FDA Approvals and Treatment Advancements for Lung Cancer - Episode 4
The FDA has approved Imfinzi for some adults with limited-stage small cell lung cancer.
The Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) for adults with limited-stage small cell lung cancer (SCLC) whose disease did not progress after concurrent platinum-based chemotherapy and radiation therapy.
The late 2024 approval was based on findings form the ADRIATIC trial of 730 patients with limited-stage SCLC. In the 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.
Limited-stage small cell lung cancer: When cancer is confined to one lung or one side of the chest.
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.
The most common side effects, which occurred in at least 20% of patients, included radiation pneumonitis, fatigue or pneumonitis.
As part of the “Speaking Out” video series, CURE® spoke with Andrew Ciupek, associate director of clinical research at GO2 for Lung Cancer, about the FDA’s approval of Imfinzi.
“One of the big focuses of research for limited-stage small skin cancer is, how can we improve our initial treatment to reduce or prevent the chance that [the cancer] might come back after that initial treatment? And that's where this new approval for Imfinzi fits in,” he said.
Most limited-stage small SCLC, Ciupek said, will be treated by chemoradiation, or the combination of chemotherapy infusions and targeted radiation to the tumor in the chest.
“The idea of this approval after that is complete, if everything looks good and you responded to that initial chemoradiotherapy, the cancer doesn't seem to be getting bigger, then they can start a course of immunotherapy, specifically Imfinzi, and that can be given afterwards,” Ciupek said. “What they think is that by adding that additional treatment after your first treatment, something that they call maintenance therapy, you will extend the benefit of your first treatment. And hopefully, by giving Imfinzi together with initial chemoradiation, it'll take longer, or it may prevent the cancer from coming back and reoccurring at a later stage.”
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