- Published 2026.11.07 06:02
Equivalence in objective response rate at week 24 confirmed in 555 patients with metastatic non-small cell lung cancer
Large-scale data submitted to US FDA for approval as rivals scale back trials
Samsung Bioepis unveiled phase 3 results for SB27, a biosimilar of Keytruda (pembrolizumab), the world's top-selling immuno-oncology drug, for the first time at the Society for Immunotherapy of Cancer (SITC) 2026 in the United States. The move is seen as a strategy to gain the upper hand in the race to capture a blockbuster market worth 44 trillion won (about $32 billion) in annual sales by leveraging large-scale clinical data.
On Nov. 6 (local time), Samsung Bioepis presented 24-week efficacy equivalence data from the global phase 3 trial of SB27 at SITC 2026 in Phoenix, Arizona. In 555 patients with metastatic non-squamous non-small cell lung cancer, the objective response rate (ORR) at week 24 was 34.6% for SB27 and 37.9% for Keytruda, meeting the predefined equivalence criteria.
Secondary efficacy endpoints including progression-free survival (PFS), duration of response (DOR), and overall survival (OS) also showed similar results between the two arms. Safety and pharmacokinetic (PK) measures such as grade 3 or higher treatment-emergent adverse events (TEAEs) and immune-related adverse reactions showed no significant differences compared with the original drug.
Shin Dong-hoon, executive vice president and head of clinical development at Samsung Bioepis, said at the conference, "Oncology is an important focus area for Samsung Bioepis, and the development of SB27 demonstrates the company's continued commitment to advancing high-quality biosimilar medicines," adding, "Our goal is to establish robust clinical evidence to potentially provide biosimilar treatment options to oncology patients worldwide."
Keytruda, developed by US pharmaceutical company MSD, is an immune checkpoint inhibitor used for various cancers including melanoma and non-small cell lung cancer. It is a blockbuster drug with global sales of $31.7 billion (about 44 trillion won) last year. With key substance patents set to expire in the United States in 2028 and in Europe in 2031, global pharmaceutical companies are competing fiercely to develop biosimilars.
Amid recent regulatory easing by the US Food and Drug Administration (FDA), some competitors are revising development strategies, including scaling back phase 3 trials. Germany's Formycon filed for FDA approval in October 2026 with only phase 1 data and no comparative efficacy phase 3 trial, while Korea's Celltrion reduced its phase 3 patient count from 606 to 220. In contrast, Samsung Bioepis completed a large-scale phase 3 trial in 555 patients across 14 countries to secure efficacy data.
Based on this large-scale clinical data, Samsung Bioepis applied for approval of SB27 to Korea's Ministry of Food and Drug Safety in August 2026 and to the US FDA in October 2026. It sought approval for all 18 indications held by the original drug, including melanoma and non-small cell lung cancer, and plans to compile final phase 3 data by the end of this year.
(Dollar figures are approximate, converted automatically at 1,000 won = $0.738, the rate on Nov. 8, 2026.)
※ This article is an AI translation of the Korean original published by Korea Credit News; it was checked by automated quality guards and published by the English edition desk.
