Regeneron to highlight progress across oncology portfolio, pipeline

Regeneron Pharmaceuticals announced the presentation of data from its oncology portfolio at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer and the European Society for Medical Oncology Annual Meeting. A combined 11 presentations across both congresses highlight Regeneron’s commitment to transforming care for people living with difficult-to-treat cancers, including advanced melanoma, advanced non-melanoma skin cancer, and different types of lung cancer. Notably, at ESMO, Regeneron will present new, two-year results evaluating the investigational combination of LAG-3 inhibitor fianlimab and Libtayo in adults with advanced melanoma across three independent expansion cohorts of a first-in-human, multi-cohort trial. The combination is being further studied in an ongoing, randomized, placebo-controlled, blinded Phase 3 trial of fianlimab and Libtayo versus pembrolizumab in previously untreated unresectable locally advanced or metastatic melanoma. Additional trials are underway in the adjuvant and perioperative settings, as well as against other first-line, standard-of-care LAG3 and PD-1 combinations. The longer-term analysis of 98 patients from the initial trial builds on results presented at ASCO 2023, with data assessed per blinded independent central review presented for the first time. With a median follow-up of 23 months and median treatment duration of 35 weeks, the results show persistent and deepening tumor responses across all three independent cohorts. Results were as follows: In MM1, the initial cohort, there was a 23% complete response rate and a 60% objective response rate/ In MM2, the confirmatory cohort, there was a 25% CR rate and a 63% ORR. In MM3, the cohort of patients with prior neoadjuvant or adjuvant systemic therapy there was a 28% CR rate and a 39% ORR. In a post-hoc analysis of the three cohorts combined, there was a 25% CR rate and a 57% ORR. Initial progression-free survival and overall survival assessments from this single arm trial, which support the ongoing Phase 3 trial designed to evaluate these survival endpoints for the Libtayo and fianlimab combination, were as follows: PFS for the MM1, MM2, and MM3 cohorts, respectively: Not reached, 19 months, and 12 months. In a post-hoc analysis of the three cohorts combined, median PFS was 24 months and median OS was not reached. Median OS was also not reached for any individual cohort. Additional analyses on difficult-to-treat subgroups, including patients who had received prior adjuvant anti-PD-1 therapy, will be presented. The safety profile of the fianlimab and Libtayo combination was generally consistent with the safety profile of Libtayo monotherapy and other anti-PD-(L)1 agents, except for higher rates of treatment-related adrenal insufficiency. Adverse events of any grade occurred in 95% of patients. Grade 3 or greater AEs, serious AEs, and immune-mediated AEs occurred in 47%, 36%, and 13% of patients, respectively. AEs leading to death occurred in seven patients; two were considered treatment related.