Keytruda Becomes the First Anti-PD-1 Therapy Approved in China for Advanced Melanoma

Merck (NYSE:MRK) announced on 7/26/18 that Keytruda, Merck’s anti-PD-1 therapy, has been approved by the China National Drug Administration (CNDA) for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first and only approval of an anti-PD-1 therapy for advanced melanoma in China.

“Over the past decades, we have had limited effective options in the treatment of patients with advanced melanoma,” Professor Jun Guo, M.D., Ph.D, director of the Department of Melanoma & Renal Cancer, Peking University Cancer Hospital and Institute Secretary-General of the Chinese Society of Clinical Oncology, primary investigator, KEYNOTE-151. “Advanced melanoma is one of the cancers that has been most responsive to immunotherapy, and outside of China, anti-PD-1 therapies such as pembrolizumab have become the standard therapy for this disease. With the approval of pembrolizumab in China, the treatment of advanced melanoma will now be aligned with international standards.”

The approval of Keytruda in China was based on overall response rate (ORR) data from the Phase 1b KEYNOTE-151 study, which evaluated Keytruda monotherapy in Chinese patients with previously treated locally advanced or metastatic melanoma who received one prior line of systemic therapy. In 2018, the CNDA granted priority review status to Keytruda, which accelerated the approval process by allowing for simultaneous clinical validation for the first time – creating an industry leading approval turnaround time for imported cancer medicine in China.

Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck may soon have additional competition in the PD-1 inhibitor arena. BeiGene recently initiated PH III trials of its PD-1 inhibitor, tislelizumab in China.