Drug Profile

Bintrafusp alfa - EMD Serono/Merck

Alternative Names: Anti-PD-L1/TGFbetaRII-fusion-protein; Anti-PDL1/TGFb Trap MSB0011359C; GSK-4045154; M-7824; MSB-0011359C

Latest Information Update: 07 Jul 2026

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At a glance

Originator EMD Serono; Merck KGaA
Developer Bergonie Institute; EMD Serono; EMD Serono Research & Development Institute; GSK; M. D. Anderson Cancer Center; Merck KGaA; National Cancer Institute (USA); Precigen Inc; University of Hong Kong; Yonsei University
Class Antineoplastics; Immunotherapies; Monoclonal antibodies; Recombinant fusion proteins
Mechanism of Action Antibody-dependent cell cytotoxicity; B7-H1 antigen inhibitors; Cytotoxic T lymphocyte stimulants; Natural killer cell stimulants; Transforming growth factor beta inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

Discontinued Anal cancer; Biliary cancer; Brain metastases; Breast cancer; Cervical cancer; Colorectal cancer; Gastric cancer; HER2 negative breast cancer; Malignant-mesothelioma; Nasopharyngeal cancer; Non-small cell lung cancer; Oropharyngeal cancer; Pancreatic cancer; Penile cancer; Prostate cancer; Rectal cancer; Recurrent respiratory papillomatosis; Small cell lung cancer; Soft tissue sarcoma; Solid tumours; Squamous cell cancer; Triple negative breast cancer; Urogenital cancer; Vulvovaginal cancer

14 May 2026 National Cancer Institute (USA) completes a phase I/II trial for Cancer (Combination therapy, Metastatic disease, Second-line therapy or greater, Late-stage disease, Recurrent) in USA (IV, Infusion) (NCT04287868)
31 Mar 2026 National Cancer Institute completes a phase-I/II trial in Solid tumours (Metastatic disease, Monotherapy, Combination therapy, Recurrent) in USA (SC) (NCT04432597)
21 Mar 2025 EMD Serono completes a phase III clinical trial in Non-small cell lung cancer in Australia, Belgium, Brazil, China, France, Germany, Italy, Japan, Russia, South Korea, Spain, Taiwan, Turkey, Ukraine, USA (NCT05061823)

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