pembrolizumab biosimilar (CT-P51) / Celltrion - LARVOL DELTA

A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer (clinicaltrials.gov) - P3 | N=606 | Recruiting | Sponsor: Celltrion

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

Celltrion and Samsung Bioepis intensify Korean biosimilar race for Keytruda (Korea Biomedical Review) - "Among Korean contenders, Celltrion gave the most recent update, stressing that it has received approval from the Ministry of Food and Drug Safety to initiate a phase 3 clinical trial of its Keytruda biosimilar candidate CT-P51 on Monday. The trial will enroll 606 patients with metastatic non-squamous NSCLC who have not received prior systemic therapy....The study is designed to compare the efficacy and safety of CT-P51 and Keytruda over a two-year period, using a randomized, double-blind, active-controlled, parallel-group design."

New P3 trial • Lung Non-Squamous Non-Small Cell Cancer

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

Celltrion’s CT-P51 biosimilar to Keytruda receives FDA nod for phase 3 study (Korea Biomedical Review) - "Celltrion said Monday that it has received approval from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application for a phase 3 clinical trial of CT-P51, its biosimilar to Keytruda (pembrolizumab)....Keytruda, a PD-L1 inhibitor, is an immunotherapy treatment approved for a wide range of cancers, including NSCLC, gastric cancer, and head and neck cancer."

IND • Gastric Cancer • Non Small Cell Lung Cancer • Oncology • Squamous Cell Carcinoma of Head and Neck

Celltrion submits IND for P3 study of Keytruda biosimilar in US (Korea Biomedical Review) - "Celltrion said it submitted an investigational new drug (IND) application to the U.S. FDA for the phase 3 clinical trial of CT-P51, its Keytruda (ingredient: pembrolizumab) biosimilar....This global clinical trial will evaluate the efficacy equivalence between CT-P51 and the original Keytruda in 606 patients with metastatic non-small cell lung cancer (NSCLC)....The patent for Keytruda is set to expire in the U.S. in November 2029 and in Europe in January 2031....'The global phase 3 IND submission for CT-P51 will help the company expand its oncology portfolio and secure additional future growth drivers,'..."

IND • Patent • Non Small Cell Lung Cancer