Upgraded PD-1! Merck's dual-function tumor immunotherapy in Germany has been approved for clinical practice.

Merck KGaA has been granted implicit approval for clinical trials of new anti-tumor drugs (code m7824) for the treatment of non-small cell lung cancer (NSCLC), according to the latest announcement from the Drug Review Center (CDE) of the National Drug Administration. The drug has been approved by the FDA in the United States as a dual-function immunotherapy M7824 orphan drug for the treatment of bile duct cancer. In February, GlaxoSmithKline (GSK) struck a global deal with Germany's Merck, which could receive payments totalling 3.7 billion euros.
M7824 is known as the "Upgraded PD-1 Antibody", a dual-functional fusion protein that simultaneously targets PD-L1 and conversion growth factor-beta (TGF-beta) and improves cancer treatment efficiency and reduces side effects of combination drugs.
based on published clinical studies, the treatment has great potential in many areas of cancer treatment.
in Phase 1 trials, M7824 was used to treat nearly 700 patients and included more than 10 tumor types. It shows clinical anti-cancer activity in the treatment of refracted cancers including advanced non-small cell lung cancer, hpv-related cancers, bile duct cancer (BTC) and stomach cancer. Currently, it is used as a first-line therapy in Phase 2 clinical trials to treat patients with advanced non-small cell lung cancer expressing PD-L1.
The results of clinical trials of M7824 for non-small cell lung cancer, presented at the 2018 ASCO Annual Meeting. In the non-small cell lung cancer patient population, this innovative treatment achieved good results - in the PD-L1-positive population (PD-L1 is not less than 1%), the overall remission rate (ORR) of the new drug reached 40.7%. In the patient population with high expression of PD-L1 (PD-L1 is not less than 80%), m7824 has an ORR of 71.4%.
Meanwhile, on December 10, 2018, Merck announced that the U.S. Food and Drug Administration (FDA) has granted it the qualification of dual-functional immunotherapy M7824 for the treatment of bile duct cancer. This is also the first time that dual-functional immunotherapy has been earmarked for the treatment of bile duct cancer.
in February, GlaxoSmithKline and Germany's Merck jointly announced a global cooperation agreement to jointly develop and promote m7824 (bintrafusp alfa). Under the cooperation agreement, Merck will receive an up-front payment of 300 million euros, and Merck germany may receive a total of 3.7 billion euros under the research and development and promotion process. The two sides will jointly develop and promote the product and share the global benefits of the product.
References: (1) GSK and Merck KGaA, Darmstadt, Germany announce global alliance to jointly develop and commercialise M7824, a novel-brandrapythe potential with in multiple-tha-court-to-cancer
.