Phase 3 trial of combination for advanced melanoma misses primary endpoints

Source: Healio, March 2022

A phase 3 trial designed to assess the addition of bempegaldesleukin to nivolumab for previously untreated unresectable or metastatic melanoma failed to meet its primary endpoint, according to the agents’ manufacturers.

The combination failed to improve PFS or objective response rates as assessed by blinded central review, according to results from the first analysis of the phase 3 PIVOT IO-001 study.

In addition, the trial did not meet the third primary endpoint of improved OS at the first interim analysis.