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Cullinan Oncology Announces Phase 1/2a Interim Data For Cullinan Pearl’s CLN-081 in NSCLC EGFR Exon 20 Patients
CLN-081 Continues to Demonstrate Acceptable Overall Safety and Tolerability, With Encouraging GI Toxicity ProfileAs of the Data Cutoff, No Grade 3 TRAE
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"CLN-081 Continues to Demonstrate Acceptable Overall Safety and Tolerability, With Encouraging GI Toxicity ProfileAs of the Data Cutoff, No Grade 3 TRAE Diarrhea at Doses Below 150mg BID; No Grade 3 Rash TRAEsObjective Responses Were Observed Across the Dose Range, with a Confirmed Objective Response Rate of 46% in Patients Treated at 100 mg BID Phase 2a Expansion Initiated at 100 mg BID CAMBRIDGE, Mass., June 04, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM) (“Cullinan”), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced additional details pertaining to Cullinan Pearl’s ongoing Phase 1/2a trial of CLN-081 in Non-Small Cell Lung Cancer (NSCLC) patients whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations. CLN-081 is an orally available, irreversible EGFR inhibitor, utilizing a unique pyrrolopyrimidine scaffold that was designed to selectively target cells expressing mutant EGFR variants, including exon 20, while sparing cells expressing wild type (WT) EGFR. These data will be featured in an on-demand poster presentation available this morning at 9:00 am EDT at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and during a company sponsored webinar at 10:30 am EDT today, which can be accessed here or in the ‘Events’ section on Cullinan’s investor website. “We remain encouraged with CLN-081's emerging profile,” stated Owen Hughes, Cullinan’s Chief Executive Officer. “In heavily pretreated patients, CLN-081 continues to show antitumor activity across the dose range, with a safety profile that appears to be differentiated, most specifically with respect to GI adverse events.” The current analysis of the ongoing trial evaluated a total of 45 NSCLC patients with EGFR exon 20 insertion mutations who received at least one dose of CLN-081 as of the April 1, 2021, data cutoff, and were evaluable for safety. CLN-081 was dosed orally, at dose levels including 30, 45, 65, 100 and 150 mg twice daily (BID). As of the data cutoff, 42 of 45 patients were response evaluable across all dose cohorts tested. Overall Safety: Regarding treatment related adverse events (TRAEs) associated with WT EGFR inhibition: Rash has been limited to Grade 1 and 2 events (76% of patients experienced an event across all doses as of the data cutoff...