at medical conferences in 2022. Regulatory Update The Food and Drug Administration (FDA) recently granted CLN-081 Breakthrough Therapy Designation. Consistent with the FDA’s Project Optimus initiative regarding dose optimization, the FDA has encouraged Cullinan to explore the potential for a food effect on the clinical profile of the 150mg dose. In the ongoing Phase 1/2a trial, CLN-081 was administered under fasting conditions. The FDA has endorsed Cullinan’s plan to conduct a small food effect study (n~20) that is designed to evaluate the potential impact of food on exposure and other pharmacokinetic (PK) parameters at 150mg. Cullinan expects to initiate a pivotal study in the second half of 2022 following the completion of this PK food...