Merck's Keytruda Demonstrates Significant Improvement in Disease-Free Survival as Adjuvant Therapy in Stage IB-IIIA NSCLC Regardless of PD-L1 Expression

Recently, MSD, the European Organisation for Research and Treatment of Cancer (EORTC), and the European Thoracic Oncology Platform (ETOP) jointly announced positive interim results from a phase 3 clinical trial of the重磅 PD-1 inhibitor Keytruda (pembrolizumab). The trial met one of its dual primary endpoints, showing that Keytruda significantly improved disease-free survival (DFS) in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) after surgical resection compared to placebo, regardless of PD-L1 expression. The safety profile of the drug was consistent with previous studies. Detailed results will be presented at an upcoming medical conference and submitted to regulatory authorities.

According to statistics from the World Health Organization (WHO), in 2020, lung cancer was the leading cause of cancer-related deaths globally. There were over 2 million new cases of lung cancer worldwide, with 1.8 million deaths attributed to the disease. Among these, non-small cell lung cancer (NSCLC) accounted for 84% of all lung cancer cases. The 5-year survival rate for NSCLC patients with distant metastases (i.e., where cancer cells have spread to other parts of the body) is only 7%. Surgery is typically the first line of intervention for patients with early-stage NSCLC; however, the post-surgical recurrence rate is approximately 43%.

Keytruda is an anti-PD-1 monoclonal antibody therapy that blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2, thereby activating T lymphocytes. MSD currently has over 1,600 trials studying the efficacy of Keytruda across various cancers and treatment settings.

This Phase 3 clinical trial enrolled 1,177 patients with Stage IB-IIIA NSCLC who had undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy. Patients were randomized 1:1 to receive either Keytruda or placebo. The dual primary endpoints were DFS in the overall population and in patients with high PD-L1 expression (TPS ≥50%). Secondary endpoints included overall survival (OS) and lung cancer-specific survival (time from randomization to lung cancer-specific death).

The interim analysis also showed that DFS was improved in patients with tumors highly expressing PD-L1 in the Keytruda group compared to the placebo group, but this dual primary endpoint did not reach statistical significance. The trial will continue to analyze DFS in patients with tumors expressing high levels of PD-L1 and evaluate the key secondary endpoint, overall survival.

References:

[1] Merck’s Keytruda® (pembrolizumab) Showed Statistically Significant Improvement in Disease-Free Survival Versus Placebo as Adjuvant Treatment for Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Regardless of PD-L1 Expression. Retrieved January 10, 2022, from https://www.businesswire.com/news/home/20220110005297/en

(Original text has been abridged)

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