Dr Sonpavde on OS Data With Ipilimumab/Nivolumab in Previously Untreated, Advanced Urothelial Carcinoma

“At the end of the day, ipilimumab/nivolumab could not attain superiority in both the cisplatin-ineligible cohort and the PD-L1–high cohort as first-line therapy in advanced urothelial carcinoma. This is disappointing; [however], one of the silver linings here is that there were durable responders, especially durable complete responders with ipilimumab/nivolumab.”

Guru P. Sonpavde, MD, medical director of genitourinary oncology, assistant director of the Clinical Research Unit, and Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, detailed the efficacy data of ipilimumab (Yervoy) plus nivolumab (Opdivo) compared with gemcitabine plus platinum-based chemotherapy for the treatment of patients with previously untreated, unresectable or metastatic urothelial cancer.

The phase 3 CheckMate 901 trial (NCT03036098) included 2 sub studies, which compared ipilimumab plus nivolumab with gemcitabine plus cisplatin or gemcitabine plus carboplatin; and gemcitabine and cisplatin plus nivolumab compared with gemcitabine plus cisplatin. Specifically, data from the gemcitabine plus platinum vs ipilimumab plus nivolumab sub study revealed that the median overall survival (OS) was not significantly different between the 2 arms, Sonpavde began. He noted that the OS difference was more modest than the cisplatin-eligible comparison. In patients with tumor PD-L1 expression of at least 1%, the median OS was 17.2 months (95% CI, 12.3-23.2) and 15.2 (95% CI, 10.9-18.4) in the ipilimumab plus nivolumab and gemcitabine plus platinum arms, respectively (HR, 0.87; 97.48% CI, 0.61-1.23; P = .364).

Based on these data, ipilimumab plus nivolumab did not demonstrate superiority in both the cisplatin-ineligible and PD-L1–high cohorts for the first-line treatment of patients with advanced urothelial carcinoma, Sonpavde emphasized. Although the results were disappointing, a highlight of the data was that there were patients who achieved durable complete responses on ipilimumab plus nivolumab, he continued. Potential identification of biomarkers in select patients could help provide better use of ipilimumab plus nivolumab as first-line treatment, he said. However, CheckMate 901 was negative, and therefore, does not affect the standard of care for first-line treatment, Sonpavde concluded.