Dr McKean on the Efficacy of Fianlimab Plus Cemiplimab in Advanced Melanoma

Meredith McKean, MD, executive committee chair, Melanoma and Skin Cancer Research Program, executive committee chair, BRIDGE Program, Sarah Cannon Research Institute, discusses the rationale for combining fianlimab with cemiplimab-rwlc (Libtayo) in the treatment of patients with advanced melanoma and highlights long-term follow-up data with the combination. Notably, these phase 1 trial (NCT03005782) data were shared at the 2024 ESMO Congress.

This open-label, nonrandomized, multi-cohort expansion study enrolled adult patients with metastatic or locally advanced, inoperable non-uveal melanoma. This clinical trial was a multi-cohort expansion study that included various tumor types, with a specific focus on 3 cohorts of patients with metastatic melanoma, McKean begins. The first cohort comprised 40 patients treated in either the first or second-line metastatic setting, none of whom had previously received anti–PD(L)-1 therapy, she explains. The second cohort involved an additional 40 patients treated in the frontline setting, who were also anti–PD-1 inhibitor naïve, McKean says, adding that the third cohort included 18 patients who had received prior neoadjuvant or adjuvant therapy but later developed metastatic melanoma. All patients were treated with fianlimab at 1600 mg and cemiplimab at 350 mg every 3 weeks for up to 24 months, and the primary end point of the study was objective response rate (ORR).

At the ESMO Congress, updated data with a 23-month median follow-up (interquartile range, 15-31) for all 3 cohorts were presented, she continues. The results revealed an ORR of 57% (95% CI 47%-67%), with deep and durable responses observed across the cohorts. Notably, the complete response rate increased to 25%, indicating asignificant improvement in outcomes for patients compared with previously reported data, McKean reports. These findings highlight the potential of this treatment approach in achieving long-lasting responses in metastatic melanoma, particularly in patients who have not previously received anti–PD-1 therapy, she says. The durable nature of the responses across the cohorts offers encouraging insights into the efficacy of this therapeutic strategy for a challenging-to-treat patient population, McKean concludes.