Merck Announces First-Ever China-Specific Results from Phase III KEYNOTE-042 Trial of Pembrolizumab in First-Line NSCLC

SHANGHAI, Sept. 11, 2019 /PRNewswire/ -- MSD (known as Merck in the United States and Canada) announced the results from the Chinese subgroup and the Chinese expansion cohort of the Phase III clinical trial KEYNOTE-042.。This study aims to evaluate the efficacy of Merck Sharp & Dohme’s PD-1 inhibitor pembrolizumab compared with chemotherapy in previously untreated PD-L1-positive (TPS>=1%) and no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) patient efficacy. The study results were presented at the 2019 World Conference on Lung Cancer viaKEYNOTE-042 Professor Wu Yilong, China Principal Investigator, Honorary Director of the Guangdong Lung Cancer Institute, and Lifetime Chief Physician at Guangdong Provincial People's HospitalReleased.

Lung Cancer RanksChinathe leading cause of cancer incidence and mortality in China,CountryLatest Statistical Data from the National Cancer Center：2015ChinaChina: Approximately 787,000 New Lung Cancer Cases and 631,000 Lung Cancer Deaths^[1]. Most patients are diagnosed at an advanced stage, and the five-year survival rate for advanced lung cancer is only about 5%.^[2], the current treatment landscape urgently needs improvement. “KEYNOTE-042 is among PD-1 inhibitors in terms of overall survival (OS) "Studies of monotherapy as first-line treatment for NSCLC with the primary endpoint,"Professor Wu Yilong stated, “This subgroup and expanded cohort analysis isFirst“The release of research data on the use of PD-1 inhibitors as first-line monotherapy in patients with locally advanced or metastatic NSCLC in China is of great significance.”

KEYNOTE-042 is an international, multicenter, randomized, open-label Phase III study. The Chinese subgroup (92 patients) and the Chinese expansion cohort (170 patients) collectively enrolled 262 Chinese patients with PD-L1–positive locally advanced or metastatic non-small cell lung cancer (NSCLC), who were randomized to receive either pembrolizumab (128 patients) or platinum-based chemotherapy (134 patients). The primary endpoint for this analysis of the Chinese population was consistent with that of the overall study, namely, efficacy across different levels of PD-L1 expression (TPS>=50%、TPS>=20%、TPS>=1%) patient population to determine the OS benefit of pembrolizumab in the Chinese population and its consistency with the overall study results.

“As a leader in the field of cancer immunotherapy, MSD is continuously striving globally to advance the science of cancer immunology through large-scale clinical studies involving more than 30 types of cancer,”Dr. Li Zhengqing, Global Vice President of MSD and General Manager of MSD China R&D Center, stated“The medical needs of cancer patients in China urgently need to be addressed. China is also a key player in the research and development of oncology immunotherapy. We will continue to collaborate with more Chinese researchers, aiming to better benefit Chinese patients through research trial results that are closely aligned with their needs.”

As of now, the National Medical Products Administration of China (NMPA) The approved indications for pembrolizumab 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 EGFR mutation-negative and ALK-negative. Pembrolizumab is used for PD-L1 positive (TPS>=1%) and the indication for first-line monotherapy in locally advanced or metastatic NSCLC with negative EGFR/ALK gene mutations has not yet been approved by the NMPA.

[1] Zheng Rongshou, Sun Kexin, Zhang Siwei, et al. Analysis of the prevalence of malignant tumors in China in 2015. Chinese Journal of Oncology [J], 2019, 41(1)

[2] "Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2018 Edition)"