SB27 (pembrolizumab biosimilar) / Samsung - LARVOL DELTA

Samsung Bioepis said on the 10th it applied to the Ministery of Food and Drug Safety for marketing approval of its Keytruda biosimilar candidate SB27 (ingredient name pembrolizumab). (Chosun Biz) - "This application includes indications for a total of 16 diseases, including melanoma, Non-small cell lung cancer (NSCLC), and head and neck cancer."

Korea filing • Head and Neck Cancer • Melanoma • Non Small Cell Lung Cancer

The phase 3 trial demonstrated equivalent objective response rates (ORR) at week 24 in 555 patients with metastatic non-squamous NSCLC. (Korea Biomedical Review) - "'We are on track to complete both phase 1 and phase 3 studies within this year.'....The 90 percent confidence interval for the ORR ratio between SB27 and Keytruda was 0.737 to 1.071, within the pre-defined equivalence margin of 0.712 to 1.405. Safety, pharmacokinetic, and immunogenicity profiles were comparable, Samsung Bioepis said."

P3 data • Trial completion date • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer

The phase 1 trial demonstrated pharmacokinetic (PK) bioequivalence of SB27 to both E.U.- and U.S.-sourced Keytruda in 163 patients with stage II or IIIA NSCLC following surgery and adjuvant platinum-based chemotherapy. (Korea Biomedical Review) - "Participants received SB27 or Keytruda every three weeks for up to 51 weeks."

P1 data • PK/PD data • Non Small Cell Lung Cancer

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) - P3 | N=555 | Active, not recruiting | Sponsor: Samsung Bioepis Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2027 ➔ Sep 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Enrollment closed • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 (clinicaltrials.gov) - P1 | N=163 | Active, not recruiting | Sponsor: Samsung Bioepis Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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 (clinicaltrials.gov) - P1 | N=135 | Recruiting | Sponsor: Samsung Bioepis Co., Ltd. | Trial completion date: Dec 2025 ➔ Oct 2026 | Trial primary completion date: May 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Samsung Epis and Celltrion Speed Up Development of 'Keytruda' Biosimilar [Google translation] (Hankyung) - "Celltrion accelerates development ahead of expiration of material patent, receives clinical approval from US FDA, develops and launches domestically within 3 years....It treats melanoma, non-small cell lung cancer, head and neck cancer...Samsung Epis conducts domestic phase 1 clinical trials, simultaneously conducts global phases 1 and 3....Celltrion submitted a phase 3 clinical trial plan for its Keytruda biosimilar 'CT-P51' to the European Medicines Agency (EMA) at the end of August. The plan is to obtain approval for all indications for which the original drug has been approved and to expand the market and sales....Not only Celltrion, but also Samsung Bioepis is accelerating the clinical trial of its Keytruda biosimilar 'SB27'."

New P1 trial • New P3 trial • Head and Neck Cancer • Melanoma • Non Small Cell Lung Cancer

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) - P3 | N=616 | Recruiting | Sponsor: Samsung Bioepis Co., Ltd.

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab) (GlobeNewswire) - "Samsung Bioepis...announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing Keytrudai (pembrolizumab). The Phase 3 clinical trial for SB27 is a randomized, double-blind, parallel group, multicenter studyii to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer. Patients will be randomized in a 1:1 ratio to receive either SB27 or Keytruda 200 mg intravenously every 3 weeks concurrently with chemotherapy (pemetrexed 500 mg/m2 with vitamin supplementation intravenous (IV) infusion over 10 minutes every 3 weeks and carboplatin area under the curve [AUC] 5 IV infusion over 15-60 minutes every 3 weeks for the first 4 cycles)."

Trial status • Lung Non-Squamous Non-Small Cell Cancer

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 (clinicaltrials.gov) - P1 | N=135 | Recruiting | Sponsor: Samsung Bioepis Co., Ltd.

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Samsung Bioepis begins P1 trial of Keytruda biosimilar (Korea Biomedical Review) - "Samsung Bioepis has begun clinical development of its next flagship pipeline, a biosimilar of Keytruda (pembrolizumab). Samsung Bioepis said Wednesday that the company had initiated a global phase 1 clinical trial of SB27, a Keytruda biosimilar, and its 11th biosimilar pipeline. Samsung Bioepis will recruit 135 patients with non-small cell lung cancer (NSCLC) in four countries, including Korea, to compare the pharmacokinetics, efficacy, and safety of SB27 with the original drug."

Trial status • Non Small Cell Lung Cancer

Korean biotech firms spearhead biosimilar race for MSD’s Keytruda as patent expiry looms (Korea Biomedical Review) - "...Companies from Korea and around the world are venturing into developing biosimilars for Keytruda as the drug's patent is set to expire in the U.S. in 2028 and EU in 2030. Most recently, Samsung Bioepis received approval from the MFDS for phase 1 clinical trials of SB27, its Keytruda biosimilar. This is the first time a Korean company has received clinical approval for a Keytruda biosimilar....Celltrion expressed its intention to develop a biosimilar for Keytruda in 2018 and is currently developing the substance....Chong Kun Dang acquired the domestic rights to a Keytruda biosimilar from Favorex, a Singaporean pharmaceutical company, in September last year and is currently conducting preclinical trials. Based on the preclinical trial results, they will apply for phase 1 clinical trials....MSD is also developing a SC form in preparation for expanding the patent expiration of Keytruda. If these patents are registered, the patent period for Keytruda could be extended beyond 2036."

New P1 trial • Patent • Pipeline update • Oncology