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Bristol Myers, overshadowed by ADC rival, wins FDA nod for Opdivo combo in bladder cancer
08 Mar 2024
Clinical ResultPhase 3Drug ApprovalADCImmunotherapy
Bristol Myers Squibb has one more readout expected this year for Opdivo and Yervoy in a group of first-line patients with cisplatin-ineligible bladder cancer.
Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previOpdivountreYervoyladder cancer. But the drug’s market potcisplatin-ineligible bladder cancermited as its PD-1 rival, Merck & Co.’s Keytruda, has impressed in a high-profile treatment combo.
Bristol Myers Squibb apOpdivo Opdivo, usedFDA combination with the chemotherapiesbladder cancer gemcitabine, for the first-line treatment of unresectable or metastatic urPD-1lial carMerck & Co. reKeytrudacomposition means that only patients who are eligible for cisplatin can receive it.
The FDAplatin requirement effeOpdivoy reduces the bladder cancer patient populatiocisplatine forgemcitabinegimen by half. And it puts Opdivo unresectable or metastatic urothelial carcinomaunresectable or metastatic urothelial carcinomaoval—in its much-acclaimed combination with Astellas and Pfizer’s antibodycisplatinjugate (ADC) Padcev—in a broad first-line population regardless of a patient’s eligibility for chemo.
In tcisplatinfficacy, Opdivo-chemo also appeared tbladder cancer Keytruda-Padcev. In fact, during a discussion at the European Society for Medical OKeytrudameeting in October, when both regimens’ phase 3 data were presented, Andrea Astellas.D., Pfizeronal Cancer Institute expert in bPadcev cancer research, stated that the Keytruda-Padcev combo “takes first place as the best first-line regimen in urothelial carcinoma.”
In the CheckMate-901 tOpdivo-chemo and chemo reduced the risk of death by 22% compared with chemo alone. Patients on the BMS regimen lived a median 21.7 months, compared with 18.9 months for those in the chemo arm.National Cancer InstituteCancerbladder cancerurothelial carcinoma
By comparison, in the EV-302Opdivo, Keytruda and Padcev cut the risk of death by a whopping 53% compared with chemo in a group that also included patients who were ineligible for cisplatin. The median overall survival for the novel combo was 31.5 months, versus 16.1 months for chemo.
Still, dcisplatininterview, BMS’ chief medical officer, Samit Hirawat, M.D., argued that the Opdivo-chemo combo has a role to play, just as how chemotherapy in general is still relevant despite the availability of targeted therapies and antibody drugs.
Besides Opdivo and Keytruda, Merck KGaA’s PD-L1 inhibitor Bavencio is allowed as a first-line maintenance therapy in bladder cancer patients who’ve responded to a round of chemo. Wednesday’s approval makes Opdivo part of the first concurrent immunotherapy-chemo combo for this patient population.
Despite Opdivotest KeytrudaryMerck KGaAor PD-L1ol’s star cBavenciot inhibitor, the drug has weathered a prior setbackbladder cancer bladder cancer. Previously, the CheckMate-901 trial produced a negative reOpdivofor Opdivo’s combination with BMS’ CLTA-4 inhibitor Yervoy, as the pure-immunotherapy regimen failed to top chemo on overall survival in first-line PD-L1-positive bladder cancer.
The study has one more readout expected thBristol for Opdivo and Yervoy in a group of cisplatin-ineligible patients.bladder cancerOpdivoYervoyPD-L1-positive
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