Immunotherapy-chemotherapy combination extends survival in metastatic urothelial carcinoma
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The addition of nivolumab to cisplatin-based chemotherapy improved outcomes compared with standard regimens for certain patients with advanced urothelial carcinoma, according to the agent’s manufacturer.
Nivolumab (Opdivo, Bristol Myers Squibb) is a PD-1 inhibitor approved in the United States for several oncology indications, including treatment of specific patients with melanoma, lung cancer, renal cell carcinoma and classic Hodgkin lymphoma.
The randomized phase 3 CheckMate -901 trial included a primary study and substudy.
The primary study compared nivolumab plus the anti-CTLA-4 antibody ipilimumab (Yervoy, Bristol Myers Squibb) with standard cisplatin- or carboplatin-based chemotherapy for patients with untreated unresectable or metastatic urothelial carcinoma. That component of the trial is ongoing.
The substudy included 608 patients with unresectable or metastatic urothelial carcinoma eligible for cisplatin-based chemotherapy.
Researchers randomly assigned patients to first-line treatment with 360 mg nivolumab in combination with chemotherapy every 3 weeks or chemotherapy alone.
The substudy met its dual primary endpoints, showing statistically significant OS and PFS improvements with the nivolumab regimen per blinded independent central review.
The combination of nivolumab and cisplatin-based chemotherapy also exhibited a safety profile consistent with the known profiles of the individual agents. Researchers identified no new safety signals.
“[This] news is yet another example of the power of immunotherapy combinations to transform outcomes for patients with cancer,” Dana Walker, MD, MSCE, vice president and global program lead for genitourinary cancers with Bristol Myers Squibb, said in a company-issued press release. “Opdivo with cisplatin-based chemotherapy is the first immunotherapy-based combination to improve both overall survival and progression-free survival in patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, reinforcing the benefits of Opdivo-based treatments seen across a variety of genitourinary cancers, including durable survival in advanced renal cell carcinoma and a reduced risk [for] recurrence in resectable muscle-invasive urothelial carcinoma.”
Complete data from CheckMate -091 will be presented at a medical conference and shared with health authorities, according to the press release.
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