The FDA has set a Prescription Drug User Fee Act date of April 5, 2024 for nivolumab plus chemotherapy in unresectable or metastatic urothelial carcinoma.
The FDA has granted priority review to a supplemental biologics license application for frontline nivolumab (Opdivo) plus cisplatin-based chemotherapy as a treatment for adult patients with unresectable or metastatic urothelial carcinoma, according to a press release from Bristol Myers Squibb.1
The regulatory agency has set a Prescription Drug User Fee Act date of April 5, 2024 for their decision on approving the nivolumab-based regimen in this patient population.
“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,” Dana Walker, MD, MSCE, vice president and global program of gastrointestinal and genitourinary cancers at Bristol Myers Squibb, said in the press release.1 “We look forward to working with the FDA throughout the review of this application and hope to bring the first immunotherapy/chemotherapy combination to these patients in the U.S.”
Supporting data for the application came from the phase 3 CheckMate 901 trial (NCT03036098), which investigators presented at the 2023 European Society for Medical Oncology Congress (ESMO) and subsequently published in The New England Journal of Medicine.
In the trial, nivolumab plus gemcitabine/cisplatin produced a median overall survival (OS) of 21.7 months (95% CI, 18.6-26.4) compared with 18.9 months (95% CI, 14.7-22.4) using gemcitabine/cisplatin alone (HR, 0.78; 95% CI, 0.63-0.96; P = .02).2 Additionally, the median PFS was 7.9 months vs 7.6 months in each respective arm (HR, 0.72; 95% CI, 0.59-0.88; P = .001). The PFS rate in each respective arm was 34.2% vs 21.8% at 12 months.
Investigators reported grade 3 or higher adverse effects in 61.8% of patients who received nivolumab plus chemotherapy and 51.7% of those who were treated with chemotherapy alone. The safety profile of the experimental regimen was comparable with previous reports of each individual agent, and investigators observed no new safety signals.
“This survival benefit seen with nivolumab in combination with cisplatin-based chemotherapy represents a momentous accomplishment that may provide hope for patients [with urothelial cancer] as the first concurrent chemo-immunotherapy combination to demonstrate such an improvement compared [with] standard-of-care cisplatin-based combinations,” lead study author Michiel S. van der Hejiden, MD, PhD, a research group leader in the Department of Medical Oncology at Netherlands Cancer Institute in Amsterdam, Netherlands, said in a press release on these data.3 “The implications of these data have the potential to be practice-changing and transform the way cisplatin-eligible patients are treated.”
The CheckMate 901 trial included 608 patients who were randomly assigned to receive 360 mg of nivolumab intravenously plus gemcitabine/cisplatin every 3 weeks for up to 6 cycles followed by 480 mg of nivolumab every 4 weeks for up to 2 years or chemotherapy alone every 3 weeks for up to 6 cycles.
The trial’s primary end points were OS and PFS. Objective response rate and safety were exploratory end points.
Patients 18 years and older who had histologically or cytologically confirmed metastatic or surgically inoperable transitional cell cancer of the urothelium and no prior systemic chemotherapy for their disease were eligible to enroll on the trial. Having an ECOG performance status of 0 or 1 was another requirement for enrollment.