BMS’ Phase III Opdualag Melanoma Fail Could Limit Market Opportunity: Analysts

Pictured: BMS sign on a building in San Diego, California/iStock, JHVEPhoto

iStock, JHVEPhoto

The failure in adjuvant melanoma could cause BMS and Opdualag to miss out on a market opportunity that is nearly twice as large as its current approved indication, according to analysts.

Bristol Myers Squibb’s LAG-3 blocker Opdualag came up short in the Phase III RELATIVITY-098 study, unable to significantly improve recurrence-free survival as an adjuvant treatment for stage III to IV melanoma, the pharma disclosed on Thursday.

In an investor note following the announcement, BMO Capital Markets analysts called the late-stage stumble “somewhat of a surprise,” especially given BMS’ “prior positive commentary” on the potential benefit of Opdualag in this indication.

Thursday’s failure “likely significantly reduces” Opdualag’s long-term revenue prospects, BMO contends.

Analysts at Leerink Partners likewise see the Phase III fail as a missed opportunity for BMS. “We note that the adjuvant setting presents a significant opportunity, with nearly twice the market size of first-line metastatic melanoma,” the firm wrote in an investor note Thursday. Leerink estimates Opdualag’s peak sales to hit $1.9 billion in 2028.

RELATIVITY-098 tested Opdualag, a fixed-dose combination of the PD-1 blocker nivolumab and the LAG-3 inhibitor relatlimab, against monotherapy with nivolumab alone, a common therapy for advanced melanoma. The study enrolled patients with stage III to IV melanoma who had undergone complete resection. The primary outcome of interest was recurrence-free survival, while key secondary endpoints included overall survival and distant metastasis-free survival.

BMS did not provide specific data in its news release on Thursday, announcing only that Opdualag “did not meet its primary endpoint.” Safety findings were consistent with what had been established in prior studies.

“Patients whose tumors are completely resected before treatment may not have sufficient antitumor T cells in place for Opdualag to have its maximal effect,” Jeffrey Walch, Opdualag’s global program lead at BMS, said in a statement, pointing to post-surgical effects as the potential reason for the failure.

Opdualag, which is already approved for unresectable or metastatic melanoma in patients aged 12 and up, “remains a standard of care in the first-line” setting in this indication, Walch added.

BMS is facing strong patent headwinds in the coming years, with key protections for Eliquis and Opdivo set to expire in 2028. The pharma has been beefing up its late-stage pipeline in order to shore up its earnings. BMS has also enacted sweeping cost cuts to help its balance sheet, including the $1.5-billion savings plan announced in April 2024 and an additional $2 billion target through 2027, revealed recently during its fourth-quarter earnings report.

Tristan is an independent science writer based in Metro Manila, with more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.
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