Keytruda Receives China Approval for First-Line Monotherapy in PD-L1-Positive NSCLC

By Zhang Hongli

Today (September 30), the National Medical Products Administration updated the application status of Merck’s PD-1 antibody Keytruda (pembrolizumab) to “Approval Completed – Pending Certificate Issuance,” marking the formal approval of Keytruda as a monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in all patients with PD-L1–positive tumors and no EGFR or ALK mutations. This approval represents the first time an immune checkpoint inhibitor has been approved as a standalone first-line therapy for lung cancer (including both adenocarcinoma and squamous cell carcinoma) in China, coming just over five months after its approval in the United States.

This also marks the third indication approved for Keytruda in China. Previously, the drug had been approved in China for melanoma and, in combination with chemotherapy, for first-line treatment of non-small cell lung adenocarcinoma. Notably, its approval as monotherapy for first-line treatment of lung cancer (both adenocarcinoma and squamous cell carcinoma) came just over five months after that in the United States.

It is understood that this approval was based on the data results from the Phase III clinical trial KN042. In April 2018, Merck Sharp & Dohme (MSD) announced that an interim analysis of the KN042 study showed that Keytruda significantly improved overall survival in patients with PD-L1 expression >1% compared to platinum-based chemotherapy, which was the primary endpoint of the trial. The trial sequentially compared the overall survival (OS) benefits of Keytruda versus chemotherapy in populations with PD-L1 expression in ≥50%, ≥20%, and ≥1% of tumor cells, and the results demonstrated that Keytruda outperformed chemotherapy in all PD-L1-positive populations.

Immunotherapy comes in various forms, but for non-small cell lung cancer (NSCLC) without sensitive gene mutations, the greatest current hope lies in PD-1 inhibitors. These drugs act on the patient’s own immune system, exerting their therapeutic effect by reactivating the immune response against tumors.

In recent years, immunotherapies represented by Keytruda (pembrolizumab) and Opdivo (nivolumab) have been steadily transforming the standard of care for lung cancer, progressing from second-line therapy to first-line combination therapy, and further to first-line monotherapy.

This means that some patients who are intolerant to chemotherapy may no longer require combination chemotherapy and can instead try immunotherapy alone, which will bring significant changes to lung cancer treatment. It is reported that patient assistance programs will also soon expand their scope of eligibility.