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

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major GSK's protocol amendment proposal for anticancer drug GSK4428859A (Belrestotug), GSK 4057190 (Dostarlimab) study.

This came after the firm presented protocol amendment 2 dated 13 September 2024 protocol no.213823.

Belrestotug is an Fc-active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor that contributes to the suppression of the innate immune system.

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.

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