AstraZeneca Plc, the renowned British pharmaceutical company, announced on Thursday the approval by the U.S. Food and Drug Administration for their drug Imfinzi (durvalumab). This approval allows for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose condition has not worsened following concurrent platinum-based chemotherapy and radiation therapy.
In the United States, Imfinzi stands as the inaugural and sole immunotherapy option for LS-SCLC patients, a cancer known for its rapid recurrence and progression, despite initial responsiveness to conventional chemotherapy and radiotherapy.
AstraZeneca highlighted the grim outlook for LS-SCLC, with only 15-30% of patients surviving five years post-diagnosis.
The FDA's decision was informed by data from the ADRIATIC Phase III trial, an extensive global study that was randomised, double-blind, and placebo-controlled. It assessed the efficacy of Imfinzi alone and alongside Imjudo (tremelimumab) against a placebo for LS-SCLC patients post-chemoradiation therapy.
Findings from the trial indicated a 27% reduction in the risk of mortality compared to the placebo group. Additionally, Imfinzi lowered the risk of disease progression or death by 24% in comparison to the placebo.
These results were unveiled during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the New England Journal of Medicine.
Prior to this, Imfinzi had been granted the FDA's Priority Review and Breakthrough Therapy Designation.
In addition to the U.S., the drug is approved in Switzerland based on the ADRIATIC trial results. There are ongoing regulatory evaluations for Imfinzi in the EU, Japan, and several other countries.
Currently, Imfinzi is the only immunotherapy authorized for both limited- and extensive-stage small cell lung cancer.
Professor Suresh Senan of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers, who served as the international coordinating investigator for the trial, remarked, "Durvalumab is the first and only systemic therapy after curative-intent, platinum-based chemoradiotherapy to demonstrate enhanced survival for patients with this aggressive lung cancer. This groundbreaking discovery marks the first significant advancement in this disease in forty years. The ADRIATIC trial indicated that 57% of patients were still living three years after treatment with durvalumab, highlighting the transformative potential of this medication in this context."
