Samsung Epis Holding disclosed on the 29th that the primary efficacy analysis from the global Phase 3 clinical trial of 'SB27 (pembrolizumab biosimilar),' currently under development by its subsidiary Samsung Bioepis, has met the equivalence criteria with the original drug.

This global Phase 3 trial was conducted to compare the efficacy, safety, pharmacokinetics, and immunogenicity of SB27 with those of the original drug, Keytruda, in patients with metastatic non-squamous non-small cell lung cancer. A total of 555 patients participated in the trial across 93 institutions in 14 countries.

The key clinical results announced by the company are as follows:

• Efficacy: Analysis of the primary endpoint, objective response rate (ORR) at week 24, showed that the 90% confidence interval for the ORR ratio between SB27 and Keytruda was 0.737–1.071. This falls within the pre-specified equivalence criteria range (0.712–1.405), fully meeting the predefined equivalence standard for the primary efficacy endpoint.
• Safety: The incidence rate of treatment-emergent adverse events (TEAEs) was similar between the two groups, at 92.1% for SB27 and 94.9% for Keytruda. The proportion of patients who experienced one or more serious treatment-emergent adverse events (Serious TEAEs) was also comparable, at 38.9% for SB27 and 37.1% for Keytruda. The severity distribution of adverse events and other safety indicators showed similar levels between the two drugs.

The company noted that these results are from an interim analysis of the Phase 3 trial. It plans to complete additional data collection in accordance with the clinical trial protocol and subsequently conduct a final analysis. Additionally, the company explained that the fact-checking date for this disclosure is June 26, 2026, when the Clinical Study Report (CSR) is expected to be obtained.

Finally, the company cautioned investors: 'Clinical trials for biologics may yield results that fall short of expectations during the final product approval process, which could lead to changes in or discontinuation of commercialization plans, so investors should exercise caution.'