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Japan Approves Pembrolizumab for Urothelial Carcinoma

Jason M. Broderick @jasoncology
Published: Tuesday, Jan 02, 2018

Dr. Roy Baynes
Roy Baynes, MD, PhD
The Japanese Ministry of Health, Labor and Welfare has approved the use of pembrolizumab (Keytruda) for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, according to Merck, the manufacturer of the PD-1 inhibitor.

Patients who received pembrolizumab had fewer toxicities than those treated with chemotherapy. The incidence of treatment-related adverse events (AEs) was lower with pembrolizumab compared with chemotherapy, respectively, for any grade (60.9% vs 90.2%) and for AEs of grade 3-5 severity (15.0% vs 49.4%).

Treatment-related AEs occurring in ≥10% of participants were generally lower with pembrolizumab as opposed to chemotherapy, respectively, including for fatigue (13.9% vs 27.8%), nausea (10.9% vs 24.3%), diarrhea (9.0% vs 12.9%), asthenia (5.6% vs 14.1%), and anemia (3.4% vs 24.7% with chemotherapy).

The incidence of pruritus was higher in the pembrolizumab arm at 19.5% versus the chemotherapy group at 2.7%. Immune-related AEs that were higher with pembrolizumab compared with chemotherapy, respectively, included thyroid abnormalities (9.4% vs 1.6%), pneumonitis (4.1% vs 0.4%), and colitis (2.3% vs 0.4%).

Fifteen patients in the pembrolizumab arm and 28 patients in the chemotherapy group discontinued treatment due to a treatment-related AE. Each arm had 4 treatment-related deaths.

Pembrolizumab was previous approved in Japan for indications in melanoma, lung cancer, and Hodgkin lymphoma. Merck (MSD) reported that it will market pembrolizumab in Japan and promote it along with Taiho Pharmaceutical.
Bellmunt J, de Wit R, Vaughn DJ, et al. Keynote-045: open-label, phase III study of pembrolizumab versus investigator’s choice of paclitaxel, docetaxel, or vinflunine for previously treated advanced urothelial cancer. Presented at: 2016 SITC Annual Meeting; November 9-13, 2016; National Harbor, MD. Abstract 470.

 



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