UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has received approval from the European Union (EU) for its PD-L1 inhibitor Imfinzi (durvalumab) as a monotherapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
Clinical Need and Approval Significance
SCLC is a highly aggressive form of lung cancer, with around 8,000 people across the five major European countries diagnosed with LS-SCLC annually. Despite initial responses to standard-of-care chemotherapy and radiotherapy, the disease typically recurs and progresses rapidly. The prognosis for LS-SCLC is particularly poor, with only 15-30% of patients surviving five years post-diagnosis. This approval marks a significant advancement in treatment options for this patient population.
Clinical Trial Results
The ADRIATIC study demonstrated compelling efficacy for Imfinzi. Results showed a 27% reduction in the risk of death compared to placebo, with an estimated median overall survival (OS) of 55.9 months for Imfinzi versus 33.4 months for placebo. At three years, 57% of patients treated with Imfinzi were alive compared to 48% in the placebo group. These robust data have supported regulatory approvals globally, including in the United States.
Market Impact
Imfinzi is the first and only immunotherapy approved for LS-SCLC in the EU. This milestone is expected to transform the treatment landscape for this aggressive cancer, offering patients a new hope for improved survival outcomes.-Fineline Info & Tech
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