Merck Reports KEYNOTE-181 China Subgroup Results at ESMO 2019, Highlighting Pembrolizumab’s Survival Benefit in Advanced Esophageal Cancer

ShanghaiOctober 8, 2019/PRNewswire/ -- Merck & Co., Inc. (known as MSD outside the United States and Canada) presented data from the Chinese subgroup of the Phase III KEYNOTE-181 clinical trial at the 2019 European Society for Medical Oncology (ESMO) Congress. The study aimed to evaluate the efficacy of Merck’s PD-1 inhibitor pembrolizumab versus chemotherapy in patients with recurrent locally advanced or metastatic esophageal or gastroesophageal junction cancer.

According to the latest cancer report released by the National Cancer Center, China reported 246,000 new cases of esophageal cancer and 188,000 deaths. The incidence and mortality rates ranked sixth and fourth, respectively, among all malignant tumors, accounting for approximately half of the global total.^[1]“In China, esophageal cancer is predominantly squamous cell carcinoma, accounting for more than 90% of cases, whereas adenocarcinoma is more common in Europe and the United States.”^[2] “Therefore, Chinese patients differ significantly from Western patients in terms of pathological type, site of onset, clinical features, and response to treatment,” stated Professor Shen Lin, Principal Investigator for the KEYNOTE-181 study in China, Vice President of Peking University Cancer Hospital, and Director of the Department of Gastrointestinal Medical Oncology. “Currently, the standard of care for esophageal cancer is primarily chemotherapy, but it is associated with low response rates and suboptimal efficacy. The data from the Chinese subgroup in this study are”First“Research data on the use of PD-1 inhibitors as second-line monotherapy in patients with locally advanced or metastatic esophageal cancer in China hold significant implications for the treatment landscape of this malignancy, which exhibits marked differences between Eastern and Western populations.”

KEYNOTE-181 is an international, multicenter, randomized, controlled, open-label Phase III clinical study. The Chinese sub-study enrolled a total of 123 Chinese patients with recurrent locally advanced or metastatic esophageal cancer, who were randomized to receive either pembrolizumab (n=62) or chemotherapy (n=61). The primary endpoints for this analysis of the Chinese population were consistent with those of the overall study, namely the intention-to-treat (ITT) population, the esophageal squamous cell carcinoma population, and the PD-L1 CPS>=10. OS in the Chinese population to assess the overall survival benefit of pembrolizumab and its consistency with the overall study results.

“As a leader in the field of cancer immunotherapy, MSD will continue to deepen its commitment to oncology immunology, challenge various refractory tumors, and help drive progress in the discipline of cancer immunotherapy,” said Dr. Li Zhengqing, Global Vice President of MSD and General Manager of MSD China R&D Center. “The medical needs of Chinese cancer patients are urgent, and China is also a very important participant in the research and development of cancer immunotherapy. We will continue to collaborate with more Chinese research institutions to better benefit Chinese patients through clinical trials that are closer to their needs.”

As of now, the indications for pembrolizumab approved by the National Medical Products Administration (NMPA) of China are for the treatment of unresectable or metastatic melanoma after failure of first-line therapy, and in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) that is negative for EGFR gene mutations and ALK. The indication for pembrolizumab in recurrent locally advanced or metastatic esophageal cancer has not yet been approved by the NMPA.

^[1]Analysis of the Epidemic Status of Malignant Tumors in China in 2015, Chinese Journal of Oncology, Volume 41, Issue 1, 2019

^[2]Standard for Diagnosis and Treatment of Esophageal Cancer (2018 Edition)