BMS Faces Setback in Melanoma Treatment as Opdualag Fails Phase III Trial

Bristol Myers Squibb (BMS) encountered a significant obstacle in its oncology pipeline as its LAG-3 blocker Opdualag failed to meet its primary endpoint in a crucial Phase III study for adjuvant melanoma treatment. This development could potentially limit the drug's market opportunity and impact BMS's long-term revenue prospects.

RELATIVITY-098 Study Results

The Phase III RELATIVITY-098 study evaluated Opdualag, a fixed-dose combination of the PD-1 blocker nivolumab and the LAG-3 inhibitor relatlimab, against nivolumab monotherapy in patients with stage III to IV melanoma who had undergone complete resection. The primary outcome of interest was recurrence-free survival, with overall survival and distant metastasis-free survival as key secondary endpoints.

BMS announced that Opdualag "did not meet its primary endpoint" in improving recurrence-free survival as an adjuvant treatment. While specific data were not provided, the company noted that safety findings were consistent with previous studies.

Jeffrey Walch, Opdualag's global program lead at BMS, suggested that post-surgical effects might have contributed to the failure, stating, "Patients whose tumors are completely resected before treatment may not have sufficient antitumor T cells in place for Opdualag to have its maximal effect."

Market Implications and Analyst Perspectives

The failure in the adjuvant melanoma setting is viewed as a significant setback for BMS, potentially limiting Opdualag's market opportunity. Analysts from BMO Capital Markets described the late-stage stumble as "somewhat of a surprise," especially given BMS's previous positive outlook on the drug's potential in this indication.

Leerink Partners analysts highlighted the missed opportunity, noting that the adjuvant setting presents a market nearly twice the size of first-line metastatic melanoma. They estimate Opdualag's peak sales to reach $1.9 billion in 2028, but this projection may now be in question.

Despite the setback, BMS emphasized that Opdualag "remains a standard of care in the first-line" setting for unresectable or metastatic melanoma in patients aged 12 and up, its current approved indication.

BMS's Strategic Outlook

This clinical trial failure comes at a challenging time for BMS, which is facing significant patent expirations for key products like Eliquis and Opdivo in 2028. In response to these headwinds, the company has been actively bolstering its late-stage pipeline and implementing cost-cutting measures.

BMS announced a $1.5-billion savings plan in April 2024 and recently revealed an additional $2 billion cost reduction target through 2027 during its fourth-quarter earnings report. These strategic moves underscore the company's efforts to navigate the complexities of drug development and maintain its competitive position in the evolving pharmaceutical landscape.