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Merck KGaA Discontinues Phase III Lung Cancer Trial of Bintrafusp Alfa

NEW YORK – Merck KGaA on Wednesday said it will stop the Phase III [email protected] Lung 037 trial, within which it was exploring the activity of its investigational bifunctional immunotherapy, bintrafusp alfa, in stage IV non-small lung cancer patients with high PD-L1 expression.

In the trial researchers were comparing the safety and efficacy of bintrafusp against pembrolizumab (Merck's Keytruda) as a first-line option in PD-L1-high, advanced NSCLC. During the recent JP Morgan Healthcare Conference, Hal Barron, CSO of GlaxoSmithKline, which is co-developing bintrafusp with Darmstadt, Germany-based Merck KGaA in this setting, noted that if this study demonstrated the superiority of bintrafusp over pembrolizumab in this setting, then it could be a "game changer." 

However, an independent data monitoring committee, after reviewing the data in [email protected] Lung 037, recommended Merck KGaA discontinue the study because it is unlikely to meet its coprimary endpoints of progression-free and overall survival. Danny Bar-Zohar, global head of development for Merck KGaA's healthcare business, said in a statement that the company will learn from [email protected] Lung 037 and apply the insights to other ongoing studies, including those exploring the activity of the drug in combination with other therapies in lung cancer patients.