Merck’s KEYTRUDA Gains Approval For Stage Non-Small Cell Lung Cancer In China

Merck, known as MSD outside the U.S. and Canada, announced that China’s National Medical Products Administration (NMPA) has approved KEYTRUDA. Merck’s anti-PD-1 therapy is for use in patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). The approval allows KEYTRUDA to be used in combination with platinum-based chemotherapy as a neoadjuvant (pre-surgery) treatment, followed by KEYTRUDA monotherapy as an adjuvant (post-surgery) treatment.

Dr. Heather Wakelee, principal investigator for KEYNOTE-671, thoracic medical oncologist and professor of medicine at Stanford University and past president of the International Association for the Study of Lung Cancer (IASLC), said in a statement, “While there have been several advances in the treatment of metastatic lung cancer over the past decade, lung cancer continues to be the leading cause of cancer death in China. This approval represents an important moment for certain patients with resectable NSCLC in China, providing a new option that has been shown in the KEYNOTE-671 study to significantly improve overall survival in these patients.”

This approval is based on results from the KEYNOTE-671 trial, which previously led to U.S. approval in October 2023. In the study, the KEYTRUDA-based regimen showed significant improvements in overall survival (OS) and event-free survival (EFS) for patients with NSCLC, regardless of PD-L1 expression. The therapy reduced the risk of death by 28% (HR=0.72) compared to placebo plus chemotherapy, with median OS not yet reached for patients on KEYTRUDA versus 52.4 months for those on the placebo-chemotherapy regimen. Additionally, the KEYTRUDA regimen lowered the risk of disease recurrence, progression, or death by 42% (HR=0.58).

Anna Van Acker, Senior Vice President of MSD and President of MSD in China, commented, “This approval marks KEYTRUDA’s fourth lung cancer indication in China, embarking on a new journey of treating certain patients with earlier stage non-small cell lung cancer. KEYTRUDA has established an important role in immunotherapy for advanced NSCLC with its three previously approved indications in China, but there are still significant unmet medical needs for certain patients with earlier stage NSCLC, as lung cancer remains China's leading cause of cancer incidence and mortality. We are thrilled to introduce this new treatment option and remain committed to advancing innovation to help more Chinese patients.”

The safety profile of KEYTRUDA in this patient population was consistent with its use across other cancers in combination with chemotherapy. This latest approval reflects growing global recognition of KEYTRUDA’s benefits in the perioperative setting for early-stage NSCLC. Similar approvals have already been granted in the U.S., European Union, and Japan, highlighting KEYTRUDA’s expanding role in lung cancer treatment worldwide.