AstraZeneca's Durvalumab Receives FDA Approval for Limited-Stage Small Cell Lung Cancer

Dec 05, 2024 17:20 CST Updated 17:20

AstraZeneca

Biopharmaceutical Manufacturer

On December 5, AstraZeneca announced that the new indication for its PD-L1 monoclonal antibody Durvalumab (Imfinzi) has been approved by the FDA in the United States for the treatment ofAdult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed after concurrent platinum-based chemotherapy and radiation therapy, becomingThe first and only immunotherapy regimen for LS-SCLC.

Imfinzi（Durvalumab，DurvalumabIt is a key immunotherapy by AstraZeneca, which has been approved in multiple countries for the treatment of various types of lung cancer.It is the global standard therapy for patients with stage III unresectable NSCLC whose disease has not progressed after chemoradiotherapy.

This approval is based on the results of the ADRIATIC Phase III clinical trial. ADRIATIC is a randomized, double-blind, placebo-controlled, multicenter global Phase III trial designed toEvaluate the efficacy of Imfinzi monotherapy and Imfinzi combined with tremelimumab (CTLA4 antibody) versus placebo in 730 LS-SCLC patients who did not progress after cCRT.

The results showed that, based on OS comparison, Imfinzi reduced the risk of death by 27% compared to placebo.The median OS for patients treated with Imfinzi was 55.9 months, compared to 33.4 months in the placebo group.It is estimated thatAmong patients treated with Imfinzi, 57% survived within three years (vs 48%).。

Based on the PFS comparison, Imfinzi reduced the risk of disease progression or death by 24% compared to placebo.The median PFS for patients treated with Imfinzi was 16.6 months, compared to 9.2 months in the placebo group.It is estimated that in patients receiving Imfinzi treatment,46% of patients did not experience disease progression within two years (vs 34%).

In terms of safety,The safety of Imfinzi is generally controllable., consistent with the known safety profile of the drug, no new safety signals were observed.

In May 2017, Imfinzi was first approved by the U.S. FDA for marketing, intended for patients with advanced bladder cancer who have already received treatment. Since then, AstraZeneca has continued to expand its new indications, including:

Combination of Tislelizumab and platinum-based chemotherapy for the treatment of adult patients with metastatic NSCLC without EGFR-sensitive mutations or ALK rearrangements;
For the treatment of patients with unresectable Stage III NSCLC;
In combination with standard-of-care (SoC) chemotherapy, etoposide plus carboplatin or cisplatin, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC);
In combination with chemotherapy (gemcitabine plus cisplatin) for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC);
In combination with tislelizumab for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC);
In combination with carboplatin and paclitaxel, followed by monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) primary advanced or recurrent endometrial cancer.

Lung cancer is broadly divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), with approximately 15% of cases being small cell lung cancer (SCLC). Small cell lung cancer (SCLC) is a highly aggressive form of lung cancer.

Limited-stage small cell lung cancer (LS-SCLC, stages I-III) is typically defined as being confined to one side of the lung or one side of the thoracic cavity, accounting for approximately 30% of small cell lung cancer (SCLC).

Despite an initial response to chemotherapy and radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC), the prognosis remains poor following treatment with standard curative concurrent chemoradiotherapy (cCRT). This type of cancer often recurs and progresses rapidly.The 5-year survival rate for LS-SCLC patients after diagnosis is only 15%-30%.。

References: AstraZeneca Official Website, Insight Database

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