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FDA Approves Opdivo for First Line Treatment in Bladder Cancer

Phase 3 trial demonstrates statistically significant improvement in overall survival and progression-free survival compared to cisplatin-gemcitabine alone.

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By: Kristin Brooks

Managing Editor, Contract Pharma

Bristol Myers Squibb received approval from the U.S. FDA Opdivo (nivolumab), in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. This approval is based on results from the Phase 3 CheckMate –901 trial which evaluated Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy, compared to cisplatin-gemcitabine alone, for patients with previously untreated unresectable or metastatic UC. The primary efficacy endpoints were overall survival (OS) and progression-free survival (PFS).
 
In the trial, with a median follow-up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone. Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone.
 
Additionally, in exploratory analyses, treatment with Opdivo in combination with cisplatin and gemcitabine resulted in an objective response rate (ORR) of 57.6% versus 43.1% with cisplatin-gemcitabine alone. The complete response (CR) rate and partial response (PR) rate seen in patients treated with Opdivo in combination with cisplatin and gemcitabine was 22% and 36%, respectively, versus 12% and 31% with cisplatin-gemcitabine alone.

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