A PHASE3 study (NCT06320353) comparing RPH-075, an investigational biosimilar of pembrolizumab (Keytruda), with Keytruda® itself in patients with unresectable or metastatic skin melanoma, reached primary completion on 2024-08-07. The trial aims to establish the equivalence of efficacy, safety, and immunogenicity between the two drugs.
Background
Pembrolizumab (Keytruda) is a widely used immunotherapy for various cancers. This study focuses on RPH-075, an investigational biosimilar of pembrolizumab. The trial is designed to compare RPH-075 against the reference product, Keytruda®, in patients with unresectable or metastatic skin melanoma, for use as first or second line therapy.
Trial design
The study, identified as NCT06320353, is a PHASE3, double-blind, randomized trial that enrolled 266 participants. The trial investigates patients with unresectable or metastatic skin melanoma receiving first or second line monotherapy. The primary goal is to evaluate and compare the effectiveness, safety, and immunogenicity of RPH-075 and Keytruda® to establish their equivalence.
What this means
The primary completion of this PHASE3 trial marks a significant step in the development of RPH-075 as a potential biosimilar to Keytruda®. The study's design to establish equivalence in efficacy, safety, and immunogenicity is crucial for demonstrating that RPH-075 can offer a comparable therapeutic option for patients with unresectable or metastatic skin melanoma. Clinicians and patients will await the full results to understand the comparative profile of RPH-075 relative to the established treatment.
Source
This information was sourced from ClinicalTrials.gov, documenting the primary completion of trial NCT06320353 on 2024-08-07. The study details are available on clinicaltrials.gov.