Bristol Myers' Opdivo-Yervoy combo joins Roche on the postsurgery kidney cancer flop list

Merck & Co.’s Keytruda can cross another player off its potential competitor list in postsurgery kidney cancer.

Bristol Myer Squibb’s dual immuno-oncology combination of Opdivo and Yervoy failed when used as an adjuvant treatment after surgery in a phase 3 trial in localized renal cell carcinoma, the company said Friday.

An independent data review panel reached the conclusion after finding the combo didn’t top placebo at preventing disease recurrence or death in moderate- or high-risk relapse patients.

Opdivo and Yervoy’s flop follows Roche's disclosure last week for Tecentriq in high-risk patients. The two back-to-back trial failures make Keytruda the only PD-1/L1 inhibitor with a clinical win—and an approval—in postsurgery early-stage kidney cancer. That market is pegged to be worth $3.4 billion for the drug class, according to SVB Securities analyst Daina Graybosch, Ph.D.

There remains a glimmer of hope for BMS. Part B of the phase 3 CheckMate-914, which evaluates Opdivo alone in adjuvant kidney cancer, has yet to read out. But given that Opdivo’s Yervoy pairing failed, the chance of success for Opdivo monotherapy looks small.

Over the years, the BMS PD-1/CTLA-4 combo has recorded a number of failures, most recently in first-line bladder cancer and last year in head and neck cancer.

The early-stage kidney cancer miss also comes as competition in advanced disease intensifies. The Opdivo-Yervoy cocktail has been doctors’ favorite for treating newly diagnosed, advanced intermediate- and poor-risk kidney cancer patients, according to an SVB survey back in 2020.

Building on that use and another existing approval of the combination of Opdivo and small molecule tyrosine kinase inhibitor Cabometyx, Exelixis recently showed that adding Cabometyx to Opdivo and Yervoy could reduce the risk of disease progression or death by 27% in previously untreated patients.

Keytruda boasts two approvals in the first-line kidney disease setting for uses alongside Pfizer’s Inlyta and Eisai-partnered Lenvima.