CDSCO Panel approval granted for Clinical Trial of this Anti Cancer Drug

This clinical trial signifies a promising step forward in exploring new treatment options for patients with specific types of NSCLC.

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Clinical Trial Research
Clinical Trial

Last Updated on July 12, 2024 by The Health Master

Clinical Trial

AstraZeneca Pharma India received approval from the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee (SEC) to conduct a Phase 3 clinical trial for a novel lung cancer treatment regimen.

This clinical trial marks a significant step forward in the fight against this aggressive disease, particularly for patients with a specific genetic profile.

What is the Clinical Trial About?

Targeted Patient Population:

The clinical trial will focus on individuals with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC).

Additionally, patients must have high levels of PD-L1 expression (tumor proportion score ≥ 50%) and lack targetable genetic alterations.

Treatment Arms:

The study design is randomized, open-label, and global.

Participants will be assigned to one of three treatment arms:

Datopotamab Deruxtecan (Dato-DXd) + Rilvegostomig Combination:

This arm investigates the efficacy and safety of combining Dato-DXd, a targeted antibody-drug conjugate, with Rilvegostomig, a novel dual immune checkpoint inhibitor.

Rilvegostomig Monotherapy:

This arm evaluates the effectiveness of Rilvegostomig alone in this patient population.

Pembrolizumab Monotherapy:

This arm serves as the current standard of care comparison, using the established immunotherapy drug Pembrolizumab.

What are the Potential Benefits?

The primary objective of the clinical trial is to assess the efficacy and safety of the Dato-DXd and Rilvegostomig combination compared to Pembrolizumab monotherapy as a first-line treatment for this specific NSCLC population.

Understanding the Drugs:

Datopotamab Deruxtecan (Dato-DXd):

This drug is an antibody-drug conjugate (ADC).

It works by delivering a potent cell-killing agent directly to cancer cells.

The ADC consists of:

Humanized Anti-TROP2 Monoclonal Antibody:

This antibody specifically targets TROP-2, a protein overexpressed on many cancer cells.

Exatecan-Derived Topoisomerase I Inhibitor Payload:

This is the cell-killing component that disrupts cancer cell growth.

Rilvegostomig:

This drug is a next-generation immunotherapy that simultaneously targets two immune checkpoint proteins: PD-1 and TIGIT.

By blocking these checkpoints, Rilvegostomig aims to unleash a stronger anti-tumor immune response.

Clinical Trial Approval Process:

The SEC meeting for Oncology, held on June 18, 2024, reviewed AstraZeneca Pharma India’s Phase 3 clinical trial proposal (protocol no. D7632C00001 version 1.0 dated October 30, 2023).

After a thorough evaluation, the committee granted permission to conduct the clinical trial as presented.

This clinical trial signifies a promising step forward in exploring new treatment options for patients with specific types of NSCLC.

The combination of Dato-DXd and Rilvegostomig has the potential to offer a more effective and potentially less toxic therapy compared to current standards.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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