Bristol Myers' Opdivo stages comeback in bladder cancer, teeing up 2 'Merck' showdowns

After one combination’s failure, Bristol Myers Squibb is celebrating a new triumph in bladder cancer. But a showdown with the two “Merck” companies likely lies ahead.

Adding Opdivo to chemotherapy significantly extended the lives of patients with newly diagnosed bladder cancer who are eligible for cisplatin-based chemo, a phase 3 study has shown. The combo also did better at staving off tumor progression than chemo alone, BMS said Tuesday.

The latest win comes after the same phase 3 trial, coded CheckMate-901, found Opdivo’s pairing with BMS’ own CTLA-4 inhibitor Yervoy didn’t work in bladder cancer patients whose tumors express the PD-L1 biomarker.

Now, the positive result will likely give BMS a chance to challenge Merck KGaA in bladder cancer. The German company’s Bavencio is currently a standard of care as a maintenance therapy in patients who have responded to an initial round of platinum-based chemo. Cisplatin is a type of platinum chemo.

The two regimens are different. While Bavencio is given as a single agent after chemo, the CheckMate-901 trial evaluated the Opdivo-chemo combo as an initial treatment, followed by Opdivo monotherapy.

Even more competition could be on its way. Industry watchers are keeping a close eye on the phase 3 EV-302 trial for the combination of Merck’s Keytruda with Astellas and Seagen’s antibody-drug conjugate Padcev in front-line bladder cancer—regardless of cisplatin eligibility. That study is expected to read out later this year. Leerink Partners (previously SVB Securities) analysts have projected Padcev’s peak sales opportunity in front-line bladder cancer is nearly $5 billion across the U.S. and Europe.

The Keytruda-Padcev regimen recently won an FDA accelerated approval in first-line, cisplatin-ineligible bladder cancer, a field that's practically a PD-1/L1 graveyard. Keytruda and chemo had previously failed to significantly outperform chemo alone in that setting, leading the FDA to restrict the Merck drug's approval to a specific subset of patients.

Meanwhile, two other companies had their approvals completely scrapped in bladder cancer. AstraZeneca in 2021 voluntarily withdrew Imfinzi’s use in previously treated bladder cancer after a confirmatory trial flop in previously untreated patients.

A few months later, Roche pulled Tecentriq’s first-line indication in cisplatin-ineligible patients after an unfavorable final analysis from a phase 3 trial.

In addition to the new first-line win, Opdivo boasts an approval in previously treated bladder cancer and as an adjuvant treatment in high-risk early bladder cancer following surgical resection.