A Bristol Myers Squibb immunotherapy currently approved as a first-line treatment for metastatic melanoma has failed a pivotal clinical trial intended to support expanding the therapy’s use to keeping this cancer from coming back.
The Phase 3 study enrolled patients whose stage III to IV melanoma was completely removed surgically. Participants were dosed with the study drug, Opdualag, in combination with nivolumab (brand name Opdivo), a different BMS immunotherapy that’s already approved for use in this adjuvant setting. BMS said after Thursday’s market close that the Opdualag and Opdivo combination did not meet the main goal of recurrence-free survival compared with Opdivo as a monotherapy.
Opdualag and Opdivo are both checkpoint inhibitors, drugs that block proteins that tumors use to avoid detection by the immune system. Whereas Opdivo blocks the checkpoint protein PD-1 on T cells, Opdualag blocks a different checkpoint protein called LAG-3. In 2022, the FDA approved Opdualag as a treatment for advanced cases of melanoma, making the immunotherapy the first LAG-3 inhibitor to pass regulatory muster. For this indication, Opdualag is approved for use alongside Opdivo.
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In the adjuvant setting, the hope was the pairing of Opdualag and Opdivo would prevent a recurrence of melanoma following surgery. BMS said safety in this study was in line with prior clinical tests of Opdualag and Opdivo. Specific details about the clinical study results were not released, but Jeffrey Walch, vice president, Opdualag global program lead at BMS, offered a possible explanation for the trial failure.
“Patients whose tumors are completely resected before treatment may not have sufficient antitumor T cells in place for Opdualag to have its maximal effect,” Walch said in a prepared statement. “However, Opdualag remains a standard of care in the first-line treatment of unresectable or metastatic melanoma, and we continue to explore its potential across tumor types, including in non-small cell lung cancer.”
Opdualag generated $928 million in revenue in 2024, up 48% from the prior year. Opdivo is BMS’s top cancer product, accounting for $9.3 billion in sales last year. But Opdivo’s patent will expire in 2028. BMS is looking to grow revenue on multiple fronts as several key products face patent expiration in coming years.
The adjuvant setting in melanoma is a large market — twice the size of the market for first-line metastatic melanoma, Leerink Partners analyst David Risinger wrote in a research note. Despite Opdualag’s failure in the adjuvant study, Leerink still expects Opdualag will become a blockbuster product, reaching an estimated $1.9 billion in peak sales in 2028. But Risinger noted that this estimate is 30% below the consensus peak sales estimate of $2.6 billion in 2035, due to expected competitive pressure from fianlimab, a LAG-3 antibody in development by Regeneron Pharmaceuticals. Fianlimab is in late-stage development as a first-line treatment for metastatic melanoma and as an adjuvant treatment for melanoma.
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Public domain image by Julio C. Valencia via the National Cancer Institute