Merck KGaA's Bifunctional Cancer Immunotherapy M7824 Granted Clinical Trial Approval in China Following Global Collaboration with GSK

Pharma Insights / Report

Yesterday, the latest public notice from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration announced that the clinical trial application for Merck KGaA’s investigational new anti-tumor drug (code: M7824) for the treatment of non-small cell lung cancer (NSCLC) has received implicit approval. In February this year, GlaxoSmithKline (GSK) entered into a global collaboration agreement with Merck KGaA for this drug, under which the latter may receive total payments amounting to €3.7 billion.

▲ Source: CDE Official Website

M7824 is a novel bifunctional fusion protein that combines a TGF-β trap with an anti-PD-L1 mechanism. It aims to restore and enhance the body’s anticancer response by simultaneously blocking two immunosuppressive signaling pathways. In preclinical studies, M7824 demonstrated superior anticancer activity compared with either anti-PD-L1 antibodies alone or the combination of anti-PD-L1 antibodies and a TGF-β trap.

M7824 has been used to treat nearly 700 patients in Phase I trials, encompassing more than 10 tumor types. It has demonstrated clinical antitumor activity in the treatment of refractory cancers, including advanced non-small cell lung cancer (NSCLC), human papillomavirus (HPV)-associated cancers, biliary tract cancer (BTC), and gastric cancer. Currently, it is being evaluated in Phase II clinical trials as a first-line therapy for patients with advanced NSCLC expressing PD-L1.

Lung cancer ranks first globally and in China in terms of both incidence and mortality among all malignant tumors. In 2015, there were 787,000 new cases and 631,000 deaths from lung cancer in China. Non-small cell lung cancer (NSCLC) accounts for 85% of all lung cancer cases, with the majority diagnosed at an advanced stage. Meanwhile, a considerable proportion of patients with early-stage NSCLC who undergo surgical treatment experience recurrence or distant metastasis, ultimately leading to death due to disease progression. In recent years, the application of small-molecule tyrosine kinase inhibitors (TKIs), anti-angiogenic agents, and immune checkpoint inhibitors has significantly improved patient survival.

Previously, the clinical trial results of M7824 for non-small cell lung cancer (NSCLC) were presented at the 2018 ASCO Annual Meeting. This innovative therapy demonstrated favorable efficacy in patients with NSCLC—achieving an overall response rate (ORR) of 40.7% in the PD-L1-positive population (PD-L1 ≥1%). Notably, in patients with high PD-L1 expression (PD-L1 ≥80%), the ORR for M7824 reached as high as 71.4%!

Dr. Hal Barron, CEO and President of R&D at GSK, stated, “Many patients with refractory cancers currently do not benefit from existing cancer immunotherapies. M7824 combines two distinct biological functions into a single molecule and has demonstrated promising anticancer efficacy in clinical trials, with particularly significant effects in patients with non-small cell lung cancer (NSCLC). I am very excited about the potential benefits this first-in-class immunotherapy may bring to cancer patients.”

Congratulations to Merck KGaA on the approval of its bispecific tumor immunotherapy for clinical trials in China. We look forward to further advancement of clinical research, bringing benefits to more cancer patients at an earlier date.

Source:

[1]GSK and Merck KGaA, Darmstadt, Germany announceglobalalliance to jointly develop andcommercialiseM7824,a novelimmunotherapy with potential in multiple difficult-to-treat cancers. Retrieved February 5, 2019, from https://www.gsk.com/en-gb/media/press-releases/gsk-and-merck-kgaa-darmstadt-germany-announce-global-alliance-to-jointly-develop-and-commercialise-m7824-a-novel-immunotherapy-with-potential-in-multiple-difficult-to-treat-cancers/

[2] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 13, 2019, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25#

Original Title:Merck KGaA’s Bispecific Tumor Immunotherapy Approved for Clinical Trials in China; Previously Reached €3.7 Billion Collaboration with GSK

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