Biosimilar to Keytruda Shows Promise
Samsung Bioepis Co., Ltd. has announced positive preliminary results from its Phase 1 study of SB27, a proposed biosimilar to Keytruda (pembrolizumab). The study, conducted across multiple countries, demonstrated pharmacokinetic equivalence between SB27 and Keytruda in patients with non-small cell lung cancer (NSCLC).
Initiated in January 2024, the Phase 1 study included 163 participants who were treated with either SB27, EU-sourced Keytruda, or US-sourced Keytruda. Participants received treatment every three weeks for up to 18 cycles. The study focused on pharmacokinetics, efficacy, safety, and immunogenicity, and met its primary endpoint of pharmacokinetic bioequivalence.
The trial was conducted in four countries and is expected to be completed by November 2026. Blood samples were collected to assess drug exposure, and the preliminary pharmacokinetic evaluation indicates that the Area Under the Curve (AUC) met the predefined equivalence criteria.
Donghoon Shin, Executive Vice President and Head of Clinical Sciences Division at Samsung Bioepis, highlighted the importance of these findings, stating, "We are excited to announce preliminary results from the Phase 1 study for SB27, our pembrolizumab biosimilar candidate. These topline positive results reinforce our scientific expertise and leadership in biosimilar development."
Next Steps for SB27 Development
The Phase 3 study of SB27, initiated in March 2024, aims to further evaluate the biosimilar's efficacy and safety compared to Keytruda in patients with metastatic non-squamous NSCLC. Completion of both Phase 1 and Phase 3 studies is anticipated by the end of 2026.
Pembrolizumab, marketed as Keytruda, is widely used to treat various cancers, including melanoma and head and neck squamous cell cancer. SB27, as a biosimilar, aims to offer a more accessible alternative to patients.
SB27 targets the programmed cell death protein 1 (PD-1) receptor on T cells, acting as an immune checkpoint inhibitor. This mechanism is crucial in treating various cancers by helping the immune system attack cancer cells more effectively.
Samsung Bioepis, established in 2012, is committed to making healthcare accessible through innovative biopharmaceutical products. As a subsidiary of Samsung Epis Holdings, the company continues to advance a broad pipeline of biologic candidates.
Details about the ongoing studies and further updates on SB27's development can be accessed through ClinicalTrials.gov, with the Phase 1 study registered under NCT06268613.
