Imfinzi approval was recently expanded by the FDA to include the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi has previously been approved for patients with non-small cell lung cancer and extensive stage SCLC as well as other solid tumors.
The standard initial treatment for LS-SCLC has been chemotherapy and radiation given at the same time. Although this treatment tends to work well at first, the cancer often comes back quickly, at which point it has typically spread throughout the body.
The expanded approval of Imfinzi is the only FDA-approved immunotherapy combination for patients with LS-SCLC and provides a new standard of care for patients with early-stage SCLC. The approval was based on results from the phase 3, double-blind, randomized, placebo-controlled ADRIATIC study which demonstrated a 27% reduction in the risk of death versus placebo. Durvalumab, given as an infusion every 4 weeks, showed no unexpected side effects. The side effects were consistent with those typically seen with durvalumab and other immunotherapies that boost the immune system.
Patients receiving Imfinzi experienced inflammatory conditions in the lungs, skin, and thyroid. Serious immune-related side effects occurred in 5% of the durvalumab group compared to 2% in the placebo group. A significant concern is pneumonitis, a serious and potentially fatal lung inflammation that Imfinzi can cause. This condition is also common in patients who have recently undergone chest radiation, as was the case in this study. In the ADRIATIC trial, pneumonitis developed in 38% of the durvalumab group and 30% of the placebo group. Overall, about 25% of participants in both groups experienced a serious side effect. The side effects were severe enough to cause 16% of patients in the durvalumab group and 11% in the placebo group to discontinue treatment. Read more about the ADRIATIC study here.
About Imfinzi (durvalumab)
Imfinzi is a precision cancer immunotherapy designed to bind with a protein called PD-L1, which is expressed on cancer cells and tumor-infiltrating immune cells, blocking its interaction with the PD-1 receptor. By inhibiting PD-L1, Imfinzi may enable the activation of T cells.
This new treatment offers hope to patients with this type of lung cancer, which has traditionally had a difficult prognosis.
More Reading
Immunotherapy After Chemoradiotherapy Promising in Limited-Stage Small Cell Lung Cancer
Overview of Small Cell Lung Cancer
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References:
Cheng Y, et al. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024;391(14):1313-1327.
