Bristol-Myers Squibb’s Opdivo-Yervoy combo is awaiting some critical decisions in non-small cell lung cancer, but in the meantime, it’s making its mark in a smaller indication, too.
The immuno-oncology duo topped chemo at extending the lives of phase 3 trial patients with previously untreated malignant pleural mesothelioma (MPM), the company said Monday.
The rare cancer, which forms in the lining of the lungs, is most commonly caused by asbestos exposure. It's also a lethal one: On average, patients live for less than one year, and only 10% make it to the five-year mark post-diagnosis, BMS said.
Bristol will present the full results at a future medical meeting, but between now and then, it’ll be discussing them with global regulators.
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An indication in MPM would add another notch to the pairing’s belt. The regimen already bears go-aheads in melanoma, kidney cancer and liver cancer, among others.
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Unlike in those hotly contested areas, though, no members of Opdivo’s PD-1/PD-L1 currently boast an MPM green light. Opdivo's archrival, Keytruda, last year suffered a rare phase 3 miss in second-line patients, failing to improve survival outcomes against chemo, Leerink Partners analyst Daina Graybosch wrote in a Monday note to clients.
Still, an approval wouldn't make much of a mark for Bristol sales-wise. About 3,300 new mesothelioma cases are reported in the U.S. each year, and that number "is declining, due to reduced population-wide exposure to asbestos," Graybosch wrote.
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The real highlights for the checkpoint inhibitor combo could come later this year with nods in the ultra-lucrative non-small cell lung cancer field.
Bristol has watched from the sidelines for years as Merck’ has gobbled up market share with its Keytruda-chemo combo, but it’s finally up for some FDA decisions of its own: The agency is set to decide on Opdivo-Yervoy in previously treated patients by May 15 and on Opdivo-Yervoy-chemo in the same population by August 6.