Samsung Bioepis said on Monday that it presented Phase 1 clinical trial results for SB27, a biosimilar candidate for Keytruda (ingredient: pembrolizumab), at the European Society for Medical Oncology (ESMO) Congress, one of Europe's largest oncology conferences, held in Madrid, Spain, since Oct. 23 local time.
Samsung Bioepis is a wholly owned subsidiary of Samsung Epis Holdings. It primarily researches and develops biosimilars and new drugs. The company plans to announce its third-quarter results on Oct. 28.
Keytruda, developed by U.S. pharmaceutical giant Merck & Co. (MSD), is the world's top-selling immuno-oncology drug. Its global sales reached approximately 46 trillion won last year.
Since 2024, Samsung Bioepis has conducted a Phase 1 clinical trial of SB27 involving 163 patients with non-small cell lung cancer in four countries, including South Korea.
An analysis of the primary endpoint of the Phase 1 trial — the area under the concentration-time curve (AUC) at a prespecified time after administration — demonstrated pharmacokinetic equivalence between SB27 and the original drug. The company also confirmed similarities in efficacy and safety between SB27 and the reference product.
"Phase 1 results for SB27 confirmed pharmacokinetic equivalence to the original drug, along with similarities in efficacy and safety," said Shin Dong-hoon, vice president and head of clinical development at Samsung Bioepis. "We will continue developing cancer biosimilars that patients and healthcare professionals can trust, based on rigorous analytical and clinical standards."
in THEBIO
