Drug intelligence / Profile preview

GC101 TIL + pembrolizumab

Development stage
Phase 3
Lead developer
Essen Biotech
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Cell Therapies
Administration
Intravenous
01

Overview

GC101 TIL + pembrolizumab is an investigational combination immunotherapy regimen consisting of autologous tumor-infiltrating lymphocytes (TILs), specifically the GC101 TIL product, administered with pembrolizumab (a PD-1 checkpoint inhibitor monoclonal antibody, brand name Keytruda). TIL therapy leverages a patient's own immune T cells, harvested from tumor tissue, expanded ex vivo, and reinfused to recognize and attack cancer cells. The GC101 TIL product represents a cryopreserved and expanded TIL preparation derived from the patient's tumor. Pembrolizumab potentiates this approach by blocking programmed death-1 (PD-1) signaling on T cells, thereby enhancing anti-tumor immune responses and potentially overcoming tumor-induced immunosuppression. This combination is in clinical development for advanced melanoma, selected brain tumors, gastrointestinal cancers, and other solid tumors refractory to standard treatments. The approach is personalized cell therapy and checkpoint inhibition, aiming to improve response rates and survival compared to single modalities. Development is sponsored by Essen Biotech, with clinical studies conducted at several academic institutions.

Brand names
Keytruda
Other names
GC101 TILGC-101 TILGC 101 TILpembrolizumab
02

Targets

PDCD1 (Programmed cell death protein 1 receptor)

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