Dr Grivas on Key Data From the CheckMate 901 Trial in Urothelial Cancer

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Petros Grivas, MD, PhD, discusses outcomes associated with the phase 3 CheckMate 901 trial in metastatic or unresectable urothelial carcinoma.

Petros Grivas, MD, PhD, physician, Seattle Cancer Care Alliance, associate professor, Division of Medical Oncology, University of Washington (UW) School of Medicine, clinical director, Genitourinary Cancers Program, UW Medicine, associate professor, Clinical Research Division, Fred Hutchinson Cancer Research Center, discusses outcomes associated with the phase 3 CheckMate 901 trial (NCT03036098) in metastatic or unresectable urothelial carcinoma, highlighting the importance of these data.

This randomized, open-label trial evaluated the efficacy of concurrent frontline nivolumab (Opdivo) plus chemotherapy vs chemotherapy alone in cisplatin-eligible patients with previously untreated, metastatic or unresectable urothelial carcinoma, Grivas begins. Patients were randomly assigned 1:1 to receive nivolumab and standard-of-care gemcitabine/cisplatin, followed by nivolumab maintenance therapy, or gemcitabine/cisplatin, he details.

Grivas notes that the trial was designed prior to the readout of results from the JAVELIN Bladder 100 trial (NCT02603432), which showed that avelumab (Bavencio) maintenance therapy plus best supportive care provides significant survival benefit for patients with urothelial cancer who did not experience progression on cisplatin or carboplatin-based chemotherapy.

In a presentation at the 2023 ESMO Congress, the study showed that nivolumab plus chemotherapy significantly increased both overall survival (OS) and progression-free survival (PFS) vs chemotherapy alone, Grivas states. The median OS was 18.9 months (95% CI, 14.7-22.4) with chemotherapy vs 21.7 months (95% CI, 18.6-26.4) with the combination approach, which translated to a 22% reduction in the risk of death (HR, 0.78; 95% CI, 0.63-0.96; P = .0171), Grivas reports. Additionally, the combination produced a median PFS of 7.9 months (95% CI, 7.6-9.5) compared with 7.6 months (95% CI, 6.1-7.8) with chemotherapy alone, reducing the risk for progression by 28% (HR, 0.72; 95% CI, 0.59-0.88; P = .0012).

Furthermore, the overall response rate was higher with the nivolumab triplet vs chemotherapy doublet at 57.6% (95% CI, 51.8%-63.2%) vs 43.15% (95% CI, 37.5%-48.9%), respectively, Grivas continues. Notably, a subset of patients achieved deep, durable complete responses (CR) with the nivolumab combination despite its shorter treatment duration of no more than 2 years, he adds. The triplet produced a CR rate of 21.7% vs 11.8% with chemotherapy, and the duration of CR was almost 3 times longer in the nivolumab arm (37.1 months) vs the chemotherapy arm (13.2 months). As expected, toxicity was higher with the nivolumab regimen, but the combination's safety profile was deemed manageable, Grivas concludes.

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