- Merck KGaA's MKGAF announced that a Phase 2 trial of bintrafusp alfa had been discontinued, as an independent data monitoring committee has determined the study is unlikely to meet its goal of improving overall survival.
- The INTR@PID BTC 055 trial examined the drug as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer combined with the chemotherapy drugs cisplatin and gemcitabine.
- The decision to discontinue is the third strike on bintrafusp alfa, with the future of the therapy uncertain.
- Merck discovered the therapy in-house but developed it with GlaxoSmithKline plc GSK through the $4.2 billion deal.
- Strike two came in March when an independent review of the INTR@PID BTC 047 study determined that bintrafusp alfa caused an objective response rate of just 10.1%. This efficacy was too low to support a regulatory filing.
- But Merck was not ready to abandon the asset, pointing to the BTC 055 study.
- Two months earlier was the first strike. Bintrafusp alfa failed in a head-to-head matchup with Merck & Co Inc's MRK blockbuster cancer therapy Keytruda.
- Price Action: MKGAF stock closed at $234.49 on Monday, while GSK stock is down 0.92% at $41.11 during the premarket session on the last check Tuesday.
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