China NMPA approves KEYTRUDA for NSCLC stages

China's National Medical Products Administration (NMPA) has approved the use of MSD's KEYTRUDA, in combination with chemotherapy, as a neoadjuvant treatment for resectable stages II, IIIA, or IIIB non-small cell lung cancer (NSCLC). Following surgery, KEYTRUDA will also be available as a standalone treatment. This approval is particularly significant as it represents the first time KEYTRUDA is sanctioned for earlier stages of NSCLC in China, complementing its previous three approved indications for this cancer type.

This decision from the NMPA comes shortly after U.S. approval, which was granted in October 2023. The basis for these approvals is the findings from the KEYNOTE-671 clinical trial. In this study, participants with NSCLC receiving KEYTRUDA alongside chemotherapy showed markedly improved survival outcomes. Specifically, the treatment led to a 28% reduction in the risk of death compared to those who received a placebo with their chemotherapy. Furthermore, the median overall survival (OS) for patients treated with the KEYTRUDA regimen was not reached, indicating a potentially longer survival time, compared to 52.4 months for the placebo-chemotherapy group.

In addition to improved overall survival, KEYTRUDA also demonstrated a 42% improvement in event-free survival (EFS), reflecting a reduced risk of disease progression, recurrence, or mortality. The side effects observed with the KEYTRUDA-chemotherapy combination were consistent with those seen across different tumor types when using similar combination therapies.

The recent approval in China is another step in KEYTRUDA's expanding global presence for the perioperative treatment of early-stage NSCLC. It follows endorsements from other major health authorities, including Japan and the European Union.

Anna Van Acker, the president of MSD China and senior vice-president of MSD, expressed that this new indication for KEYTRUDA marks a significant milestone in treating early-stage non-small cell lung cancer in China. She highlighted the critical role that KEYTRUDA has already played in the realm of immunotherapy for advanced stages of NSCLC through its previously approved uses in the country. However, she also acknowledged the considerable unmet medical needs that remain for patients with earlier-stage NSCLC, as lung cancer continues to be the leading cause of cancer-related deaths and incidence in China.

Beyond its recent approval in China and the U.S. for early-stage NSCLC, KEYTRUDA received approval in September 2024 from the U.S. Food and Drug Administration (FDA) for use as a first-line treatment for adults with unresectable advanced or metastatic malignant pleural mesothelioma. This further broadens KEYTRUDA's application across various cancer types and stages, reinforcing its significance in cancer therapy.

The ongoing endorsements across different regions and cancer stages highlight the importance of KEYTRUDA in the evolving landscape of cancer treatment, offering hope for improved outcomes for patients worldwide. As research continues and new evidence emerges, KEYTRUDA is likely to play an ever-increasing role in oncology, addressing both current and future medical needs in the fight against cancer.