In light of the earlier recommendation of SEC (Oncology) dated March 20, 2025, the firm presented the protocol to conduct a Phase I/III clinical trial titled “A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Two-Arm Comparative Phase I/III Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of R-TPR-067 (RLS-Nivolumab) and Opdivo®/Opdyta® administered by intravenous route in Patients previously treated for Locally Advanced or Metastatic Non-Small Cell Lung Cancer” vide Protocol No.: RLS/ONC/2024/05 Version 2.0 dated April 9, 2025.
After detailed deliberation, the committee recommended for grant of permission to conduct the Phase I/III clinical trial as per the protocol presented by the firm.
Nivolumab, marketed globally as Opdivo® and Opdyta®, is an immune checkpoint inhibitor targeting the programmed death-1 (PD-1) receptor. By blocking the PD-1 pathway, it enhances the body’s immune system to detect and attack cancer cells more effectively. It is approved internationally for several cancers, including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, and head and neck squamous cell carcinoma, among others.
The trial aims to establish comparability in efficacy, safety, pharmacokinetics, and immunogenicity between Reliance Life Sciences’ biosimilar Nivolumab (RLS-Nivolumab) and the reference innovator product Opdivo®/Opdyta®. The study will involve patients who have been previously treated for locally advanced or metastatic NSCLC, a cancer type representing one of the leading causes of cancer-related deaths worldwide.
Reliance Life Sciences Pvt. Ltd., part of the Reliance Group, is an Indian biotechnology company focused on research, development, and manufacturing of complex biologics, biosimilars, and novel therapeutic entities. The company has been actively working to develop affordable biotherapeutics in oncology, immunology, and other life-threatening diseases, aiming to make advanced therapies accessible to patients globally.
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