GSK Pharma India Gets CDSCO Panel Nod for phase 3 CT of Belrestotug and Dostarlimab

New Delhi: The drug major GSK Pharma India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the phase 3 clinical trial of the anti-cancer drug GSK4428859A (Belrestotug) and GSK4057190 (Dostarlimab).

This came after GSK Pharma India presented phase 3 clinical study protocol no. 213823 dated 09 January 2024.

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 which contributes to the suppression of 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 tumours 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.3 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.

At the recent SEC meeting for oncology held on July 9, 2024, the expert panel reviewed phase 3 clinical study protocol no. 213823 dated 09 January 2024, presented by GSK Pharma India.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

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