Samsung Bioepis has announced positive preliminary results from its Phase 1 clinical trial evaluating SB27, a proposed biosimilar to Keytruda (pembrolizumab). The study successfully met its primary Pharmacokinetic (PK) endpoints, demonstrating bioequivalence between SB27 and the reference product.

The randomised, double-blind, three-arm, parallel-group multicentre study was initiated in January 2024 and is being conducted across four countries. The trial evaluated the pharmacokinetics, efficacy, safety and immunogenicity of SB27 compared with both EU-sourced and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection and adjuvant platinum-based chemotherapy.

A total of 163 participants were randomised to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every three weeks for up to 18 treatment cycles over approximately 51 weeks. Blood samples collected during the study showed that drug exposure levels, measured through Area Under the Curve (AUC), met predefined equivalence criteria, confirming pharmacokinetic similarity between the biosimilar candidate and the reference therapy.

Commenting on the development, Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis, said the positive topline results reinforce the company’s scientific expertise and leadership in biosimilar development. He added that the company remains on track to complete both Phase 1 and Phase 3 studies within the year while continuing to expand patient access through its growing biosimilar portfolio.

Samsung Bioepis also stated that its ongoing Phase 3 clinical study, initiated in March 2024, is expected to conclude in 2026. The study aims to compare the efficacy, safety, pharmacokinetics and immunogenicity of SB27 against Keytruda in patients with metastatic non-squamous NSCLC.

Pembrolizumab is a humanised monoclonal antibody that functions as an immune checkpoint inhibitor by targeting the programmed cell death protein 1 (PD-1) receptor on T cells. It is widely used in the treatment of several cancers, including melanoma, NSCLC and head and neck squamous cell carcinoma.

Established in 2012, Samsung Bioepis develops biosimilar and biologic therapies across therapeutic areas including oncology, immunology, nephrology, hematology and endocrinology. The company continues to strengthen its global biosimilar pipeline with a focus on expanding access to advanced biologic treatments.