Glossary:
Extensive-stage small cell lung cancer: Cancer has spread throughout the lung to the other lung or other parts of the body.
Limited-stage small cell lung cancer: Cancer that is on one side of the chest.
FDA Approvals and Treatment Advancements for Lung Cancer - Episode 1
What’s On the Horizon for Small Cell Lung Cancer Research?
March 6, 2025
On the heels of two FDA approvals in lung cancer treatments, what innovations are next?
As an expert explained in an interview with CURE, we may be in the midst of a “new era” for small cell lung cancer research. This optimism comes in the wake of the Food and Drug Administration’s (FDA’s) approval of Imdelltra (tarlatamab-dlle) in May 2024 for the treatment of patients with extensive-stage small cell lung cancer (SCLC).
Imdelltra is a type of immunotherapy known as a bispecific T-cell engager, or BiTE therapy, which binds to both cancer cells and immune cells, bringing them into close proximity and allowing the patient’s own T cells to attack tumor cells. The accelerated FDA approval of Imdelltra was for patients with extensive-stage SCLC with disease progression on or after platinum-based chemotherapy.
“With the approval of Imdelltra, [we’re starting to see] something completely different — a new way of treating [SCLC] that has benefit for people [who already] had that first treatment [that] was no longer working well for them. That’s been the cause for a lot of excitement [in this space]. If we [continue] to tackle previous areas, maybe this is a new era for [SCLC] research. I’d love to see the new [FDA] approvals keep pace that are making a real difference for patients,” said Andrew Ciupek, associate director of clinical research at GO2 for Lung Cancer.
Several different types of therapies like Imdelltra are being investigated for SCLC, Ciupek explained in an interview with CURE as part of the “Speaking Out” video series. “Looking forward, depending on how the clinical trials come out, we may see additional options based on bispecific T-cell engagers or combinations that may actually get closer to being available to patients in the next year,” Ciupek said. “I’ve had a lot of optimism about [SCLC] compared [with] previous years.”
In December 2024, the FDA also approved the immunotherapy Imfinzi (durvalumab) for the treatment of adults with limited-stage SCLC whose disease did not progress after concurrent platinum-based chemotherapy and radiation therapy. The pair of approvals mark a sea of change from the norm regarding treatment advancements for SCLC.
“Unfortunately, [SCLC] has been associated with a poor prognosis and has not had as much research advancement in terms of new approvals of therapies compared [with] non-small cell lung cancer,” Ciupek said. “But just last year, we’ve been seeing the approval of new immunotherapy-based options for small cell, and we saw the approval of [Imdelltra], a completely new type of therapy for [SCLC]. … Because of this advance, we’re going to see new clinical trials and new treatment options for small cell compared [with] the past. That pace has been a little slower, so I think we’ll continue to see clinical trials in that area.”
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