Cullinan Oncology Posts Updated Data for CLN-081 in NSCLC EGFR Exon 20 Patients

Cullinan Oncology Inc CGEM reported updated data from its ongoing Phase 1/2a trial of CLN-081 in non-small cell lung cancer (NSCLC) patients.

• The trial includes patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations that have progressed on or after prior therapy.
• CLN-081 was administered orally, at dose levels including 30, 45, 65, 100, and 150 mg twice daily (BID). 
• 100mg BID was nominated as the Recommended Phase 2 Dose (RP2D) for CLN-081.
• Of 36 response evaluable patients, 14 achieved a confirmed partial response (PR) for a 39% confirmed response rate. One additional patient had a PR that was pending confirmation at the time of the data cut-off.
• The median duration of response was over 15 months, and the median progression-free survival was 12 months in the initial cohort of phase 1 patients (N=13).
• On the safety front, mild to moderate rash and diarrhea were observed that were manageable with conventional supportive care. No patients experienced Grade 3 or greater treatment-related rash.
• No prophylactic regimen has been required to ameliorate the incidence or severity of diarrhea to date.
• Price Action: CGEM shares are down 1.44% at $15.70 during the market session on the last check Thursday.