Dr. Bellmunt Shares KEYNOTE-045 Data for Pembrolizumab Versus Chemotherapy in Bladder Cancer

Joaquim Bellmunt, MD, PhD, attending physician of Solid Tumor Oncology at Dana-Farber Cancer Institute, discusses findings from the phase III KEYNOTE-045 study, which compared second- or third-line pembrolizumab with investigator-choice chemotherapy as a treatment for patients with metastatic or locally advanced, unresectable urothelial carcinoma. All patients in the study had recurred or progressed following platinum-based chemotherapy.

Findings from the KEYNOTE-045 study were released at the Society for Immunotherapy of Cancer (SITC) 31st Annual Meeting & Associated Programs. The coprimary endpoints of the study were overall survival (OS) and progression-free survival (PFS). In 542-patient study, patients were evenly randomized to receive pembrolizumab at 200 mg every 3 weeks (n = 270) or paclitaxel, docetaxel, or vinflunine (n = 272). The data-cutoff for this analysis was September 7, 2016.

Overall, there was a 27% reduction in the risk of death with pembrolizumab versus chemotherapy, says Bellmunt. The median OS was 10.3 months with pembrolizumab versus 7.4 months with chemotherapy (HR, 0.73, P = .0022). The estimated 1-year OS rate was 43.9% with pembrolizumab compared with 30.7% in the chemotherapy arm. PFS was not improved with the immunotherapy. The median PFS was 2.1 months with pembrolizumab versus 3.3 months for chemotherapy arm (HR, 0.98; 95% CI, 0.81-1.19; P = .42).

The objective response rate (ORR) was also higher with pembrolizumab, Bellmunt noted. In the pembrolizumab arm the ORR was 21.1% versus 11.4% with chemotherapy. The complete response rate was 7% with the PD-1 inhibitor versus 3.3% with chemotherapy.

The toxicity profile also favored the use of immunotherapy in these patients, noted Bellmunt. There were fewer treatment-related adverse event leading to discontinuations in the pembrolizumab arm (n = 15) versus chemotherapy (n = 28).

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