First Immunotherapy Approval for Limited-stage Small Cell Lung Cancer
The FDA approved durvalumab for some patients with previously treated limited-stage small cell lung cancer.
The U.S. Food and Drug Administration (FDA) has approved durvalumab (Imfinzi) for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) that did not progress after platinum-based chemotherapy and radiation.
This is the first FDA immunotherapy approval for patients with LS-SCLC.
Durvalumab is an immune checkpoint inhibitor, a type of immunotherapy that can improve the immune system’s ability to recognize and destroy cancer cells, and was previously approved as part of a treatment combination for extensive-stage SCLC, among other lung cancer indications.
The current approval was based on results from the randomized, double-blind, placebo-controlled phase III ADRIATIC study, which enrolled 730 LS-SCLC patients with previously treated, but not progressive, disease. Patients were randomly assigned (1:1:1) to receive either durvalumab alone, durvalumab in combination with tremelimumab (Imjudo), or placebo.
Compared with the placebo, durvalumab alone reduced the risk of death and disease progression during the study period by 27% and 24%, respectively. Half of the patients treated with durvalumab alone survived at least 55.9 months versus 33.4 months for placebo-treated patients. The median time to disease progression was 16.6 months and 9.2 months in the durvalumab alone and placebo groups, respectively.
The recommended dose for durvalumab is 1,500 mg every four weeks for those weighing at least 30 kg and 20 mg per kg body weight every four weeks for those weighing under 30 kg, until disease progression or unacceptable toxicity or for a maximum of 24 months.
SCLC is a fast-growing form of lung cancer . Limited stage describes small cell lung cancers that remain confined to one side of the chest. According to federal statistics, it was estimated that 234,580 individuals would be diagnosed with lung cancer and 125,070 would die of the disease in the United States in 2024.
The FDA rendered its decision on December 4, 2024. Check this resource for updated information on all therapeutics regulated by the FDA.
