Multinational phase 2 study of first-line bempegaldesleukin plus nivolumab for metastatic melanoma

The multinational phase 2 PIVOT-02 study evaluated the combination of the CD122-preferential interleukin-2 pathway agonist bempegaldesleukin and nivolumab for previously untreated stage III or IV melanoma. The combination was tolerated, with relatively low rates of grade 3 and 4 treatment-related and immune-mediated adverse events. Blinded independent central review revealed objective response in 52.6% and complete response in 34.2% of the patients. The median PFS was 30.9 months and the median OS was not reached at median 29.0 months of follow-up (the 24-months OS was 77.0%).