“K Drug” Pembrolizumab Approved in China for New Indications for Hepatocellular Carcinoma Treatment

Recently, the PD-1 inhibitor pembrolizumab (commonly known as “K drug” in China, trade name: Keruida) has another indication in China! The China National Medical Products Administration (NMPA) has approved pembrolizumab as a monotherapy for the treatment of patients with hepatocellular carcinoma (HCC) who have previously received sorafenib or oxaliplatin-containing chemotherapy. This is the ninth indication for pembrolizumab approved in China since it was first approved for marketing in China in 2018.

According to data from the World Health Organization, there will be about 410,000 new cases of liver cancer in China in 2020, accounting for about 45% of the global total. In the same year, there were about 391,000 deaths from liver cancer in China, second only to lung cancer and the highest The second leading cause of cancer deaths in my country. Due to the insidious onset of liver cancer and no specific symptoms in the early stage, most patients have lost the opportunity for surgery when they are discovered. Data show that 70%-80% of liver cancer patients in my country are already in the middle and late stages at the time of diagnosis.

In the systemic treatment of liver cancer, chemotherapy and targeted drugs have shown new breakthroughs in first-line treatment in the past 20 years, but for patients who fail first-line treatment, there is still a lack of patients who can prolong Survival benefit treatment options.

The approval of this new indication is based on data from the Phase III KEYNOTE-394 study, which showed that compared with patients in the placebo group, pembrolizumab treatment The overall survival of patients with advanced liver cancer after treatment has been significantly improved. The median survival time was 14.6 months, and the risk of death was reduced by 21%. It is the longest overall survival period of monotherapy in the current second-line liver cancer research.

The principal investigator of the KEYNOTE-394 study, professor of Nanjing University of Traditional Chinese Medicine, and director of the Cancer Center of Nanjing Jinling Hospital, Professor Qin Shukui, said, “Currently, patients with advanced hepatocellular carcinoma have relatively poor survival benefits after treatment. There is still a huge medical need that needs to be met urgently. The approval of the new indication of pembrolizumab provides a new ‘weapon’ for the fight against hepatocellular carcinoma, a refractory cancer, and also provides a new ‘weapon’ for clinicians and Patients offered new treatment options.”

Merck & Co. Global Senior Vice President and Merck China President Anna Tian said, “For a long time, Merck has been committed to the field of liver disease and has a rich pipeline from prevention to treatment. The approval of the ninth indication of pembrolizumab in China will provide more advanced treatment options for hepatocellular carcinoma patients.”

[Reporter] Ou Xujiang

【Author】 Ou Xujiang

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