Merck's Pembrolizumab in Combination with Lenvatinib and TACE Approved in China for Unresectable, Non-Metastatic Hepatocellular Carcinoma

China Finance Online, June 13th: Today, MSD announced that its PD-1 inhibitor Pembrolizumab (Keytruda) has been approved by the National Medical Products Administration (NMPA), in combination with Lenvatinib and Transarterial Chemoembolization (TACE), for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma.

The approval of this new indication is based on data from the Phase III clinical trial LEAP-012 study.

The latest data released by the National Cancer Center shows that in 2022, China had 367,700 new cases of liver cancer and 316,500 deaths, making it the fourth most commonly diagnosed cancer and the second deadliest cancer in China. From 2012 to 2015, the five-year survival rate for liver cancer patients in China was only 12.1%. Approximately 70% of patients are diagnosed at an advanced stage, having already lost the opportunity for curative surgical resection. Although TACE is currently a crucial treatment method, there remains a significant unmet medical need.

"Pembrolizumab and Lenvatinib Combined with TACE Approved in China for Unresectable Non-Metastatic Hepatocellular Carcinoma, Offering a Significant New Option in the Field of Liver Cancer Treatment and Becoming Another Highly Anticipated Innovative Combination Therapy." Professor Ren Zhenggang, Principal Investigator (PI) of the LEAP-012 study and Chief Physician of the Hepatobiliary Oncology Department at Zhongshan Hospital Affiliated to Fudan University, stated that most patients with hepatocellular carcinoma in China are diagnosed without the opportunity for surgical treatment. The approval of this new indication for Pembrolizumab and Lenvatinib combined with TACE provides another new approach to combat this difficult-to-treat cancer type and offers patients a new treatment option and hope.

"MSD has always been actively exploring ways and possibilities to change cancer treatment and pushing the boundaries of science. Previously, Keytruda (Pembrolizumab Injection) has been approved as a monotherapy for patients with hepatocellular carcinoma who have previously received sorafenib or oxaliplatin-based chemotherapy," said Dr. Li Zhengqing, Senior Vice President of MSD Global and President of MSD China Research and Development Center. He noted that this approval for combination therapy is based on data from the international multicenter clinical trial LEAP-012, in which Chinese patients accounted for 43.3% of the enrolled participants. This marks the first global approval for this indication, providing a new option for the clinical treatment of hepatocellular carcinoma in China.

Anna Tian, Senior Vice President of MSD Global and President of MSD China, stated that from transferring the world's most advanced genetically engineered recombinant hepatitis B vaccine technology to China in 1989, to continuously introducing innovative treatment solutions in recent years, MSD has maintained a long-standing commitment to patients in the field of liver diseases. "The recent approval in China of the combination therapy of pembrolizumab and lenvatinib not only provides more patients with hepatocellular carcinoma access to cutting-edge treatment options but also reaffirms MSD’s value of leveraging frontier science to save lives and improve quality of life."