Dr Spira on the Evaluation of Fianlimab Plus Cemiplimab in Advanced Melanoma

Alexander I. Spira, MD, PhD, FACP, co-director, Virginia Cancer Specialists Research Institute, director, Thoracic and Phase I Program, clinical assistant professor, Johns Hopkins School of Medicine, discusses the evaluation of the LAG-3 inhibitor fianlimab plus cemiplimab-rwlc (Libtayo) in patients with advanced melanoma who were PD-L1 inhibitor–naïve, as seen in the findings from a phase 1 study (NCT03005782).

This was a substantially sized trial with various expansion cohorts across multiple tumor types, including melanoma, Spira begins. The focus of this expansion study was on patients with advanced melanoma who were naïve to immunotherapy (IO), he states. The study comprised 3cohorts, the first of which included patients who had not previously received IO treatment but were permitted to have prior non-IO treatment, Spira explains. The second cohort consisted of patients who had not undergone prior systemic therapy, most of whom had BRAF V600E–mutant disease, he expands. The final cohort was made up of patients who would have otherwise received FDA-approved adjuvant systemic therapy, Spira notes, adding that thiscohort required patients to have a disease-free interval of at least 6 months.

This expansion trial had standard end points, with the primary end point being overall response rate (ORR), Spira expands. Notably, this trial also had typical secondary end points, such as progression-free survival, duration of response (DOR), disease control rate (DCR), safety, and pharmacokinetics, he explains. The preliminary results revealed an ORR of 61.2% among all patients enrolled in both the IO-naïve and systemic treatment–naïve arms. Within these cohorts, there were 12 complete responses and 48 partial responses, Spira says.

The DCR was 78%, the median DOR was not reached (95% CI, 23-not estimated [NE]), and the median PFS was 15.3 months (95% CI, 9.4-NE). In the subgroup of patients who had received prior neoadjuvant PD-1 therapy, the ORR rate was 61.5%, he explains. Overall, these data indicate that fianlimab plus cemiplimab is effective in different subgroups of patients with advanced melanoma, he concludes.