AstraZeneca Pharma India gets CDSCO Panel Nod to study anti-cancer drug Datopotamab deruxtecan/Rilvegostomig

New Delhi: The drug major AstraZeneca Pharma India has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 3 clinical study of the anti-cancer drug Datopotamab deruxtecan (DS-1062a) 100mg/ vial Rilvegostomig (AZD2936) 750 mg/vial (50 mg/ml).

This came after AstraZeneca Pharma India presented phase 3 clinical study protocol no. D7632C00001 version 1.0, dated 30 October 2023. This is a Phase III, randomized, open-label, global study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy versus Pembrolizumab monotherapy for the first-line treatment of participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

The purpose of this study is to evaluate the efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Non-small cell lung cancer (NSCLC) is a disease in which malignant (cancer) cells form in the tissues of the lung.

Datopotamab deruxtecan (Dato-DXd) is an antibody-drug conjugate consisting of a humanized antitrophoblast cell-surface antigen 2 (TROP2) monoclonal antibody linked to a potent, exatecan-derived topoisomerase I inhibitor payload via a plasma-stable, selectively cleavable linker.

Rilvegostomig simultaneously targets, binds to and inhibits PD-1 and TIGIT and their downstream signaling pathways. Inhibition of PD-1-mediated signaling may restore immune function through the activation of T-cells and T-cell-mediated immune responses.

At the recent SEC meeting for Oncology held on June 18, 2024, the expert panel reviewed phase 3 clinical study protocol no. D7632C00001 version 1.0 dated 30 October 2023.

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

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