AstraZeneca's Imfinzi Receives EU Approval as First and Only Immunotherapy for Limited-Stage Small Cell Lung Cancer
AstraZeneca
Biopharmaceutical Manufacturer
Today, AstraZeneca announced that its immunotherapy drug Imfinzi® (generic name: durvalumab) has been approved in the European Union as a monotherapy for adults whose disease has not progressed after receiving platinum-based chemoradiotherapy (CRT).Limited-stage small cell lung cancer（LS-SCLC）。This historic approval makes Imfinzi® the first and only immunotherapy approved in the EU for this patient population.
The approval was based on the positive results of the ADRIATIC Phase III clinical trial. The trial results were published in the prestigious international medical journal, The New England Journal of Medicine. The trial data showed that, compared with placebo, Imfinzi® significantly reduced the risk of death by 27%.In patients treated with Imfinzi®, the three-year survival rate was as high as 57%, compared to only 48% in the placebo group. Additionally, Imfinzi® reduced the risk of disease progression or death by 24%, with a median progression-free survival (PFS) of 16.6 months, compared to just 9.2 months in the placebo group.At two years, 46% of patients treated with Imfinzi® had not experienced disease progression, compared to 34% in the placebo group.
Small cell lung cancer is a highly aggressive type of lung cancer, accounting for approximately 15% of all lung cancer cases. In the five major European countries, around 8,000 people are diagnosed with and receive treatment for limited-stage small cell lung cancer each year. Despite an initially good response to standard chemoradiotherapy, limited-stage small cell lung cancer often recurs and progresses rapidly. With a very poor prognosis, only 15-30% of patients survive five years after diagnosis.
Imfinzi® (Durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein, blocking the interaction between PD-L1 and PD-1 and CD80 proteins, thereby countering the tumor's immune evasion mechanism and relieving the suppression of immune responses.
Based on the results of the ADRIATIC trial, Imfinzi® has been approved in the United States and several other countries for the treatment of limited-stage small cell lung cancer. Regulatory submissions are also underway in Japan and other countries. Additionally, based on the results of the CASPIAN Phase III trial, Imfinzi® has also been approved in combination with chemotherapy for the treatment of extensive-stage small cell lung cancer.
Imfinzi® has also made significant progress in other tumor fields, including:
• As the global standard treatment in the radical treatment of unresectable stage III non-small cell lung cancer (NSCLC) patients who have not progressed after chemoradiotherapy.
• In combination with neoadjuvant chemotherapy as a perioperative treatment for resectable non-small cell lung cancer.
• In combination with a short course of Imjudo® and chemotherapy for the treatment of metastatic non-small cell lung cancer.
• In combination with chemotherapy (gemcitabine plus cisplatin) for locally advanced or metastatic biliary tract cancer.
• In combination with Imjudo® for unresectable hepatocellular carcinoma (HCC), and as monotherapy for unresectable HCC in Japan and the EU.
• In the MATTERHORN Phase III trial for resectable gastric cancer and gastroesophageal junction cancer, the primary endpoint of event-free survival was met when combined with standard-of-care chemotherapy.
• In combination with chemotherapy, followed by Imfinzi® monotherapy, as a first-line treatment for previously untreated advanced or recurrent endometrial cancer (only for mismatch repair deficient disease in the United States and the European Union).
• In the EU and Japan, in combination with chemotherapy, followed by combined treatment with Lynparza® (olaparib) and Imfinzi®, for patients with mismatch repair proficient advanced or recurrent endometrial cancer.
Since its initial approval in 2017, more than 374,000 patients have been treated with Imfinzi®. Imfinzi® is currently being evaluated in a broad development program as monotherapy and in combination with other anticancer therapies for the treatment of small cell lung cancer, non-small cell lung cancer, bladder cancer, breast cancer, various gastrointestinal and gynecological cancers, and other solid tumors.
Reference: Company official website
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