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.
