Samsung Bioepis headquarters in Songdo, Incheon
Samsung Bioepis Co., Ltd. Nov. 6 announced findings from the Phase 3 clinical study evaluating SB27, a proposed biosimilar to Keytruda (pembrolizumab), at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2026 held in Phoenix, Arizona from Nov. 4 to 8, 2026.
“Oncology remains an important area of focus for Samsung Bioepis, and the development of SB27 reflects our continued commitment to advancing high-quality biosimilar medicines,” said Donghoon Shin, Executive Vice President and Clinical Sciences Division Leader at Samsung Bioepis. “We aim to establish a robust clinical evidence base to support the development of a potential biosimilar treatment option for oncology patients worldwide.”
Pembrolizumab is a humanized monoclonal antibody that acts as an immune checkpoint inhibitor by targeting and blocking the programmed cell death protein 1 (PD-1) receptor on T cells. It is used to treat various types of cancer, including melanoma, non-small cell lung cancer (NSCLC), and head and neck squamous cell cancer (HNSCC).
The randomized, double-blind, parallel group, multicenter Phase 3 clinical trial demonstrated equivalent objective response rate (ORR) at Week 24. The study assessed efficacy, safety, pharmacokinetics (PK), and immunogenicity of SB27 compared to reference pembrolizumab in patients with metastatic non-squamous NSCLC, administered concurrently with first-line chemotherapy.
In the study, 555 participants were randomized (1:1 ratio) to receive either SB27 (n=283) or reference pembrolizumab (n=272) at 200 mg intravenously every 3 weeks concurrently with pemetrexed every three weeks, and carboplatin every three weeks for the first 4 cycles. The primary endpoint of ORR at Week 24 was 34.6% for SB27 and 37.9% for reference pembrolizumab. The 90% confidence interval (CI) for the ORR ratio between SB27 and reference pembrolizumab was 0.737 to 1.071, which fell entirely within the pre-defined equivalence margin of 0.712 to 1.405, demonstrating equivalence. Secondary efficacy endpoints were also highly comparable between the two groups, including progression-free survival (PFS), duration response (DOR), and overall survival (OS). The safety, PK and immunogenicity profiles of SB27 were also comparable to those of Keytruda.
