A NEW treatment for limited-stage small cell lung cancer (LS-SCLC) has been recommended for approval in the European Union following positive results from a Phase III trial. The recommendation, based on the ADRIATIC trial, offers new hope for patients with this aggressive cancer, where prognosis remains poor despite current treatment options.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on a monotherapy treatment option for LS-SCLC, based on data showing a significant survival benefit. In the ADRIATIC trial, this treatment reduced the risk of death by 27% compared to placebo (hazard ratio 0.73, 95% CI 0.57-0.93; p=0.0104). Median overall survival (OS) was 55.9 months for patients receiving the treatment versus 33.4 months for those on placebo. At the three-year mark, 57% of patients receiving the therapy were still alive, compared to 48% of those in the placebo group.
Additionally, the treatment reduced the risk of disease progression or death by 24% (hazard ratio 0.76, 95% CI 0.61-0.95; p=0.0161). Patients receiving the treatment had a median progression-free survival (PFS) of 16.6 months, compared to 9.2 months for those on placebo. After 2 years, 46% of patients in the treatment group had not experienced disease progression, versus 34% in the placebo group.
LS-SCLC is known for its rapid progression despite initial treatment with chemotherapy and radiotherapy. With only a small percentage of patients surviving 5 years post-diagnosis, this new treatment represents a potential breakthrough. The ADRIATIC trial is the first Phase III study in decades to show a survival benefit for patients with limited-stage disease.
The safety profile of the treatment was consistent with its known side effects, with no new safety concerns identified. This development offers a promising new option for the treatment of LS-SCLC in the European market and is already approved in the United States and other regions based on these findings.
Reference: AstraZeneca. Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer. 2025. Available at: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-recommended-for-eu-approval-for-ls-sclc.html. Last accessed: February 4, 2025.
Anaya Malik | AMJ
