Samsung Bioepis, Phase 3 Study of Proposed Pembrolizumab Biosimilar at SITC 2026

Samsung Bioepis has announced the results of a Phase 3 clinical study evaluating SB27, a proposed biosimilar to Keytruda (pembrolizumab), at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2026. The study, which included 555 participants randomized to receive either SB27 or reference pembrolizumab, demonstrated equivalent objective response rate (ORR) at Week 24, with 34.6% for SB27 and 37.9% for reference pembrolizumab.

The 90% confidence interval for the ORR ratio between SB27 and reference pembrolizumab fell entirely within the pre-defined equivalence margin of 0.712 to 1.405, demonstrating equivalence. Secondary efficacy endpoints, including progression-free survival (PFS), duration response (DOR), and overall survival (OS), were also highly comparable between the two groups.

The safety, pharmacokinetics (PK), and immunogenicity profiles of SB27 were also found to be comparable to those of Keytruda.

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