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BMS Combo Immunotherapy Opdualag Approved in Europe for Biomarker-Defined Melanoma Patients

NEW YORK – The European Commission on Friday approved Bristol Myers Squibb's LAG-3 combination drug Opdualag (nivolumab and relatlimab) as a first-line treatment for unresectable or metastatic melanoma patients whose tumors express PD-L1 in fewer than 1 percent of cells.

"Opdualag is now the first approved LAG-3-blocking antibody combination for advanced melanoma in the European Union," BMS Chief Medical Officer Samit Hirawat said in a statement. "The RELATIVITY-047 study demonstrated the important benefit of inhibiting both LAG-3 and PD-L1 with our novel immunotherapy combination."

The EC's approved indication for Opdualag is narrower than the one approved by the US Food and Drug Administration in March for unresectable or metastatic melanoma patients regardless of PD-L1 expression. Both agencies reviewed data from the Phase II/III RELATIVITY-047 trial, but the EC gave weight to an exploratory analysis looking at treatment outcomes by PD-L1 expression.

In that study the median progression-free survival on Opdualag was 10.1 months versus 4.6 months with BMS's Opdivo (nivolumab) in all patients in the trial. However, when the EC looked into outcomes based on PD-L1 expression status, the median progression-free survival was 15.7 months with Opdualag versus 14.7 months on Opdivo in patients with PD-L1 expression in 1 percent of tumor cells or greater, and 6.4 months versus 2.9 months, respectively, in those with PD-L1 expression in less than 1 percent of tumor cells. The similar outcomes in the former group prompted the EC to restrict its approval to only those with low or no PD-L1-expressing melanoma tumors. 

The different approvals from two regulatory bodies may reignite debates in the oncology community about the utility of PD-L1 to predict immunotherapy response. Many oncologists find PD-L1 expression an unreliable biomarker, while others rely upon it in the absence of something better.

BMS, meanwhile, is studying Opdualag in various all-comer and biomarker-defined patient populations, including in mismatch repair-deficient and microsatellite instability-high cancers, along with LAG-3, and PD-L1 expressing tumors.

This week, at the European Society for Medical Oncology Congress, BMS presented data on Opdualag's activity as a neoadjuvant treatment for non-small cell lung cancer but found the combo drug had similar outcomes to those receiving just Opdivo.