AstraZeneca's Imfinzi (Durvalumab) Receives EU Approval for New 4-Week Fixed-Dose Regimen in Unresectable NSCLC

January 15, 2021 /Bio ValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced that the European Commission (EC) has approved a new dosing option for the anti-PD-L1 therapy Imfinzi (brand name: Imfinzi; generic name: durvalumab), consisting of a fixed dose of 1500 mg administered once every 4 weeks, for its approved indications in non-small cell lung cancer (NSCLC). Specifically, this applies to patients whose disease has not progressed following platinum-based chemoradiotherapy (CRT) and whose tumors express PD-L1 (≥1%).Tumorcells) with locally advanced or unresectable NSCLC in adult patients.

This new dosing regimen (fixed dose of 1500 mg once every 4 weeks) is consistent with the approved dose for extensive-stage small cell lung cancer (ES-SCLC) (fixed dose of 1500 mg) and can be used as an alternative to the weight-based dosing regimen of 10 mg/kg once every 2 weeks in patients with locally advanced, unresectable NSCLC weighing >30 kg.

In terms of U.S. regulatory approval, in November 2020, the aforementioned dosing regimen for Imfinzi (a fixed dose of 1500 mg every 4 weeks) was approvedFDAApproved for previously approved indications in NSCLC and prostate cancer. Previously, the approved dosage of Imfinzi for NSCLC and bladder cancer indications was weight-based (10 mg/kg every two weeks). With this approval, Imfinzi offers a new dosing regimen (fixed dose of 1500 mg every four weeks) for patients with unresectable stage III NSCLC following chemoradiotherapy and for patients with previously treated advanced bladder cancer. This regimen aligns with the approved dose for ES-SCLC (fixed dose of 1500 mg) and will be available as an alternative to the weight-based 10 mg/kg every-two-weeks regimen for patients weighing >30 kg. This dosing regimen is currently under regulatory review in other countries and regions.

This new 4-week dosing regimen will enable physicians to halve the number of clinic visits and provide patients with a more convenient treatment option. United StatesFDAapproval and the EU EC approval, both based on multiple ImfinziClinical Trialdata, including results from the Phase III PACIFIC trial in NSCLC and the Phase III CASPIAN trial in ES-SCLC, with the latter employing a fixed-dose regimen of 1500 mg administered every 4 weeks during the maintenance phase.

AstraZenecaTumorDave Fredrickson, Executive Vice President of the Business Unit, stated, “We are pleased to provide a once-every-four-weeks dosing regimen for lung cancer patients in Europe to meet their urgent needs and help them maintain continuity of care during the COVID-19 pandemic. We are committed to offering treatment options that address the challenges posed by the pandemic to patient care.”

Lung cancer is the leading cause of cancer-related deaths in both men and women, accounting for approximately one-fifth of all cancer deaths. Lung cancer is broadly classified into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with NSCLC comprising approximately 80–85% of cases. Stage III (locally advanced) NSCLC is typically subdivided into stages IIIA, IIIB, and IIIC, based on the extent of local spread and resectability. Unlike stage IV lung cancer, which involves distant metastasis, stage III lung cancer has the potential for clinical cure.

Imfinzi (Yingfeifan, durvalumab) is a humanized PD-L1 monoclonal antibody that blocks the binding of PD-L1 to PD-1 and CD80, thereby blockingTumorImmune escape and release of suppressed immune responses.

To date, Imfinzi has been approved in multiple countries (including the United States, Japan, China, and the entire European Union) for the curative treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Additionally, Imfinzi has been approved in more than 10 countries, including the United States, for the treatment of patients with advanced bladder cancer who have previously received platinum-containing chemotherapy.

Based on data from the Phase III CASPIAN trial, Imfinzi in combination with standard-of-care (SoC) chemotherapy as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) has received approval in the United States, the European Union, Japan, and several other countries.

Currently, AstraZeneca is conducting a large-scale clinical program to evaluate Imfinzi as monotherapy and in combination with tremelimumab and other agents for the treatment of NSCLC, SCLC, bladder cancer, head and neck cancer,Liver Cancer, cervical cancer, biliary tract cancer, and other solid tumors.Tremelimumab is a human monoclonal antibody that targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), blocks CTLA-4 activity, promotes T-cell activation, and initiatesTumorImmune response, promoting cancer cell death. Tremelimumab and Bristol-Myers Squibb's marketed antibody drug Yervoy (ipilimumab) target the same checkpoint, CTLA-4. (Bioon.com)

Original source: Imfinziapproved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer