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Imfinzi was approved by the FDA for the treatment of adults with limited-stage small cell lung cancer without disease progression after chemotherapy and radiation.
The FDA has approved Imfinzi for the treatment of adults with limited-stage small cell lung cancer who did not progress after concurrent platinum-based chemotherapy and radiation therapy.
The Food and Drug Administration (FDA) approved Imfinzi (durvalumab) for the treatment of adults with limited-stage small cell lung cancer whose disease did not progress after concurrent platinum-based chemotherapy and radiation therapy.
The approval, which was announced in a notice from the FDA, was based on findings from the ADRIATIC trial. In this trial, 730 patients with limited-stage small cell lung cancer without disease progression after concurrent platinum-based chemotherapy and radiation therapy were randomly assigned to receive single-agent Imfinzi, Imfinzi plus Imjudo (tremelimumab) or placebo.
The major focus of the trial was to assess overall survival and progression-free survival, according to the agency. In this trial, Imfinzi demonstrated a statistically significant improvement in overall survival compared with placebo, with a median overall survival of 55.9 months and 33.4 months, respectively. Imfinzi also showed a statistically significant improvement in progression-free survival compared with placebo, with a median of 16.6 months and 9.2 months, respectively.
The most common side effects, which occurred in at least 20% of patients, included radiation pneumonitis, fatigue or pneumonitis.
Progression-free survival: the time during and after treatment when a patient with cancer lives with the disease without worsening.
Overall survival: the time from diagnosis or the start of treatment when a patient with cancer is still alive.
Radiation pneumonitis: inflammation of the lungs, which may be caused from radiation therapy.
Prophylactic cranial irradiation: radiation therapy to the head to potentially reduce the risk that the cancer will spread to the brain.
According to the FDA, the recommended dose of Imfinzi is 1,500 milligrams every four weeks for patients who weigh at least 30 kilograms and 20 milligrams per kilogram every four weeks for those who weigh less than 30 kilograms. Treatment is recommended until disease progression or unacceptable toxicity, for a maximum of 24 months.
Findings from the ADRIATIC trial were presented at the 2024 European Society for Medical Oncology Congress in September.
“The magnitude of benefit with [Imfinzi] versus placebo was consistent within the [prophylactic cranial irradiation] and radiotherapy subgroups and varied somewhat between the chemotherapy subgroups. Multivariate analyses showed no significant interactions between [Imfinzi] treatment effect and PCI or concurrent [CRT] subgroups,” Suresh Senan, a professor of Clinical Experimental Radiotherapy at the Amsterdam University Medical Centers (VUmc location) in The Netherlands, said in a presentation on these data. “[Imfinzi] demonstrated consistent benefit versus placebo irrespective of prior PCI use and concurrent [CRT] components, further supporting consolidation [Imfinzi] as the new standard of care in [LS-SCLC].”
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