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Bristol Myers Squibb snags new Opdivo-Yervoy nod but chalks up failure in melanoma

Bristol Myers Squibb’s Opdivo-Yervoy pairing is on a roll with its fourth FDA nod this year. But it wasn’t all good news for the dual-immunotherapy regimen.

In stage 3 or 4 melanoma patients who had had their tumors completely removed, adding Yervoy to Opdivo didn’t significantly extend the time to cancer returning or death regardless of patients’ levels of biomaker PD-L1, the company said Friday. The all-comer failure comes about a year after analysis in the PD-L1-low population showed no additional benefits for the dual regimen compared with solo Opdivo.

Melanoma is Opdivo and Yervoy’s home base; both drugs got their initial FDA nods as monotherapies in the skin cancer and their first green light as a combo was in the BRAF wild-type form of the disease. But so far, checkpoint inhibitors—which made their name in the metastatic setting—have seen mixed results moving earlier into treatment.

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BMS still tried to spin the CheckMake-915 adjuvant melanoma failure in a positive light, stressing in a statement that findings from the trial “reinforced the established benefit of Opdivo monotherapy as a standard of care in the adjuvant setting.” In 2017, Opdivo earned its adjuvant melanoma nod on the strength of data showing it topped Yervoy, reducing the risk of melanoma recurrence by 35%. Yervoy snagged its own post-surgery approval in 2015.

“We designed this study to determine if dual immunotherapy has the potential to bring additional benefits to patients in this setting, understanding the high benchmark we would need to exceed with this trial,” Sabine Maier, BMS’ head of oncology clinical development, said in a statement. The New York pharma still intends to further evaluate the combo in earlier stages of melanoma, she added.

But just as the pair chalked up that melanoma failure in the post-surgery setting, it also snagged a new go-ahead for treating newly diagnosed patients with malignant pleural mesothelioma that cannot be removed by surgery. The disease is a cancer of the lungs’ lining caused by inhaling asbestos fibers.

Data unveiled at this year’s World Conference on Lung Cancer’s virtual presidential symposium showed Opdivo and Yervoy together slashed patients’ risk of death by 26%, helping them live a median four months longer on top of the 14.1 months chemotherapy delivered.

Front-line mesothelioma marks the fourth new U.S. indication the combo has added to its label this year. In March, it secured a go-ahead in previously treated liver cancer. More importantly, the duo broke into the lucrative non-small cell lung cancer market with two nods in the first-line metastatic setting, one for those whose tumors bear levels of PD-L1 of at least 1% and the other for use alongside chemo regardless of PD-L1 expression.