FDA Grants Priority Review to Nivolumab Plus Chemotherapy in mUC


Summary: The FDA has accepted for priority review nivolumab and cisplatin-based chemotherapy as a first line of treatment in patients with inoperable or metastatic urothelial carcinoma.

Bladder Cancer, Urinary Bladder Image: © reineg - stock.adobe.com

Bladder Cancer, Urinary Bladder Image: © reineg - stock.adobe.com

  • Priority review has been granted by the FDA to nivolumab (Opdivo) and cisplatin-based chemotherapy for the first-line treatment of patients with previously untreated unresectable or metastatic urothelial carcinoma (mUC).1
  • The priority review designation indicates that the FDA plans to act on an application within 6 months.
  • The Prescription Drug User Fee Act (PDUFA) target action date is April 5, 2024.

Nivolumab plus cisplatin-based chemotherapy has been granted priority review by the FDA in treatment-naive unresectable or mUC.1

The filing is supported by results from the phase 3 CheckMate -901 study (NCT03036098) and the FDA has set a PDUFA target action date of April 5, 2024.

“The FDA’s acceptance of our application for [nivolumab] in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma. There remains a clear need for efficacious first-line treatment options that may potentially help improve outcomes for patients with this hard-to-treat disease,” said Dana Walker, MD, MSCE, vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb, in a press release.

According to findings published in the New England Journal of Medicine and presented at the 2023 European Society for Medical Oncology Annual Congress, overall survival (OS; HR, 0.78; 95% CI, 0.63-0.96; P =.02) and progression-free survival (PFS; HR, 0.72; 95% CI, 0.59-0.88; P =.001) were improved with nivolumab/chemotherapy compared with gemcitabine/cisplatin alone. At a median follow-up of 33.6 months, the median OS was 21.7 months (95% CI, 18.6-26.4) in the nivolumab combination arm vs 18.9 months (95% CI, 15.7-22.4) in the chemotherapy arm. PFS was 34.2% in the combination arm vs 21.8% in the chemotherapy arm at 12 months, and the median PFS was 7.9 months vs 7.6 months, respectively.2

Objective response rate (ORR) was 57.6% in the nivolumab combination arm with a complete response rate (CRR) of 21.7% compared with an ORR of 43.1% and a CRR of 11.8% with chemotherapy alone. The median duration of response (DOR) was 37.1 months vs 13.2 months in the nivolumab combination and chemotherapy arms, respectively.

For safety, grade 3 or higher adverse events were observed in 61.8% of patients in the nivolumab combination arm and 51.7% in the chemotherapy arm; however, no new safety concerns were identified.2,3

A total of 608 patients were randomized into the phase 3 open-label study where patients were randomized to receive nivolumab in combination with ipilimumab or cisplatin-based chemotherapy followed by nivolumab monotherapy or standard-of-care chemotherapy alone.1,2

To be considered eligible for enrollment, patients needed to have histological or cytological evidence of metastatic or inoperable UC, not received any prior systemic chemotherapy for UC, have an ECOG performance status of 0-1, and follow specific methods of contraception, if applicable. Patients were not eligible to enroll if they had disease that was suitable for local therapy, any uncontrolled medical disorder, or had received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody.3

1. U.S. Food and Drug Administration accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. News release. Bristol Myers Squibb. December 5, 2023. Accessed December 5, 2023. https://tinyurl.com/a5k4rry3
2. Van der Heijden M, Sonpavde G, Powles T, et al. Nivolumab plus gemcitabine-cisplatin in advanced urothelial carcinoma. November 9, 2023. N Engl J Med. 2023;389(19):1778-1789. doi:10.1056/NEJMoa2309863
3. Study of nivolumab in combination with ipilimumab or standard of care chemotherapy compared to the standard of care chemotherapy alone in treatment of participants with untreated inoperable or metastatic urothelial carcinoma (CheckMate901). ClinicalTrials.gov. Updated November 30, 2023. Accessed December 5, 2023. https://clinicaltrials.gov/study/NCT03036098
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