Samsung Bioepis Announces Positive Preliminary Phase 1 Data for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)


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.



Source link

  • Related Posts

    Insurity Challenges AI Hype in Insurance Core Systems, Calls on Insurance Carriers to Demand Real Cost and Timeline Reductions from Core System Vendors

    Across the market, vendors are marketing AI-native platforms, agentic product configurators, and embedded assistants that sit inside existing policy, billing, and claims systems. In practice, most of these offerings sprinkle…

    ‘Ohio is back’: Both parties navigate competitive midterm races in a forgotten battleground

    CLEVELAND — Two hard facts hover over this year’s midterm races in Ohio. Subscribe to read this story ad-free Get unlimited access to ad-free articles and exclusive content. It’s been…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Insurity Challenges AI Hype in Insurance Core Systems, Calls on Insurance Carriers to Demand Real Cost and Timeline Reductions from Core System Vendors

    R-Type Dimensions III Switch 1 & 2 Physical Release Hit With Delay

    R-Type Dimensions III Switch 1 & 2 Physical Release Hit With Delay

    This Is the New French It-Bag to Know

    This Is the New French It-Bag to Know

    Toronto Maple Leafs win NHL draft lottery

    Toronto Maple Leafs win NHL draft lottery

    ‘Ohio is back’: Both parties navigate competitive midterm races in a forgotten battleground

    ‘Ohio is back’: Both parties navigate competitive midterm races in a forgotten battleground

    Nuro receives driverless testing permit ahead of Uber robotaxi service launch

    Nuro receives driverless testing permit ahead of Uber robotaxi service launch