Bristol Myers Squibb has halted its phase 3 RELATIVITY-123 trial, assessing the Opdivo (nivolumab) and relatlimab, a LAG-3-blocking antibody, combination for microsatellite stable metastatic colorectal cancer.
The decision, based on an independent data monitoring committee's analysis, was due to futility in meeting primary endpoints. The company will continue investigating the combination against other tumor types.
In March 2022, the FDA approved the Opdivo-relatlimab fixed-dose combo, branded Opdualag, for patients with unresectable or metastatic melanoma.
Opdivo, which was first approved in late 2014 for melanoma, was the first PD-1 immune checkpoint inhibitor to receive regulatory approval. Now one of the top-selling drugs in the world, Opdivo and Opdivo-based combinations have demonstrated mixed effectiveness in treatments for several tumor types, including bladder cancer and melanoma.
In 2018, an Opdivo-Yervoy combo was approved by the FDA as the first immuno-oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced kidney cancer. In 2020, the combo was approved to treat patients with hepatocellular carcinoma, the most common type of liver cancer.