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

Celltrion has secured U.S. FDA acknowledgment of an amended Phase 3 trial protocol for CT‑P51, its biosimilar to Merck’s immuno-oncology drug Keytruda, in previously untreated metastatic non-squamous non-small cell lung cancer (TipRanks) - "The global, double-blind, randomized trial will enroll 220 patients over a two-year treatment period to compare the efficacy and safety of CT‑P51 against the reference product. The protocol amendment approval marks a step forward in Celltrion’s strategy to build a portfolio of high-value oncology biosimilars in the U.S. market."

Clinical protocol • Non Small Cell Lung Cancer

Celltrion seeks South Korea approval for Keytruda biosimilar CT-P51 (Chosun Biz) - "The company's application for 'CT-P51' covers Keytruda's major indications, including Non-small cell lung cancer (NSCLC), melanoma, gastric cancer and head and neck cancer. In a clinical trial involving 228 patients with melanoma who had undergone complete resection, it confirmed the pharmacokinetic (PK) equivalence of CT-P51 and Keytruda, and said similar results were observed for safety and immunogenicity."

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

Celltrion has terminated the European Phase 3 clinical trial of ‘CT-P51,’ a biosimilar candidate for the immunotherapy drug ‘Keytruda (ingredient name pembrolizumab),’ early and voluntarily withdrawn its clinical trial plan. (Business Korea) - "Celltrion stated, 'Patient recruitment for the global Phase 3 clinical trial has already been completed, and as European Union (EU) countries were excluded from the participating countries, there is no longer a need to maintain the trial plan submitted to the EMA'....The development of CT-P51 will continue to be pursued. Celltrion plans to comparatively evaluate the efficacy and safety between CT-P51 and Keytruda through the ongoing global Phase 3 trial in participating countries outside the EU."

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

A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer (clinicaltrials.gov) - P3 | N=225 | Active, not recruiting | Sponsor: Celltrion | Recruiting ➔ Active, not recruiting | N=606 ➔ 225

Enrollment change • Enrollment closed • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pembrolizumab in MarginalzoneLymphoma A MULTICENTER OPEN LABEL SINGLE-ARM PHASE II STUDY (clinicaltrials.gov) - P2 | N=22 | Terminated | Sponsor: University of Ulm | Phase classification: P=N/A ➔ P2

Phase classification • Extranodal Marginal Zone Lymphoma • Hematological Malignancies • Lymphoma • Marginal Zone Lymphoma • Neutropenia • Oncology • CD20

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

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

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