CHMP Recommends Approval of Imfinzi Plus Chemotherapy as First-Line Immunotherapy for Advanced Biliary Tract Cancer in the EU
AstraZeneca
Biopharmaceutical Manufacturer
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
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News on November 21, 2022 /BioValleyBIOON/ -- AstraZeneca recently announced that the European MedicinesManagementThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive review opinion, recommending approval.Anti-PD-L1 Therapy Imfinzi (Generic Name: Durvalumab): Combined with Chemotherapy (Gemcitabine + Cisplatin) for First-Line Treatment of Adult Patients with Unresectable or Metastatic Biliary Tract Cancer (BTC)The CHMP opinion will be submitted to the European Commission (EC) for review, which usually makes a final decision within 2 months.If approved, Imfinzi + chemotherapy will bring the first option for advanced BTC patients in Europe.ImmunityTreatment regimen, this innovative solution has been proven to significantly extend patient survival.
In September 2022, the Imfinzi combined with chemotherapy (gemcitabine + cisplatin) regimen was approved in the United States.FDAApproved for the treatment of adult patients with locally advanced or metastatic BTC. Notably,Imfinzi + chemotherapy is the first immunotherapy regimen approved in the United States for the treatment of advanced BTC.. Currently, this treatment regimen is also undergoing regulatory review in Japan and several other countries.
The positive review opinion of the CHMP is based on the results of the TOPAZ-1 Phase 3 trial. The main results of the trial have been published in The New England Journal of Medicine (NEJM), and updated results were announced at the 2022 European Society for Medical Oncology (ESMO) Congress. The data shows:In patients with advanced BTC, compared with standard-of-care (SoC) chemotherapy, Imfinzi in combination with SoC chemotherapy as a first-line treatment provided a clinically meaningful and durable overall survival (OS) benefit.Moreover, compared with chemotherapy, the combination therapy did not increase discontinuation due to adverse events.
TOPAZ-1 is the first Phase 3 clinical trial: showing that a first-line immunotherapy combination can improve survival in patients with advanced BTC.In the global randomized trial for the treatment of advanced BTC, Imfinzi + chemotherapy is the first immunotherapy combination that has demonstrated significantly superior efficacy compared to standard care.
TOPAZ-1 Phase 3 Study Researcher and Professor of Medical Oncology at the University of Manchester, UK, Juan W. Valle, commented: "This positive review opinion is great news for patients with advanced biliary tract cancer in the EU, who face poor prognoses and limited treatment options. Progress in the clinical treatment of biliary tract cancer has been limited over the past decade, and the combination regimen of Imfinzi with chemotherapy represents a significant advancement for patients. Once approved,This approach should become the new standard of care.。”
Latest Results of TOPAZ-1 Trial
TOPAZ-1 is a randomized, double-blind, placebo-controlled, multi-center, global Phase III trial conducted in 685 adult patients with unresectable, locally advanced or metastatic BTC (including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer; excluding ampullary cancer). The trial is evaluating Imfinzi in combination with SoC chemotherapy (gemcitabine plus cisplatin) and placebo in combination with SoC chemotherapy as first-line treatment options. The trial is being conducted across 105 clinical centers in 17 countries worldwide, including China.
In October 2021, in a pre-specified interim analysis, the trial met the primary endpoint of OS: compared with the chemotherapy group, the risk of death in the Imfinzi + chemotherapy group was reduced by 20% (HR=0.80, 95% CI: 0.66-0.97; two-sided p=0.021), with significant improvement in OS (median OS: 12.8 months vs 11.5 months) and a higher 2-year survival rate (25% vs 10%).
The latest results published at the 2022 ESMO Congress show:After an additional 6.5 months of follow-up, the clinical efficacy further improved. Compared with the chemotherapy group, the Imfinzi + chemotherapy group showed a 24% reduction in the risk of death (HR=0.76, 95% CI: 0.64-0.91), significant improvement in OS (median OS: 12.9 months vs 11.3 months), and an estimated 2-year survival rate that was twice as high (23.6% vs 11.5%). Improvements were observed across all pre-specified subgroups, regardless of disease status, tumor location, or PD-L1 expression. Additionally, OS benefits were observed in patients with stable tumor volume (stable disease) as well as in those with reduced or disappeared tumor volume (responders).
In the trial, the safety of Imfinzi + chemotherapy remained favorable with extended follow-up, and no new safety signals were observed. Treatment-related adverse events of grade 3/4 were experienced by 60.9% of patients in the Imfinzi + chemotherapy group and 63.5% in the chemotherapy group.Compared with chemotherapy alone, the addition of Imfinzi to chemotherapy did not increase the discontinuation rate due to adverse events (8.9% in the combination group vs 11.4% in the chemotherapy group).
Approximately 50,000 people in the United States, Europe, and Japan, and about 210,000 people worldwide areDiagnosisFor BTC. These patients have a poor prognosis, with only about 5%-15% of BTC patients surviving five years. In December 2020, Imfinzi was granted Orphan Drug Designation (ODD) for the treatment of BTC in the United States.
Imfinzi (Yingfanyan, Durvalumab) is a human monoclonal antibody that targets and binds to the programmed cell death ligand 1 (PD-L1), blocking the interaction between PD-L1 and PD-1 and CD80, countering the tumor's immune evasion strategy and releasing the suppression of the immune response.
Based on the results of the Phase 3 PACIFIC study, Imfinzi is the only approved treatment for unresectable locally advanced (Stage III) non-small cellLung Cancer（NSCLC) Immunotherapy as a curative treatment after chemoradiotherapy has now become the global standard of care.
Based on the results of the Phase 3 CASPIAN study, Imfinzi has also been approved in many countries around the world (including the United States, the entire European Union, China, and Japan) for the treatment of extensive-stage small cell lung cancer (ES-SCLC). Additionally, Imfinzi has been approved in multiple countries for the treatment of patients with previously treated advanced bladder cancer. (Bioon.com)
Source of the original text:Imfinzi plus chemotherapy recommended for approval in the EU by CHMP as first immunotherapy regimen for advanced biliary tract cancer