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As of January 2024, Keytruda has been approved for 6 indications in NSCLC across the metastatic and earlier stages of the disease.
Samsung Bioepis Co Ltd has initiated a phase 1 clinical trial for SB27, a proposed biosimilar for pembrolizumab (Keytruda; Merck).1
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NCSLC accounts for approximately 80% to 85% of lung cancer cases, according to the American Cancer Society. Lung cancer is the second most common cancer in the United States excluding skin cancer, with an estimated 234,580 new cases and 125,070 deaths in 2024.2
Name: A Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Pembrolizumab (SB27, EU Sourced Keytruda, and US Sourced Keytruda) in Subjects With Stage II-IIIA NSCLC Following Complete Resection and Adjuvant Platinum-based Chemotherapy
ClinicalTrial.gov ID: NCT06268613
Sponsor: Samsung Bioepis
Estimated Completion Date: December 2025
According to the organization, lung cancer primarily occurs in older individuals, with most patients being diagnosed at age 65 or older and a small number being diagnosed at 45 or younger. Additionally, lung cancer accounts for approximately 1 in 5 of all cancer deaths—more than colon, breast, and prostate cancers combined, according to the American Cancer Society.2
The phase 1 clinical trial (NCT06268613) of the proposed biosimilar will be a randomized, double-blinded, multicenter study intended to determine the pharmacokinetics, efficacy, safety, and immunogenicity of the biosimilar against the reference drug, both the European Union-sourced and United States-sourced drug. The patient population will include individuals with stage 2 or 3A non–small cell lung cancer (NSCLC) after complete resection and adjuvant platinum-based chemotherapy.1
Individuals included in the study will be aged 18 years and older, have complete removal of all cancer via surgery, and have received 3 or 4 cycles of platinum-based chemotherapy. Patients will be excluded if they had anti-cancer therapy prior to surgery and if they have or had an autoimmune disease within the past 5 years, according to the clinical trial information. All pembrolizumab formulations will be given intravenously at a fixed dose of 200 mg every 3 weeks with a maximum of 18 cycles over 51 weeks.3
Primary outcomes will be the area under the concentration-time curve over the dosing interval at cycle 1 and again at cycle 6. Secondary endpoints will include disease-free survival and overall survival, according to the clinical trial information. The estimated completion date is December 2025, with the primary completion date being July 2025.3
As of January 2024, Keytruda has been approved for 6 indications of NSCLC across the metastatic and earlier stages of the disease.4 The drug has been approved for melanoma, head and neck squamous cell cancers, classic Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial cancer, gastric cancer, esophageal cancer, cervical cancer, biliary tract cancer, renal cell carcinoma, and more, for various lines of therapy across indications, as well as combination and monotherapy.4
According to the press release, Samsung Bioepis currently has 7 biosimilars approved and available worldwide, which includes etanercept, infliximab, adalimumab, and trastuzumab. There are also 3 other biosimilars currently in the pipeline, including SB15 (aflibercept), SB16 (denosumab), and SB17 (ustekinumab), which had all completed phase 3 clinical trials, according to the press release.1
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