AstraZeneca's Imfinzi (Durvalumab) Nears EU Approval for New Every-4-Weeks 1500mg Dosing Regimen in Unresectable NSCLC

December 16, 2020 /Bio ValleyBIOON/ --AstraZeneca(AstraZeneca) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval of a new dosing option for the anti-PD-L1 therapy Imfinzi (brand name: Imfinzi; generic name: durvalumab), administered as a fixed dose of 1500 mg 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 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). Upon approval, this new dosing regimen will be available as an alternative to the weight-based regimen of 10 mg/kg administered every 2 weeks for patients with locally advanced, unresectable NSCLC weighing >30 kg.

In terms of U.S. regulatory affairs, this November, the aforementioned dosage regimen of Imfinzi (1500 mg fixed dose 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 2 weeks). With this approval, Imfinzi offers a new dosing regimen (fixed dose of 1500 mg every 4 weeks) for patients with unresectable stage III NSCLC following chemoradiotherapy and for patients with previously treated advanced bladder cancer. This regimen is consistent with the approved dosage for ES-SCLC (fixed dose of 1500 mg) and will be available as an alternative to the weight-based 10 mg/kg every-2-weeks regimen for patients weighing >30 kg. Currently, this dosing regimen is also under regulatory review in other countries and regions.

This new 4-week dosing regimen will allow physicians to halve the number of clinic visits and provide patients with a more convenient treatment option. USFDAThe approval and the CHMP’s recommendation for approval are 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.

José Baselga, Executive Vice President of Research and Development at AstraZeneca, stated: “The once-every-4-weeks dosing regimen will reduce the risk of exposure to infection in healthcare settings, further strengthening our efforts to ensure that cancer patients at high risk of complications receive continuous care during the pandemic. We look forward to providing a new dosing option for patients with non-small cell lung cancer (NSCLC) in Europe by reducing the frequency of hospital visits through extending the dosing interval from once every two weeks to once every four weeks.”

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 SCLC comprising about 15% 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 evasion 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, and 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), blocking CTLA-4 activity, promoting T-cell activation, and initiatingTumorImmune 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: Imfinzi recommended forapproval in the EU by CHMP for less-frequent, fixed-dose use in unresectable non-small cell lung cancer