Merck KGaA Discontinues Phase 3 Trial of Bintrafusp Alfa in Patients with Non-Small Cell Lung Cancer

Merck KGaA Discontinues Phase 3 Trial of Bintrafusp Alfa in Patients with Non-Small Cell Lung Cancer

Merck KGaA announced the ongoing [email protected] Lung 037 clinical trial, evaluating bintrafusp alfa as the first-line treatment of patients with stage IV non-small-cell lung cancer (NSCLC) that have high expression of PD-L1, will be discontinued. While reviewing the totality of data from the trial, the Independent Data Monitoring Committee recommended the trial be discontinued, as it is unlikely to meet the co-primary endpoint, specifically progression-free survival. Based on this recommendation, Merck KGaA, Darmstadt, Germany, has made the decision to discontinue the clinical trial.

The multicenter, randomized, open-label, controlled study was designed to evaluate the efficacy and safety of bintrafusp alfa (M7824), compared with pembrolizumab (Keytruda) in patients with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allowed for the option to recruit up to 584 patients based on pre-specified rules.

In February of 2019, Merck and GlaxoSmithKline entered into a global strategic alliance to jointly develop and commercialize bintrafusp alfa. The p...

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