Advanced Melanoma: Efficacy of Monoclonal Antibody Doublet
Source: The Asco Post, July 2024
In a phase I trial reported in the Journal of Clinical Oncology, Omid Hamid, MD, and colleagues found that the combination of the human lymphocyte activation gene-3 (LAG-3)-targeting monoclonal antibody fianlimab plus the PD-1–targeting monoclonal antibody cemiplimab-rwlc was active in patients with advanced melanoma.
Study Details
In the study, 113 patients from sites in the United States, United Kingdom, Ireland, South Korea, and Australia were allocated to four expansion cohorts between October 2018 and April 2022. The four cohorts consisted of an anti–PD-1–naive cohort (n =40), a systemic treatment–naive cohort (n = 40), a previous neoadjuvant/adjuvant treatment cohort (n = 18), and a previous anti–PD-1 therapy for advanced disease cohort (n = 15). Patients received fianlimab at 1,600 mg and cemiplimab at 350 mg once every 3 weeks for up to 51 weeks, with an optional additional 51 weeks if clinically indicated. The primary outcome measure of the study was objective response.
Key Findings
Objective response rates were 63% in the anti–PD-1-naive cohort (median follow-up = 20.8 months); 63% in the systemic treatment–naive cohort (median follow-up = 11.5 months); 56% in the previous neoadjuvant/adjuvant treatment cohort (median follow-up = 11.5 months); and 13% in the previous anti–PD-1 therapy for advanced disease cohort (median follow-up = 8 months). At a median follow-up of 12.6 months for the combined three cohorts who had not received previous anti–PD-1 therapy for advanced disease, the objective response rate was 61.2% and median progression-free survival was 13.3 months (95% confidence interval [CI] = 7.5 months to not evaluable).