Japan Approves Keytruda for Patients with Advanced Urothelial Carcinoma

Japan Approves Keytruda for Patients with Advanced Urothelial Carcinoma

Keytruda (pembrolizumab) was approved in Japan for the treatment of patients with radically unresectable (cannot be removed with surgery) urothelial carcinoma whose disease deteriorated after chemotherapy, Merck recently announced.

Keytruda is a humanized anti-PD-1 antibody that blocks the binding of PD-1 with its ligands. This activates T-cells (a type of immune cell) and boosts the ability of the immune system to identify and fight tumor cells.

The approval by the Japanese Ministry of Health, Labor and Welfare follows positive data from the KEYNOTE-045 Phase 3 trial (NCT02256436).

The study compared Keytruda with a chemotherapy of choice — Taxol (paclitaxel), Taxotere (docetaxel), Javlor (vinflunine) — in patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy.

It’s primary objective was to determine if Keytruda was better than chemotherapy at improving the time a patient lived without disease worsening and patients’ overall survival. Secondary measures included overall response rate and duration of response.

While no differences were seen in progression-free survival rates, patients who took Keytruda lived for a median of 10.3 months, while those receiving chemotherapy only lived for 7.4 months. This represented a 27 percent reduction in the risk of death.

“Chemotherapy has long been the standard of care for advanced urothelial carcinoma, with few options available for patients whose disease progresses,” Roy Baynes, MD, PhD, senior vice president and head of global clinical development, and chief medical officer at Merck Research Laboratories, said in a press release. “We welcome the approval of Keytruda as the first anti-PD-1 therapy for these patients in Japan based on the compelling overall survival data from KEYNOTE-045.”

Urothelial carcinoma is the most common type of bladder cancer. According to the American Cancer Society, bladder cancer is the fourth most common new cancer in men, and accounts for approximately 5 percent of all new cancers in the U.S.

Besides advanced urothelial carcinoma, Keytruda is indicated for three other types of cancer in Japan, including severe forms of melanoma, lung cancer, and classical Hodgkin lymphoma.

In the U.S., Keytruda is currently indicated to treat patients with locally advanced or metastatic urothelial carcinoma who are not eligible for chemotherapy containing Platinol (cisplatin).

Keytruda is also indicated for patients with locally advanced or metastatic urothelial carcinoma who showed disease progression during or following platinum-containing chemotherapy, or within 12 months of treatment with platinum-containing chemotherapy.

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