The approval marks the first indication of MSD’s KEYTRUDA in the earlier stages of NSCLC in China. Credit: JHVEPhoto/Shutterstock.

China National Medical Products Administration (NMPA) has approved MSD’s KEYTRUDA for use in conjunction with platinum-containing chemotherapy as a neoadjuvant treatment and as a single agent post-surgery for resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC).

The approval marks the first indication for the anti-programmed cell death protein 1 (PD-1) therapy in the earlier stages of this NSCLC in China, adding to its previous three indications for this type of cancer.

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The decision by the NMPA follows US approval in October 2023, based on the outcomes from the KEYNOTE-671 trial.

The trial demonstrated that KEYTRUDA combined with chemotherapy significantly improved overall survival (OS) in NSCLC subjects, decreasing mortality risk by 28% compared to the placebo combined with the chemotherapy regimen.

Recipients of the therapy-based regimen showed a median OS that was not reached, in contrast to 52.4 months for those on the chemotherapy-placebo regimen.

The KEYTRUDA regimen improved event-free survival (EFS) by 42%, indicating a lower risk of disease progression, recurrence or death.

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The adverse events observed were similar to those seen in subjects across tumour types receiving the combination therapy.

The latest approval in China adds to the growing list of global endorsements for KEYTRUDA in the perioperative treatment of certain earlier stages of NSCLC, including from Japan and the European Union.

MSD China president and MSD senior vice-president Anna Van Acker stated: “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.”

In September 2024, the US Food and Drug Administration (FDA) approved the use of KEYTRUDA as a first-line treatment for the adult population with unresectable advanced or metastatic malignant pleural mesothelioma.