Merck’s KEYTRUDA (pembrolizumab) Now Approved as Monotherapy in China for NSCLC

Merck, known as MSD outside the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) as determined by a NMPA-approved test, with no EGFR or ALK genomic tumor aberrations. This new indication was granted full approval based on the overall survival (OS) findings from the Phase 3 KEYNOTE-042 trial, including data from an extension of the global study in Chinese patients. KEYTRUDA is now the first anti-PD-1 therapy approved in China as both monotherapy and in combination with chemotherapy for the first-line treatment of appropriate patients with NSCLC.

“New treatment options that can help improve survival outcomes are desperately needed in China, as lung cancer remains the leading cause of cancer deaths in this country,” said Professor Yi-Long Wu, honorary director of the Guangdong Lung Cancer Research Institute, and tenured professor of Guangdong Provincial People’s Hospital. “In KEYNOTE-042, KEYTRUDA monotherapy demonstrated a survival benefit, compared with chemotherapy alone, across histologies in patients with either locally advanced or metastatic non-small cell lung cancer whose tumors expressed PD-L1 in at least 1% of tumor cells.”

KEYNOTE-042 is an international, randomized, multi-center, open-label, active-controlled trial in patients with stage III NSCLC who were not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors expressed PD-L1 (TPS ≥1%) and who had not received prior systemic treatment for metastatic NSCLC. In the extension of the global study in Chinese patients, KEYTRUDA monotherapy demonstrated a statistically significant improvement in OS compared with chemotherapy in patients whose tumors expressed PD-L1 with a TPS ≥50% (HR=0.62 [95% CI, 0.38-1.00]), with a TPS ≥20% (HR=0.62 [95% CI, 0.41-0.95]) and in the entire study population with a TPS ≥1% (HR=0.65 [95% CI, 0.45-0.94]). Results from the KEYNOTE-042 China extension study were recently presented for the first time at the IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer and showed consistent results in Chinese patients.

“KEYTRUDA is now the first anti-PD-1 therapy approved in China as both a monotherapy and in combination with chemotherapy in the first-line setting for appropriate patients with advanced non-small cell lung cancer,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “For patients for whom combination therapy is not preferred, KEYTRUDA monotherapy represents an important new treatment option that has demonstrated a significant improvement in survival outcomes.”

“In China, we launched KEYTRUDA one year ago, and already it has had an impact on patient care in the approved indications,” said Joseph Romanelli, president of MSD in China. “Now, with a third indication in China, we look forward to offering an additional effective option in non-small cell lung cancer patients with PD-L1 levels of 1% or greater.”