Nivolumab Monotherapy May Yield 8% Complete Response Rate in Urothelial Carcinoma
Seventy-eight patients with metastatic urothelial carcinoma received intravenous nivolumab until disease progression or discontinuation.
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Complete responses may be observed in about 8% of patients with metastatic urothelial carcinoma receiving nivolumab monotherapy regardless of PD-L1 status, according to research being presented at the 2018 Genitourinary Cancers Symposium in San Francisco, California.1
Previous data suggested that nivolumab monotherapy may improve outcomes after progression on at least 1 prior platinum therapy. Here researchers present updated results from the phase 1/2 CheckMate 032 study (ClinicalTrials.gov Identifier: NCT01928394).
Seventy-eight patients with metastatic urothelial carcinoma received intravenous nivolumab until disease progression or discontinuation for other reasons; the median age was 65.5 years and two-thirds of patients had received at least 2 prior therapies.
The minimum follow-up was 24 months. Two-thirds of patients discontinued treatment because of disease progression; 14.1% of patients were still receiving treatment when data were locked. The overall response, progression-free survival (PFS), and overall survival (OS) rates were not affected by PD-L1 status.
The objective response rate was 25.6%, the median PFS was 2.8 months, and the median OS was 10 months; the median response duration was not reached. The complete response rate was 8%.
More than one-fourth (28.2%) of patients had a grade 3 to 4 adverse event; one case of grade 5 pneumonitis was noted.
The authors concluded that nivolumab “showed clinically meaningful, durable efficacy with promising long-term survival regardless of PD-L1 expression, and no new toxicity signals with longer-term follow-up.”
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- Sharma P, Callahan MK, Bono P, et al. Nivolumab monotherapy in metastatic urothelial carcinoma: longer-term efficacy and safety results from the CheckMate 032 study. Oral presentation at: 2018 Genitourinary Cancers Symposium; February 8-10, 2018; San Francisco, CA.