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.
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