On the 9th, Samsung Bioepis announced that it presented the results of the global Phase 3 clinical trial for “SB27” at the 2026 Annual Meeting of the Society for Immunotherapy of Cancer (SITC), held in Phoenix, Arizona, from the 4th to the 8th.
SITC is a leading global conference where experts from the medical and scientific communities around the world gather annually to discuss the latest research and treatment technologies in the field of immuno-oncology. Samsung Bioepis presented efficacy and safety data from a study involving patients with metastatic non-squamous non-small cell lung cancer.
This clinical trial was conducted starting in 2024 across 14 countries worldwide, involving 555 patients. It was designed as a randomized, double-blind study comparing the outcomes of patients treated with SB27 or the originator drug in combination with standard chemotherapy.
The objective response rate (ORR) at week 24, the primary endpoint, met the predefined regulatory equivalence criteria. Key secondary efficacy endpoints—including progression-free survival (PFS), duration of response (DOR), and overall survival (OS)—also showed results similar to those of the originator drug.
Safety was also confirmed to be at a level similar to that of the original drug. The incidence rates of adverse events and serious adverse events following treatment were comparable, and no neutralizing antibodies (NAbs) capable of neutralizing the drug’s efficacy were observed.
The originator drug for SB27, Keytruda, is an immunotherapy developed by the U.S. pharmaceutical company MSD. It binds to the immune checkpoint receptor PD-1 to inhibit cancer cells’ immune evasion and help immune cells attack cancer cells. Its global sales last year are reported to have been approximately $31.7 billion (about 46 trillion won).
Samsung Bioepis submitted an application for marketing authorization for SB27 to the Ministry of Food and Drug Safety last August—the first such application in Korea. Last month, the company also filed for marketing authorization in the United States. The company plans to launch the product in the global market after completing regulatory approval processes in each country.
Shin Dong-hoon, Executive Vice President and Head of Clinical Medicine at Samsung Bioepis, stated, “Through this presentation at SITC, we successfully demonstrated the primary endpoint in a large-scale global Phase 3 clinical trial, proving the clinical equivalence and consistent safety of SB27 compared to the originator drug.” He added, “We will continue to focus our development capabilities on increasing patient access to high-quality anti-cancer biologics and expanding the benefits of treatment.”
