Samsung Bioepis Presents Phase 3 Study Of Proposed Pembrolizumab Biosimilar At SITC 2026

Poster presentation highlights comparative study of SB27 and reference pembrolizumab in patients with metastatic non-squamous non-small cell lung cancer (NSCLC)

Samsung Bioepis Co., Ltd. today announced findings from the Phase 3 clinical study evaluating SB27, a proposed biosimilar to Keytruda¹ (pembrolizumab), at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2026 held in Phoenix, Arizona from November 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).²

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.³

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.

Presentation details

• Abstract number: 539
• Presentation date: Friday, November 6, 2026
• Presentation type: Poster
• Title: A Randomized, Double-blind, Phase III Trial to Compare SB27 (A Proposed Biosimilar to Pembrolizumab) to Reference Pembrolizumab in Participants with Metastatic Non-squamous Non-small Cell Lung Cancer

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings (KRX: 0126Z0), Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology, and neurology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

¹ Keytruda is a trademark of Merck Sharp & Dohme LLC.

² European Medicines Agency (EMA). Keytruda Summary of Product Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf Last accessed November 2026.

³ ClinicalTrials.gov (NCT06348199). A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer. Available at: https://clinicaltrials.gov/study/NCT06348199 (Accessed November 2026)