Bristol Myers Squibb’s Opdivo has plenty of competition in its current bladder cancer indication—so it’s hoping to strike out on its own in a new area of the disease.
The company revealed Thursday that its PD-1 fighter, against placebo, had lengthened the time muscle-invasive urothelial carcinoma patients could remain disease-free after surgery. All patients saw benefit, regardless of whether their tumors expressed levels of biomarker PD-L1.
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The results mark the first time a member of the PD-1/L1 class has cut patients’ risk of relapse in the adjuvant setting—and they “point to the potential for (Opdivo) to become a new standard of care,” Matthew Galsky, M.D., professor and Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai, said in a statement.
BMS is glad to have that distinction. Currently, Opdivo is cleared only in metastatic bladder cancer, where Merck’s Keytruda, AstraZeneca’s Imfinzi, Roche’s Tecentriq and Pfizer and Merck KGaA’s Bavencio also bear green lights.
It’s not for lack of trying, though. Earlier this year, Roche revealed that Tecentriq had flopped a trial in the same setting as Opdivo’s latest win, failing to show a benefit compared with placebo at delaying the time to cancer recurrence or death.
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Meanwhile, the victory comes on the heels of the European Society for Medical Oncology’s virtual annual meeting, where Opdivo racked up an adjuvant success in esophageal cancer. With immuno-oncology drugmakers working to move their medicines—initially approved only in the metastatic setting—earlier into treatment, Bristol’s drug has now posted positive adjuvant trials in those two disease areas plus melanoma.