Merck/GSK terminated the M7824 phase 3 head-to-head study of the treatment of lung cancer in Keytruda, Bethesda

On January 20th Merck KGaA, the German pharmaceutical giant, announced the latest developments in the study of bintrafusp alfa (M7824) lung cancer Phase 3 INTR@PID Lung 037 and updated the INTR@PID clinical trial project.
Bintrafusp alfa is a pioneering two-functional immunotherapy that combines a transformational growth factor-β (TGF-β) trap with an anti-PF-L1 mechanism in a fusion protein designed to bind to common local blocking of two immunosuppressive pathways, while targeting these two pathways to control tumor growth by potentially restoring and enhancing the anti-tumor response.
February 2019, GlaxoSmithKline and Merck signed a $4.2 billion global cooperative development agreement to advance bintrafusp alfa's development in refraculable cancer.
deal comes after GlaxoSmithKline's $5.1bn acquisition of Tesaro comes at a time when the company is undergoing a period of major restructuring, research and development transfer, and is once again focusing on oncology.
INTR@PID project aims to assess the efficacy of bintrafusp alfa in tGF-β cancer-driven cancer and treatment environments.
TGF-β is a cytokine that is associated with tumor proliferation and metastasis through a variety of mechanisms, such as local immunosuppression, fibrosis, tumor vascular growth and chemotherapy or radiotherapy resistance.
based on PD-L1 blockers, the capture of TGF-β in tumor microentastic environments is considered to have transformational effects in different clinical environments.
INTR@PID clinical trial project is evaluating the potential of bintrafusp alfa to treat a variety of incurable cancers, including bile tube cancer (BTC) and cervical cancer.
of these, INTR@PID Lung 037 studies are evaluating patients with highly expressed stage IV non-small cell lung cancer (NSCLC) in bintrafusp alfa first-line treatment, in direct comparison with the Mercadon anti-PD-1 therapy Keytruda.
's announcement, Merck said that after reviewing all data from the NINTR@PID Lung 037 study, the Independent Data Monitoring Board recommended on January 19, 2021 that the clinical trial be discontinued because it was unlikely to reach the common primary endpoint of progress-free lifetime (PFS).
based on this recommendation, Merck decided to discontinue INTR@PID Lung 037 study.
said the independent data monitoring committee's recommendations and the company's decision were only relevant to the clinical trial.
, other INTR@PID trials of the project are currently under way.
, head of global development for Merck Healthcare, said: "We pioneered the science behind bintrafusp alfa and are now evaluating the treatment of a wide range of types of cancer in INTR@PID projects through a strategic alliance.
we remain committed to further evaluating bintrafusp alfa, and data from INTR@PID Lung 037 research will provide important insights that could be applied to future research.
" Reference Source: GSK, German Merck's $4.2B bintrafusp alfa drug a bust, fails to beat beat king Keytruda in lung cancer