Initiated in January 2024, Phase 1 study is being conducted in four countries, and is expected to be completed by November 2026.2 The study assessed pharmacokinetics, efficacy, safety, and immunogenicity of SB27, EU-sourced Keytruda, and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every 3 weeks, maximum 18 cycles over about 51 weeks, and blood samples were collected. The preliminary pharmacokinetic evaluation indicates that the drug exposure, measured by the Area Under the Curve (AUC), has met the predefined equivalence criteria.
