Bristol Myers Squibb’s (BMJ) Phase III Relativity-098 trial examining its stage III-IV melanoma treatment, Opdualag, has failed to meet its primary endpoint of recurrence-free survival (RFS) over 52 months.
The randomised double-blind trial (NCT05002569) recruited 1,190 people across 184 international sites to determine the impact of adjuvant immunotherapy alongside Opdualag, its nivolumab and relatlimab fixed-dose combination designed to treat patients living with resected melanomas.
The trial compared the combination therapy against the company’s current standard of care (SoC) melanoma treatment nivolumab (Opdivo). While the primary endpoint sought to examine RFS, secondary endpoints sought to determine overall survival (OS) as well as the incidence of severe adverse events (SAE).
The treatment is designed to inhibit the formation of Lymphocyte-activation gene 3 (LAG-3), a molecule typically found on the surface of several immune cell types such as CD4+ and CD8+ T cells, preventing them from being fully able to attack potential tumours.
Jeffrey Walch, Opdualag global programme lead at BMJ, said: “We are disappointed in the outcome of the RELATIVITY-098 trial and that LAG-3 inhibition in the adjuvant setting did not lead to the same improved efficacy outcomes seen in advanced melanoma.
“Patients whose tumours are completely resected before treatment may not have sufficient antitumor T cells in place for Opdualag to have its maximal effect. However, Opdualag remains a SoC in the first-line treatment of unresectable or metastatic melanoma, and we continue to explore its potential across tumour types, including in non-small cell lung cancer.”
Research by GlobalData’s Pharmaceutical Intelligence Center found that in 2024, Opdualag brought in $928m for the company in its current indication of lung cancer alone. That figure is estimated to rise to more than $2.1bn by the end of 2030.
GlobalData is the parent company of Clinical Trials Arena.
In December 2023, BMS terminated Relativity-123, a trial that would have examined Opdualag in microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) after an independent examination concluded that it was unlikely to meet its primary endpoints.
Elsewhere in melanoma treatment, Evaxion Biotech has completed subject dosing in the Phase II trial of its personalised peptide-based cancer vaccine, EVX-01.
