In May, 2024, the Food and Drug Administration granted accelerated approval to Imdelltra (tarlatamab-dlle) for the treatment of extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Recent Imdelltra data presented at the 2024 World Conference on Lung Cancer Conference demonstrates:
- Sustained efficacy and safety of Imdelltra in long-term follow-up data from the study that led to its FDA approval in ES-SCLC, and
- Potential in first-line maintenance therapy in combination with a PD-L1 inhibitor for ES-SCLC in a phase 1b study
About Imdelltra
Imdelltra is a first-in-class bispecific T-cell engager (BiTE) that targets a Delta-like ligand 3 (DLL3) that activates a patients own T cells to attack DLL3-expressing tumor cells. Bispecifics represent an innovative immunotherapy approach that help the body’s immune system target cancer cells. Bispecific antibodies or BiTE which is short for “bispecific T cell engager” are antibodies with two arms. One arm of the drug attaches to a specific protein on the cancer cell. The other arm of the BiTE activates immune cells in the patient to kill the cancer cells.
DeLLphi-301 Study
The FDA approval of Imdelltra was based on a phase 2 study, called the DeLLphi-301, in patients with relapsed/refractory ES-SCLC who experienced disease progression following platinum-based chemotherapy. Patients with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded. Patients received Imdelltra until disease progression or unacceptable toxicity.
Extended follow-up results from the DeLLphi-301 study show that Imdelltra continues to be effective and generally well-tolerated in patients with extensive-stage small cell lung cancer who had previously received platinum-based chemotherapy.
Here’s what the updated results tell us:
- Effectiveness:
- 40% of patients saw their tumors shrink or disappear (called an objective response).
- About half of those who responded were still benefiting from the treatment when the study data was analyzed.
- 30% of patients had their disease stabilize.
- On average, patients’ cancer was controlled for about 7 months.
- Patients lived for a median of 15.2 months after starting treatment.
- Safety:
- The treatment continued to be manageable over time, with no new unexpected side effects appearing.
- This suggests that Imdelltra can be used safely for longer periods.
- Consistent benefit:
- The treatment seemed to work equally well for patients whose cancer had quickly returned after initial chemotherapy and those whose cancer took longer to come back.
These results are encouraging because they show that Imdelltra can offer lasting benefits to patients with this difficult-to-treat type of lung cancer, regardless of how quickly their cancer had progressed after initial treatment. Patients with ES-SCLC should discuss with their oncologists whether they might be a candidate for treatment with Imdelltra.
The prescribing information for Imdelltra includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). The most common side effects are cytokine release syndrome (CRS), fatigue, fever, decreased appetite, musculoskeletal pain, constipation, anemia and nausea.
Investigational Use in First-Line Maintenance Therapy
In the DeLLphi-303 phase 1b study, Imdelltra combined with a PD-L1 inhibitor as first-line maintenance therapy in ES-SCLC demonstrated a manageable safety profile with sustained disease control and positive survival outcomes. More research is needed to fully understand the benefits and risks of this approach. Patients with newly diagnosed ES-SCLC should discuss with their oncologists the risks and benefits of available treatment options as well as clinical trial approaches.
More Reading
Newly Diagnosed With Lung Cancer? What Every Patient Should Know
The Importance of Molecular Testing
Precision Medicines & Immunotherapy
Must Read Tips for Beating Lung Cancer
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Reference:
Sands J, Cho BC, Ahn M-J, et al. Tarlatamab Sustained Clinical Benefit and Safety in Previously Treated SCLC: DeLLphi-301 Phase 2 Extended Follow-up. Abstract OA10.03. Presented at the 2024 World Conference on Lung Cancer. September 7-10, 2024. San Diego, CA.
Lau S, Ahn M-J, Moskovitz M, et al. Tarlatamab with a PD-L1 inhibitor as first-line maintenance after chemo-immunotherapy for ES-SCLC. Abstract OA10.04. Presented at the 2024 World Conference on Lung Cancer. September 7-10, 2024. San Diego, CA.
