Cullinan Oncology Lead Cancer Program Shows Confirmed ORR Of 41% In Lung Cancer Setting

Cullinan Oncology Inc (NASDAQ: CGEM) announced clinical and regulatory updates from Phase 1/2a trial of CLN-081 in a non-small cell lung cancer (NSCLC) setting.

• The trial includes NSCLC patients harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations progressed on or after prior therapy.
• 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.
• Of the 39 response evaluable patients, 16 achieved a confirmed partial response for a 41% confirmed overall response rate (ORR).
• Related: Cullinan Oncology Posts Updated Data for CLN-081 in NSCLC EGFR Exon 20 Patients.
• No patients have experienced Grade 3 or greater treatment-related diarrhea or rash.
• Additionally, the FDA has encouraged Cullinan to explore the potential for a food effect on the clinical profile of the 150mg dose. 
• The agency has endorsed Cullinan's plan to conduct a small food effect study (n~20) designed to evaluate food's potential impact on exposure and other pharmacokinetic (PK) parameters at 150mg. 
• Cullinan expects to initiate a pivotal study in 2H of 2022 following the completion of this PK food effect study.
• Price Action: CGEM shares closed 2.44% lower at $11.20 on Monday.