nolgileucel + sintilimab

Tyvyt + GC101 (sintilimab + nolgileucel) is an investigational combination immunotherapy regimen being developed by Innovent Biologics and Juncell Therapeutics for the treatment of advanced solid tumors, specifically unresectable or metastatic melanoma. The regimen combines sintilimab (Tyvyt), a fully human IgG4 monoclonal antibody that targets and blocks the programmed cell death protein 1 (PD-1) receptor, with nolgileucel (GC101), an autologous tumor-infiltrating lymphocyte (TIL) cell therapy. Nolgileucel is manufactured using Juncell's proprietary DeepTIL cell enrichment and expansion platform, which produces highly active TILs that do not require high-intensity lymphodepletion or high-dose interleukin-2 (IL-2) administration, thereby reducing treatment-related toxicities. By combining TIL therapy with PD-1 checkpoint inhibition, the regimen aims to overcome resistance to prior anti-PD-1 therapies by reactivating and sustaining the antitumor activity of the infused lymphocytes. In the pivotal Phase II MIZAR-003 trial, the combination demonstrated a significant progression-free survival benefit compared to chemotherapy in patients with advanced melanoma who had progressed on prior anti-PD-1 therapy.

Other names

GC101 + TyvytGC101 + sintilimabTyvyt + GC101Tyvyt + nogileucelTyvyt + nolgileucelnogileucel + Tyvytnogileucel + sintilimabnolgileucel + Tyvytnolgileucel + sintilimabsintilimab + GC101sintilimab + nogileucelsintilimab + nolgileucel