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Cullinan Oncology to Present Updated Data Demonstrating the Therapeutic Potential of CLN-081 in Patients with EGFR Exon 20 Insertion Mutation Positive Non-Small Cell Lung Cancer at the 2022 ASCO Annual Meeting
Updated data from Phase 1/2a study show median duration of response greater than 21 months and median progression-free survival of 12 months at 100 mg BID
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"Updated data from Phase 1/2a study show median duration of response greater than 21 months and median progression-free survival of 12 months at 100 mg BID dose Confirmed overall response rate of 41% at 100 mg BID dose Continued favorable safety and tolerability profile observed in heavily pre-treated patients CAMBRIDGE, Mass., May 31, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for patients with cancer, today announced positive updated clinical research highlighting the therapeutic potential of CLN-081 in patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation positive non-small cell lung cancer (NSCLC). Findings will be presented on Friday, June 3 at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation during the “Lung Cancer – Non-Small Cell Metastatic” session from 4:12- 4:24 p.m. CT (Abstract #9007). CLN-081 is being evaluated in an ongoing Phase 1/2a clinical trial in patients with NSCLC whose tumors harbor EGFR exon 20 insertion mutations that have progressed on or after prior therapy. Summary of Key Clinical Results from Phase 1/2a Study of CLN-081 in NSCLC Patients with EGFR Exon 20 Insertion Mutations: As of May 2022, 73 patients have been treated across doses ranging from 30 to 150 mg twice daily (BID). Of the patients enrolled, 66% of patients had received two or more prior lines of treatment; 36% of patients had prior EGFR tyrosine kinase inhibitor (TKI) treatment, 55% of patients had received prior immunotherapy. Among the 73 patients treated across all dose levels, 28 (38%) had confirmed partial response, 42 (58%) had stable disease and 3 (4%) had progressive disease according to RECIST guidelines (version 1.1). Of the 39 patients in the 100 mg BID dose group: 16 (41%) had a confirmed partial response.The estimated median duration of response (DOR) was greater than 21 months.Median progression-free survival (PFS) was 12 months. The safety profile of CLN-081 was amenable for long-term treatment. The most common treatment-related adverse events in greater than 10% of patients were rash (80%), paronychia (32%), diarrhea (30%), fatigue (21%), anemia (19%), dry skin (18%), and nausea (16%), the majority of which were Grade 1/2. No Grade ≥3 ra...