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disitamab vedotin + Bacillus Calmette-Guérin

Development stage: Unknown
Lead developer: RemeGen
Modality: Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration: Intravenous, Intravesical

Overview

disitamab vedotin + Bacillus Calmette-Guérin is a combination therapy being investigated for the treatment of HER2-expressing, high-risk non-muscle invasive bladder cancer (HR-NMIBC). Disitamab vedotin (RC48) is an antibody-drug conjugate (ADC) comprising a humanized anti-HER2 monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable linker. It selectively delivers the cytotoxic payload to HER2-positive tumor cells, inducing cell cycle arrest and apoptosis. Bacillus Calmette-Guérin (BCG) is a live-attenuated strain of Mycobacterium bovis that acts as an intravesical immunotherapy, stimulating a local inflammatory and immune response to eradicate residual cancer cells. The combination aims to enhance antitumor activity by combining targeted cytotoxicity with robust immune activation. A Phase III trial led by Fudan University is currently evaluating this regimen in BCG-naive patients with very high-risk NMIBC.

Brand names: Aidixi
Other names: disitamab vedotin + BCGRC48 + Bacillus Calmette-GuérinAidixi + BCG

Targets

TUBB (Tubulin (alpha and beta subunits))ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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