Bladder Cancer Coverage from Every Angle

Extended Follow-up With Nivolumab Plus Ipilimumab in Advanced Urothelial Cancer

By: Susan Reckling
Posted: Friday, October 30, 2020

Based on extended follow-up data from the phase I/II CheckMate 032 trial, antitumor activity was demonstrated with nivolumab monotherapy as well as two different regimens of combination therapy with nivolumab and ipilimumab in patients with platinum-pretreated advanced or metastatic urothelial carcinoma. According to Padmanee Sharma, MD, PhD, of MD Anderson Cancer Center, Houston, and colleagues, the N1I3 regimen—nivolumab at 1 mg/kg and ipilimumab at 3 mg/kg—appeared to be the most promising and will be compared with chemotherapy in the ongoing phase III CheckMate 901 trial of previously untreated patients with metastatic urothelial cancer ( identifier NCT03036098). These findings were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 749P).

The long-term outcomes were based on a minimum follow-up of 56.2 months with nivolumab monotherapy, 57.0 months with N3I1 (nivolumab at 3 mg/kg and ipilimumab at 1 mg/kg), and 26.7 months with N1I3. The objective response rates were highest with N1I3, both per investigator review and blinded independent central review: 42% and 38%, respectively; the corresponding objective response rates for nivolumab monotherapy versus N3I1 were 26% and 22% versus 26% and 23%.

The investigators noted that on blinded independent central review, there was a benefit observed in all study cohorts regardless of tumor PD-L1 status. However, patients with PD-L1 expression of at least 1% who received N1I3 had the best objective response rate at 58%. In terms of survival, again the N1I3 regimen yielded the longest median overall survival compared with nivolumab monotherapy and N3I1: 15.3 months vs. 9.9 months and 7.4 months.

As for toxicity, 80% of patients given the N1I3 regimen experienced any-grade treatment-related adverse events, with similar rates associated with the other regimens. A total of 42% of these events were grade 3 or 4 in the N1I3 cohort.

Disclosure: For full disclosures of the study authors, visit

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