Sandoz’s Pembrolizumab Biosimilar Study: A Potential Game Changer in Melanoma Treatment

Sandoz Group Ltd ((SDZXF)) announced an update on their ongoing clinical study.

Sandoz Group Ltd is conducting a clinical study titled ‘A Randomized, Double-blind, Parallel-group Study to Compare Pharmacokinetics of GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU Authorized Keytruda® in Participants With Stage II and III Melanoma Requiring Adjuvant Treatment With Pembrolizumab.’ The study aims to evaluate the pharmacokinetic similarity, efficacy, safety, and immunogenicity of GME751 compared to Keytruda® in patients with resected advanced melanoma.

The study tests the experimental drug GME751, a proposed biosimilar to pembrolizumab, against two active comparators: Keytruda-EU and Keytruda-US. Each drug is administered via intravenous infusion every six weeks over a 24-week period.

This interventional study is randomized and employs a parallel assignment model with double masking for participants and investigators. Its primary purpose is treatment-focused, aiming to provide an alternative biosimilar option for melanoma patients.

The study began on October 11, 2023, with an estimated primary completion date in 2025. The last update was submitted on July 3, 2025, indicating ongoing recruitment and progress.

The potential introduction of a successful pembrolizumab biosimilar by Sandoz could impact the market by providing a cost-effective alternative to Keytruda, potentially affecting the stock performance of both Sandoz and its competitors. Investors should monitor the study’s progress for future developments.

The study is currently ongoing, with further details available on the ClinicalTrials portal.