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Aileron Therapeutics Announces Interim Data from Phase 1b Chemoprotection Trial of ALRN-6924 in Patients with p53-Mutated Non-Small Cell Lung Cancer (NSCLC) and Confirms Development Path for ALRN-6924 Focused on p53-Mutated Breast Cancer
Patients on ALRN-6924 were able to stay on treatment longer, completing more of the first 4 cycles of carboplatin/pemetrexed (93% of cycles on ALRN-6924
About this update from Rein Therapeutics, Inc.
[{"type":"text","content":"Patients on ALRN-6924 were able to stay on treatment longer, completing more of the first 4 cycles of carboplatin/pemetrexed (93% of cycles on ALRN-6924 versus 78% on placebo); this imbalance between treatment arms may have introduced a bias against ALRN-6924 on the composite primary endpoint Evaluating cycles 1-6, the imbalance increases further (79% of cycles on ALRN-6924 versus 57% on placebo) Interim finding on the trial’s composite primary endpoint, which was the proportion of treatment cycles free of Grade ≥3 neutropenia, anemia, thrombocytopenia, blood transfusions, use of growth factors, dose reductions/delays in the first 4 cycles, demonstrated 56% of cycles on ALRN-6924 versus 50% of cycles on placebo25 of the total 83 cycles completed across both treatment arms showed Grade ≥3 hematologic toxicities (30%); only 3 patients experienced Grade 4 hematologic toxicities in 6 of 83 cyclesAileron plans to stop further enrollment in the NSCLC trial, and to apply key learnings from the NSCLC data to strengthen the Phase 1b breast cancer trial in accordance with clinical and regulatory precedentsAileron to host webcast today at 8:00 am ET BOSTON, June 29, 2022 (GLOBE NEWSWIRE) -- Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, today announced interim data from its Phase 1b chemoprotection trial of patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. Aileron plans to stop further enrollment in the NSCLC trial and to apply key learnings from the interim analysis to strengthen the Phase 1b breast cancer trial in accordance with clinical and regulatory precedents. The interim analysis consisted of the first 20 patients randomized to ALRN-6924 0.3 mg/kg plus carboplatin/pemetrexed (n=11) or placebo plus carboplatin/pemetrexed (n=9).1,2 ALRN-6924-treated patients were able to stay on chemotherapy treatment longer, completing 93% of the first 4 cycles of carboplatin/pemetrexed administered compared to 78% on placebo.2,3 This imbalance of completed cycles between the treatment arms may have introduced a bias against ALRN-6924 on the composite primary endpoint. The imbalance increases further when looking at percentages o...