GB-4362 + enfortumab vedotin + pembrolizumab

GB-4362 + Padcev + Keytruda is an investigational combination regimen being evaluated for the treatment of advanced or metastatic urothelial carcinoma. The regimen combines Padcev (enfortumab vedotin), a Nectin-4-directed antibody-drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload, and Keytruda (pembrolizumab), a PD-1-blocking monoclonal antibody, with GB-4362, an investigational monoclonal antibody developed by Generate Biomedicines. GB-4362 acts as a payload neutralizer that selectively binds and neutralizes free, circulating MMAE released from enfortumab vedotin without binding to the intact ADC. This supportive care component is designed to mitigate off-target toxicities, particularly treatment-limiting peripheral neuropathy, thereby expanding the therapeutic window and allowing patients to remain on the highly effective Padcev + Keytruda standard-of-care regimen longer.