Merck KGaA and GSK have agreed to jointly develop and commercialize M7824 (bintrafusp alfa). M7824 is an investigational bifunctional fusion protein immunotherapy that is currently in clinical development, including potential registration studies, for multiple difficult-to-treat cancers.
This deal includes a phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC.
M7824 is designed to simultaneously target two immuno-suppressive pathways, transforming growth factor-β trap and an anti-programmed cell death ligand-1, that are commonly used by cancer cells to evade the immune system. Bifunctional antibodies aim to increase efficacy above and beyond that achieved with individual therapies or combinations of individual therapies. M7824 has the potential to offer new ways to fight difficult-to-treat cancers beyond the established PD-1/PD-L1 class. In addition to use as a single agent, M7824 is also being considered for use in combination with other assets from the pipelines of both companies.
Merck KGaA will receive an upfront payment of €300 million and is eligible for potential development milestone payments of up to €500 million triggered by data from the M7824 lung cancer program.
Merck KGaA will also be eligible for further payments upon successfully achieving future approval and commercial milestones of up to €2.9 billion. The total potential deal value is up to €3.7 billion. Both companies will jointly conduct development and commercialization with all profits and costs from the collaboration being shared equally on a global basis.
Bintrafusp alfa is the proposed International Nonproprietary Name for the bifunctional immunotherapy M7824. Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.
M7824 is an investigational bifunctional immunotherapy that is designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. M7824 is designed to combine co-localized blocking of the two immuno-suppressive pathways—targeting both pathways aims to control tumor growth by potentially restoring and enhancing anti-tumor responses.
M7824 is currently in phase I studies for solid tumors, as well as a randomized phase II trial to investigate M7824 compared with pembrolizumab as a first-line treatment in patients with PD-L1 expressing advanced NSCLC. The multicenter, randomized, open-label, controlled study is evaluating the safety and efficacy of M7824 versus pembrolizumab as a monotherapy treatment.
To-date, nearly 700 patients have been treated with M7824 across more than 10 tumor types in phase I studies. Encouraging data from the ongoing phase I studies indicates M7824’s potential safety and clinical anti-tumor activity across multiple types of difficult-to-treat cancers, including advanced NSCLC, human papillomavirus-associated cancers, biliary tract carcinoma and gastric cancer.
In addition, in pre-clinical studies M7824 demonstrated superior anti-tumor activity, compared with anti-PD-L1 alone or with anti-PD-L1 and TGF-β trap when co-administered. In total, eight high priority immuno-oncology clinical development studies are ongoing or expected to commence in 2019, including studies in NSCLC and biliary tract cancers.
