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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 (ClinicalTrials.gov 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 oncologypro.esmo.org.



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