Preliminary data from CLN-619 in combination with checkpoint inhibitor pembrolizumab show objective responses in patients with tumor types that are typically unresponsive to pembrolizumab, such as non-small cell lung cancer (NSCLC) with oncogenic mutations
Longer term follow-up for patients treated with CLN-619 monotherapy demonstrates durable clinical benefit across multiple tumor types
CLN-619 continues to demonstrate a favorable safety profile and is well tolerated both as monotherapy and in combination with pembrolizumab
Based on observed clinical activity, Cullinan has initiated additional monotherapy and combination therapy expansion cohorts in NSCLC
CAMBRIDGE, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced first clinical data from its Phase 1 dose escalation cohort of CLN-619 in combination with checkpoint inhibitor (CPI) pembrolizumab and updated results from the monotherapy dose escalation cohort in patients with advanced solid tumors. Findings from the clinical trial will be shared at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting as a poster presentation during the "Developmental Therapeutics—Immunotherapy" session (Abstract #2588, Poster Bd 67) on June 1, 2024, 9:00 AM-12:00 PM Central Time.
Summary of Key Clinical Results from Combination Arm of Phase 1 Clinical Trial in Patients with Solid Tumors
- Of 22 patients treated with CLN-619 in combination with pembrolizumab, 18 were RECIST-evaluable for response.
- Confirmed partial responses (PR) were observed in 3 patients treated with CLN-619 at doses ?3mg/kg in combination with pembrolizumab.
- Responses were observed in patients with tumor types not typically responsive to CPI treatment.
Characteristics of Responders
Tumor Type | Number of Prior Lines of Therapy | Prior CPI | CPI Responsive Tumor (Yes/No?) | Best Response | Duration of Response (Weeks) |
NSCLC, EGFR exon 18/21 | 6 | No | No | PR | 24 |
NSCLC, ALKr | 2 | No | No | PR | 12.7 |
Gastric, HER2+ | 3 | No |