Express significantly reduces the risk of recurrence after lung cancer surgery, and Keytruda is expected to benefit patients at an earlier stage

▎WuXi AppTec Content Team Editor Recently, Merck & Co.
(MSD), European Organization for Research and Treatment of Cancer (EORTC) and European Thoracic Oncology Platform (ETOP) jointly announced that the blockbuster PD-1 inhibitor Keytruda (pembrolizumab, pembrolizumab) with positive results from an interim analysis of a phase 3 clinical trial
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The trial met one of its dual primary endpoints in patients with stage IB-IIIA non-small cell lung cancer (NSCLC), regardless of PD-L1 expression, who underwent surgical resection with Keytruda compared with placebo.
Disease-free survival (DFS) was significantly improved after treatment
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The safety profile of the drug in the trial was consistent with previous studies
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Specific results will be presented at an upcoming medical meeting and will be submitted to regulatory agencies
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According to the World Health Organization (WHO), in 2020, lung cancer is the leading cause of cancer death worldwide
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Globally, there are more than 2 million new lung cancer cases and 1.
8 million deaths from lung cancer
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Among them, NSCLC accounts for 84% of all lung cancers, and the 5-year survival rate of NSCLC patients with distant metastasis (that is, the spread of tumor cells to other parts of the body) is only 7%
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Surgery is usually the first intervention in patients with early-stage NSCLC, however, the recurrence rate after resection is approximately 43%
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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
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Merck currently has more than 1,600 trials investigating the efficacy of Keytruda in a variety of cancers and treatment settings
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The Phase 3 clinical trial enrolled 1177 patients with stage IB-IIIA NSCLC after surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy, randomized 1:1 to receive Keytruda or placebo
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The dual primary endpoint of the trial was DFS in the overall population and in patients with tumors that expressed high PD-L1 (TPS ≥ 50%)
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Secondary endpoints included overall survival (OS) and lung cancer-specific survival (time from randomization to lung cancer-specific death)
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The interim analysis also showed an improvement in DFS in patients with tumors that expressed high PD-L1 expression in the Keytruda group compared with the placebo group, although this dual primary endpoint did not reach statistical significance
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The trial will continue to analyze DFS in patients whose tumors express high levels of PD-L1 and assess the key secondary endpoint of overall survival
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"Lung cancer is the leading cause of cancer death globally, and early detection and treatment of lung cancer remains critical," said trial co-principal investigator Luis Paz-Ares, Ph.
D.
"The goal of adjuvant therapy is to reduce the risk of cancer recurrence after surgery.

By
advancing Keytruda into an earlier stage of NSCLC, we are expected to reduce the risk of disease recurrence after surgery in patients with stage IB-IIIA NSCLC
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"Reference: [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.
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