Dr. Tawbi on the FDA Approval of Relatlimab/Nivolumab in Unresectable or Metastatic Melanoma

Hussein A. Tawbi, MD, PhD, director of Melanoma Clinical Research and Early Drug Development and Personalized Cancer Therapy, deputy chair and professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the FDA approval of relatlimab plus nivolumab (Opdualag) in unresectable or metastatic melanoma.

On March 18, 2022, the FDA approved the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma. The approval opens the door to increased benefit from checkpoint inhibitors, Tawbi says.

The decision is based on findings from the phase 2/3 RELATIVITY-047 trial (NCT03470922), which demonstrated that the combination more than doubled median progression-free survival (PFS) per blinded independent central review vs nivolumab alone as frontline treatment in patients with advanced melanoma.

Results from the study, which were updated at the March 2022 ASCO Plenary Series, demonstrated a median PFS of 10.22 months (95% CI, 6.51-14.75) with the combination vs 4.63 months (95% CI, 3.48-6.44) with nivolumab alone (HR, 0.78; 95% CI, 0.64-0.94). The 12-month PFS rate with the combination was 48.0% (95% CI, 42.5%-53.4%) vs 36.9% (95% CI, 31.7%-42.1%) with nivolumab alone. Moreover, the PFS benefit with the combination was seen across prespecified subgroups and stratification factors.

In terms of safety, the rate of grade 3/4 treatment-related adverse effects (TRAEs) was 21.1% with the combination vs 11.1% with nivolumab alone, which compares favorably with the rate of grade 3/4 TRAEs with the combination of ipilimumab (Yervoy) and nivolumab in the phase 3 CheckMate-067 trial (NCT01844505; 59%). Ultimately, the combination represents a good option that is better tolerated than ipilimumab plus nivolumab and more effective than nivolumab alone, Tawbi concludes.