June 30, 2022

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Tumor immunotherapy: EU will apprve AstraZeneca Imfinzi’s regimen soon!

Tumor immunotherapy: EU will apprve AstraZeneca Imfinzi’s regimen soon!

Tumor immunotherapy: EU will apprve AstraZeneca Imfinzi’s regimen soon! Upgrade of tumor immunotherapy! AstraZeneca Imfinzi’s new dosing regimen (1500mg once every 4 weeks) will be approved by EU soon!

Tumor immunotherapy: EU will apprve AstraZeneca Imfinzi's  regimen soon!

AstraZeneca recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review opinion recommending the approval of the anti-PD-L1 therapy Imfinzi (Infinzi, generic name: durvalumab, durvalumab, durvalumab) Anti) A new dosage option, a fixed dose of 1500 mg once every 4 weeks, for the approved indications of non-small cell lung cancer (NSCLC), specifically: no progression of the disease after receiving platinum-containing radiotherapy and chemotherapy (CRT), tumor Adult patients with locally advanced or unresectable NSCNC expressing PD-L1 (≥1% tumor cells).

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

In terms of US regulation, in November this year, Imfinzi’s above-mentioned dosage regimen (a 4-week fixed dose of 1500 mg) was approved by the FDA for the previously approved NSCLC and prostate cancer indications. Previously, the approved dose of Imfinzi in NSCLC and bladder cancer indications was based on body weight (10 mg/kg, once every 2 weeks). With this approval, Imfinzi can provide a new dosing regimen (fixed dose of 1500 mg, once every 4 weeks) in patients with unresectable stage III NSCLC after chemotherapy and radiotherapy and in patients with advanced bladder cancer who have previously received treatment ), which is consistent with the approved dose of ES-SCLC (fixed dose of 1500 mg). This program will be provided to patients with a body weight of> 30 kg as an alternative to a weight-based dose of 10 mg/kg once every 2 weeks. Currently, this dosage regimen is also undergoing regulatory review in other countries and regions.

This new 4-week dosing regimen will give doctors the option to reduce the number of visits by half and provide patients with more convenient treatment options. The US FDA’s approval and the CHMP’s recommended approval are based on the data of a number of Imfinzi clinical trials, including the results of the NSCLC Phase III PACIFIC trial and the ES-SCLC Phase III CASPIAN trial. The latter trial is fixed every 4 weeks during the maintenance period A dosage regimen of 1500 mg.

 

José Baselga, executive vice president of AstraZeneca’s R&D department, said: “The 4-week dosing regimen will reduce the risk of exposure to infection in the medical environment and further strengthen our efforts to ensure that cancers with a high risk of complications during the pandemic Patients receive continuous care. We look forward to providing a new dosing option for NSCLC patients in Europe, reducing the number of visits by extending the dosing time from once every 2 weeks to once every 4 weeks.”

Lung cancer is the leading cause of cancer deaths in men and women, accounting for about one-fifth of all cancer deaths. Lung cancer is roughly divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), of which SCLC accounts for about 15%. Stage III (local progression) NSCLC is usually divided into three types: IIIA, IIIB, and IIIC according to the extent of local metastasis of cancer cells and whether surgery can be performed. Unlike patients with stage IV lung cancer that have already developed distant metastases, stage III lung cancer has the possibility of clinical cure.

 

Imfinzi (Infinzi, Duvalimab) is a humanized PD-L1 monoclonal antibody that can block the binding of PD-L1 to PD-1 and CD80, thereby blocking the escape and release of tumor immunity Suppressed immune response.

Up to now, Imfinzi has been approved in many countries (including the United States, Japan, China, and the entire European Union) for unresectable, stage III non-small cells without disease progression after receiving platinum-based chemotherapy and concurrent radiotherapy Curative treatment for patients with lung cancer (NSCLC). In addition, Imfinzi has also been approved in more than 10 countries, including the United States, for advanced bladder cancer patients who have previously received platinum-containing chemotherapy.

Based on data from the Phase III CASPIAN trial, Imfinzi’s combined standard of care (SoC) chemotherapy for the first-line treatment of extensive-stage non-small cell lung cancer (ES-SCLC) has been approved by the United States, the European Union, Japan and some other countries.

Currently, AstraZeneca is carrying out a large-scale clinical project to evaluate Imfinzi as a monotherapy and a combination therapy with tremelimumab and its drugs for NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumors Treatment.

Tremelimumab is a human monoclonal antibody that targets cytotoxic T lymphocyte antigen 4 (CTLA-4), blocks the activity of CTLA-4, promotes T cell activation, initiates tumor immune responses, and promotes cancer cell death. Tremelimumab and Bristol-Myers Squibb’s listed antibody drug Yervoy (ipilimumab) target the same target CTLA-4.


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