CDSCO Panel Approves GSK Protocol Amendment proposal for Belrestotug and Dostarlimab study

As an optimized, high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses that induces cytokine release and antibody-dependent cellular cytotoxicity-(ADCC).

Dostarlimab is an anti-PD-1 monoclonal antibody used in the treatment of mismatch repair-deficient endometrial cancers and solid tumors with no alternative treatment options.

Dostarlimab is an IgG4 humanized monoclonal antibody targeted against the human programmed death receptor-1 (PD-1).6 PD-1 receptors are found on T-cells and, when activated, serve to inhibit immune responses - some cancers leverage this system by overexpressing PD-1 ligands, thereby effectively inhibiting the anti-tumor immune response that would typically attempt to destroy the cancerous cells. Agents acting on the PD-1 pathway, such as nivolumab and pembrolizumab, facilitate endogenous immune-mediated anti-tumor activity and may therefore be used to treat a wide variety of cancers, including those of the skin, lung, kidneys, and liver.

Previously, the Medical Dialogue Team had reported that the committee had granted permission to conduct the phase 3 clinical trial of the anti-cancer drugs GSK4428859A (Belrestotug) and GSK4057190 (Dostarlimab).

At the recent SEC meeting for Oncology held on 10th December 2024, the expert panel reviewed the protocol amendment 2 dated 13 September 2024 protocol no. 213823.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

Also Read:MSD Pharmaceutical Gets CDSCO Panel Nod To study MK-1084