First-in-Decades Breakthrough: AstraZeneca’s Imfinzi Receives CHMP Positive Opinion for Limited-Stage Small Cell Lung Cancer in the EU

Feb 04, 2025 08:35 CST Updated 08:35

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXiEdited by Kant Content Team

AstraZeneca announced today,Its heavyweight immunotherapy Imfinzi (durvalumab)Has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending approval in the European Union (EU) as a monotherapy,For the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after receiving platinum-based chemoradiotherapy (CRT).。

This recommendation is based on the results of the Phase 3 clinical trial ADRIATIC published in The New England Journal of Medicine. The results showed,Compared with placebo, Imfinzi reduced the risk of death by 27% (HR=0.73; 95% CI: 0.57–0.93; p=0.0104). The estimated median overall survival (OS) was 55.9 months in the Imfinzi group and 33.4 months in the placebo group. The estimated three-year survival rate was 57% in the Imfinzi group and 48% in the placebo group.

At the same time, Imfinzi reduced the risk of disease progression or death by 24%. The median progression-free survival (PFS) was 16.6 months in the Imfinzi group and 9.2 months in the placebo group. The estimated proportion of patients who had not experienced disease progression after two years was 46% in the Imfinzi group and 34% in the placebo group.

Small Cell Lung Cancer (SCLC) is a highly aggressive type of lung cancer. Even after an initial good response to standardized chemotherapy and radiotherapy, Limited-Stage Small Cell Lung Cancer (LS-SCLC) often recurs and progresses rapidly. The prognosis for LS-SCLC is particularly poor, with only 15%-30% of patients surviving five years post-diagnosis.

Dr. Suresh Senan, Professor of Radiation Oncology at the Amsterdam University Medical Center in the Netherlands and Principal Investigator of the ADRIATIC trial, stated:ADRIATIC is the first Phase 3 trial in decades to demonstrate a survival benefit in limited-stage small cell lung cancer.，Patients receiving Imfinzi had a 27% lower risk of death."

Imfinzi is a humanized monoclonal antibody. By binding to PD-L1, it blocks the interaction between PD-L1 and PD-1 as well as CD80 proteins, thereby inhibiting the tumor's immune escape mechanism.It has already been approved in the United States last December.FDA Approval, for the treatment of adult patients with limited-stage small cell lung cancer whose condition has not progressed after receiving platinum-based concurrent chemoradiotherapy.

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References:

[1] Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer. Retrieved February 3, 2025, from https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-recommended-for-eu-approval-for-ls-sclc.html

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