The drug achieved a 40% response rate in clinical trials for extensive-stage small cell lung cancer with progression after chemotherapy.
RT’s Three Key Takeaways:
- Tarlatamab-dlle (Imdelltra, Amgen, Inc) has received accelerated approval from the FDA for the treatment of extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
- In clinical trials, tarlatamab-dlle demonstrated a 40% objective response rate and a median duration of response of 9.7 months in patients with relapsed/refractory extensive-stage small cell lung cancer.
- Continued approval for tarlatamab-dlle may be contingent upon verification and description of clinical benefit in a confirmatory trial, with the drug showing promising initial results in extending overall survival.
The Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc) for extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
Tarlatamab-dlle received accelerated approval based on overall response rate and duration of response observed in clinical studies. Continued approval may be contingent upon verification of clinical benefit.
Clinical Trial Results
Efficacy was evaluated in 99 patients with relapsed/refractory extensive stage small cell lung cancer with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301, an open-label, multicenter, multi-cohort study. Patients with symptomatic brain metastases, interstitial lung disease, or non-infectious pneumonitis, and active immunodeficiency were excluded. Patients received tarlatamab until disease progression or unacceptable toxicity.
The clinical trial evaluated tarlatamab-dlle in patients with small cell lung cancer who had failed two or more prior lines of treatment and who had received the 10 mg every two weeks dosing regimen. Results from the study found that tarlatamab-dlle at the 10 mg two weeks dosing regiment (N=99) demonstrated a robust objective response rate of 40% (95% Confidence Interval [CI]: 31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median overall survival was 14.3 months, with final and complete survival data yet to mature.
“Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC (extensive stage small cell lung cancer) live longer than five years,” says David P. Carbone, MD, PhD, professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center, in a release. “In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm.”
Safety and Adverse Reactions
The prescribing information for tarlatamab-dlle includes a Boxed Warning for serious or life-threatening cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. The most common adverse reactions (>20%) were cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia, and nausea.
The most common Grade 3 or 4 laboratory abnormalities (≥5%) were decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium.
Dosage and Designations
The recommended tarlatamab dose is an initial dose of 1 mg administered as an intravenous infusion over one hour on Cycle 1 Day 1, followed by 10 mg on Cycle 1 Day 8 and Day 15 then every two weeks thereafter until disease progression or unacceptable toxicity.
This application was granted priority review, breakthrough designation, and orphan drug designation.
