CDSCO Panel Approves AstraZeneca's Protocol Amendment Proposal For Anti-cancer Drug Volrustomig study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved AstraZeneca's protocol amendment proposal for study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical).

This came after the firm presented protocol amendment version 4.0 dated 03 September 2024 protocol no. D7984C00002. This is a phase III, randomized, double-blind, placebo-controlled, multi-centre, global study of volrustomig in women with high-risk locally advanced cervical cancer who have not progressed following platinum-based, concurrent chemoradiation therapy (eVOLVE-Cervical).

Volrustomig is another type of immunotherapy. It works by targeting and blocking the proteins PD-L1 and CTLA-4 on the surface of T cells. Blocking these 2 proteins triggers the immune system to find and kill cancer cells.

Volrustomig is an engineered fragment crystallizable (Fc) domain bispecific human immunoglobulin G1 (IgG1) monoclonal antibody directed against the human negative immunoregulatory checkpoint receptor programmed cell death protein 1 (PD-1; PDCD1; CD279) and cytotoxic T-lymphocyte-associated antigen 4 (CTLA4; CTLA-4), with potential immune checkpoint inhibitory and antineoplastic activities.

Upon administration, volrustomig targets and binds to both PD-1 and CTLA4 expressed on tumor-infiltrating T lymphocytes (TILs), and inhibits the PD-1- and CTLA4-mediated downregulation of T-cell activation and proliferation. In addition, volrustomig is internalized and is able to degrade PD-1. This restores immune function and activates a sustained cytotoxic T-lymphocyte (CTL)-mediated immune response against tumor cells. Both PD-1 and CTLA4 are selectively expressed on TILs in the tumor microenvironment (TME) and negatively regulate the activation and effector functions of T cells. They play key roles in the downregulation of the immune system and tumor evasion from host immunity. Dual checkpoint blockade of PD1 and CTLA4 with volrustomig may enhance T-cell activation and proliferation more than the blockade of either immune checkpoint receptor alone. It may also decrease toxicity by avoiding binding to CTLA-4-expressing T cells that are devoid of PD-1. The engineered Fc domain may reduce Fc effector function.

At the recent SEC meeting for Oncology, the expert panel reviewed the protocol amendment version 4.0 dated 03 September 2024 protocol no. D7984C00002.

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

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