Samsung Bioepis Initiates Phase 3 Clinical Trial for Proposed Pembrolizumab Biosimilar

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The trial will compared the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and pembrolizumab for metastatic non-squamous non-small cell lung cancer.

Samsung Bioepis announced the initiation of a phase 3 clinical trial for SB27, a proposed biosimilar referencing pembrolizumab (Keytruda; Merck), according to a press release from the company.1

“We are thrilled to announce the initiation of [a] phase 3 clinical trial for SB27, after our successful phase 1 clinical trial initiation in February 2024,” Ilsun Hong, vice president of Product Evaluation Team Leader of Samsung Bioepis, said in the press release. “Based on our extensive clinical trial experience accumulated over the years, we will work closely with study investigators to ensure successful completion of the clinical trials for SB27.”1

3d rendered illustration of lung cancer 3D illustration | Image Credit: appledesign - stock.adobe.com

Image Credit: appledesign - stock.adobe.com

The phase 3 clinical trial (NCT06348199) will be a randomized, double-blind, multicenter study intended to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and pembrolizumab for patients with metastatic non-squamous non-small cell lung cancer (NSCLC). Investigators will randomize treatment 1:1 for SB27 and pembrolizumab 200 mg intravenously every 3 weeks concurrently with chemotherapy (pemetrexed 500 mg/m2 with vitamin supplementation as an intravenous infusion over 10 minutes every 3 weeks, and carboplatin over 15 to 60 minutes every 3 weeks for the first 4 cycles), according to the press release.1

According to the clinical trial information, individuals aged 18 years and older with stage IV non-squamous NSCLC who have not received prior systemic anti-cancer therapy for metastatic NSCLC will be included. Investigators will be measuring the objective response rate at week 24, which is defined as the proportion of individuals achieving a complete response or partial response, according to the clinical trial information. The estimated completion date of the study is March 2027, with the primary completion in September 2025.2

In February 2024, the company announced a phase 1 clinical trial (NCT06268613), which will be a randomized, double blinded, multicenter study to determine the pharmacokinetic, efficacy, safety, and immunogenicity with the reference product. The reference product will include both the European Union-sourced and United States-sourced drugs, according to an article in Pharmacy Times.3

In the phase 1 clinical trial, patients included have stage 2 or 3A NSCLC after complete resection and adjuvant platinum-based chemotherapy. The primary outcome will be the area under the concentration-time curve over the dosing interval at cycle 1 and cycle 6, according to the article in Pharmacy Times. Secondary endpoints include disease free survival, and progression free survival.3

About The Trial

Trial Name: A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer

ClinicalTrial.gov ID: NCT06348199

Sponsor: Samsung Bioepis Co Ltd

Completion Date (Estimated): March 2027

As of April 2024, Samsung Bioepis has 8 biosimilars approved and 7 available worldwide, including for etanercept, infliximab, adalimumab, trastuzumab, bevacizumab, ranibizumab, eculizumab, and aflibercept. There are also 3 biosimilar candidates in pipeline, including for denosumab, ustekinumab and pembrolizumab, according to the press release.1

As of January 2024, pembrolizumab has been approved for 6 indications of NSCLC across the metastatic and early stages of disease, as well as for a variety of lines in melanoma, head and neck squamous cell cancers, classic Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, and more.3

References
  1. Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab). News release. Samsung Bioepis. April 5, 2024. Accessed April 5, 2024. https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=385%C2%A4tPage=1
  2. Gallagher A. Samsung Bioepis Initiates Phase 1 Trial for Proposed Keytruda Biosimilar. Pharmacy Times. February 26, 2024. Accessed April 5, 2024. https://www.pharmacytimes.com/view/samsung-bioepis-initiates-phase-1-trial-for-proposed-keytruda-biosimilar
  3. A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer. ClinicalTrials.gov identifier: NCT06348199. Updated April 4, 2024. Accessed April 5, 2024. https://clinicaltrials.gov/study/NCT06348199?term=NCT06348199&rank=1
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