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Nivolumab Monotherapy in Metastatic Urothelial Carcinoma

By: Sarah Campen, PharmD
Posted: Friday, March 2, 2018

Nivolumab monotherapy in patients with metastatic urothelial carcinoma continues to show “clinically meaningful, durable efficacy,” according to Padmanee Sharma, MD, PhD, of MD Anderson Cancer Center in Houston, and colleagues. The 2-year follow-up results from the nivolumab monotherapy arm of the ongoing CheckMate 032 study were presented at the 2018 Genitourinary Cancers Symposium in San Francisco (Abstract 414).

The multicenter, open-label study included patients with metastatic urothelial carcinoma who had previously received at least one platinum-based therapy. All participants received nivolumab at 3 mg/kg intravenously every 2 weeks until disease progression or treatment discontinuation.

At a minimum of 24 months of follow-up, 11 of the original 78 patients (14.1%) remain on treatment, with treatment discontinuation (66.7%) mostly due to disease progression. The updated objective response rate was 25.6%, with 1 additional complete response achieved, for a complete response rate of 8%. The 2-year overall survival rate was 37%, and the 2-year progression-free survival rate was 17.2%. The median duration of response has not yet been reached.

In addition, the investigators noted the results were similar regardless of PD-L1 expression status. No new toxicity signals were observed with the longer-term follow-up.

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