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Data demonstrate objective response rates from 56% to 63% across three independent cohorts of advanced melanoma patients – about double the rate historically seen with anti-PD-1 alone in similar settings – per trial results to be presented in an oral session at ASCO
Clinically meaningful responses observed in post hoc analyses of populations of interest, including patients with poor prognosis factors, prior anti-PD-1 therapy in the adjuvant setting and varying tumor PD-L1 expression levels
Pivotal Phase 3 trials in adjuvant and first-line advanced melanoma underway
TARRYTOWN, N.Y., May 25, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive data from three independent cohorts evaluating an investigational combination of LAG-3 inhibitor fianlimab and PD-1 inhibitor Libtayo® (cemiplimab) in adults with advanced melanoma. The early clinical trial results, which demonstrated the combination led to clinically meaningful and durable results across multiple clinical settings, will be shared in an oral session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago on Monday, June 5 at 3:00 PM CT.
“LAG-3 inhibitors are known to complement PD-1 inhibitors in the treatment of advanced melanoma. There exists an unmet need to further improve the benefit to patients, including those with liver metastases and other high-risk prognostic markers,” said Omid Hamid, M.D., Director, Clinical Research and Immunotherapy at The Angeles Clinic and Research Institute, and principal investigator of the trial. “These updated and independent expansion cohort results reinforce the potential of the fianlimab and cemiplimab (Libtayo) combination to deliver clinically meaningful and durable responses in diverse clinical settings and patient populations, with an acceptable safety profile. Particularly encouraging is that the clinical activity was observed in post hoc analyses of patient subgroups, including in patients with a poor prognosis or those who had been previously treated with an anti-PD-1 therapy in the adjuvant setting.”
The data to be presented at ASCO 2023 include findings from three independent expansion cohorts of adults with unresectable or metastatic melanoma who were all naïve to anti-PD-1 therapy for advanced disease (n=98). Additional follow up will be reported on an initial cohort of first- or second-line patients (n=40) and a confirmatory cohort of first-line patients (n=40), previously reported at ESMO 2022. New for this presentation is a cohort of patients who had received prior systemic treatment for melanoma in the neoadjuvant or adjuvant setting (n=18), including adjuvant anti-PD-1 therapy (n=13 of 18).
Tumor responses were based on RECIST 1.1 criteria and per investigator assessment. The median duration of response (DOR) was not reached in any cohort, and the objective response rate (ORR) by cohort was as follows:
In a post hoc analysis of the three combined cohorts, the ORR was 61% (60 of 98 patients), the median progression-free survival (PFS) was 15 months per Kaplan-Meier estimate (95% CI: 9–NE), and the median follow-up was 13 months (interquartile range 9-19). Additional post hoc analyses found clinically meaningful activity in multiple subgroups of interest, with ORRs in each as follows:
