AstraZeneca Gets CDSCO Panel Nod To study Anti-Cancer Drug Rilvegostomig
New Delhi: Pharmaceutical major AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Standard Control Organization (CDSCO) to conduct a phase 3 clinical study of the anticancer drug Rilvegostomig (AZD2936) concentrate for solution for infusion, 50 mg/mL (750 mg/vial).
This came after the drug maker AstraZeneca presented phase 3 clinical study protocol no. D702FC00001, Version 2.0 dated 30 Jul 2024, and Local CSP -Addendum IND -1, Version 1.0 dated 26 Jul 2024. This is a phase III, randomized, double-blind, multicenter global study of rilvegostomig or pembrolizumab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer whose tumors express PD-L1 (ARTEMIDE-Lung03).
Rilvegostomig (AZD2936) is a monovalent, bispecific, humanized IgG1 antibody that specifically binds to human TIGIT and PD-L1 with high affinity and enhances T cell activity within preclinical models. Rilvegostomig is a new type of immunotherapy. It works in a similar way to pembrolizumab. Rilvegostomig also blocks another protein called TIGIT. By blocking TIGIT, rilvegostomig could help the immune system recognize cancer cells and stop the cancer from growing.
At the recent SEC meeting for Oncology held on 10th December 2024, the expert panel reviewed the phase 3 clinical study protocol no. D702FC00001, Version 2.0 dated 30 Jul 2024, and Local CSP -Addendum IND -1, Version 1.0 dated 26 Jul 2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial with the following conditions:
1. PK (pharmacokinetic) data in Indian patients shall be generated and submitted to CDSCO.
2. ICMR permission shall be obtained for the export of biological samples for genetic testing.
