KEY TAKEAWAYS
- The CheckMate-901 phase III trial aimed to compare the efficacy and safety of NIVO +GC to GC alone in unresectable/mUC patients.
- The primary endpoints were OS and PFS. The exploratory endpoint was ORR.
- The result demonstrated that the combined therapy was a superior first-line treatment for unresectable/mUC, enhancing OS and PFS.
Despite being the standard of care(SOC) for decades, cisplatin-based chemotherapy has shown limited improvement in treating unresectable/metastatic urothelial carcinoma (mUC). Researchers aimed to compare the efficacy and safety of nivolumab(NIVO) plus gemcitabine-cisplatin (GC) compared to GC alone.
Patients were administered NIVO 360 mg alongside GC every 3 weeks for a maximum of 6 cycles, followed by NIVO 480 mg every 4 weeks until disease progression, unacceptable toxicity, or up to a maximum of 2 years. Alternatively, some patients received GC every 3 weeks for up to 6 cycles.
Stratification factors included programmed death ligand 1 status and liver metastasis. The primary endpoints were overall survival (OS) and progression-free survival (PFS) assessed by blinded independent central review (BICR). An exploratory endpoint was the objective response rate (ORR) per BICR.
Of 304 patients in each group, those receiving NIVO+GC demonstrated significantly improved OS (HR=0.78, 95% CI 0.63–0.96, P=0.0171) and PFS (HR=0.72, 95% CI 0.59–0.88, P=0.0012) compared to GC alone over a median follow-up of 33.6 months. ORR and Complete response(CR) rates were higher with NIVO+GC (57.6% ORR, 21.7% CR) than with GC alone (43.1% ORR, 11.8% CR).
The median duration of CR (95% CI) was longer for NIVO+GC, 37.1 months (18.1–not estimable), compared to GC 13.2 months(7.3–18.4). Grade ≥ 3 treatment-related adverse events(TRAEs) occurred in 61.8% of patients in the NIVO+GC arm and 51.7% in the GC arm.
The result demonstrated that the combined therapy was a superior first-line treatment for unresectable/mUC, enhancing OS and PFS.
Clinical Trial: https://clinicaltrials.gov/study/NCT03036098
van der Heijden MS, Sonpavde GP, Powles TB, et al. Nivolumab plus gemcitabine-cisplatin versus gemcitabine-cisplatin alone for previously untreated unresectable or metastatic urothelial carcinoma: Results from the phase III CheckMate 901 trial. Ann Oncol. 2023;34(suppl_2):S1254-S1335. doi:10.1016/annonc/annonc1358.
