FDA Grants Accelerated Approval to Tarlatamab for Patients With Extensive-Stage Small Cell Lung Cancer

On May 16, 2024, the US Food and Drug Administration (FDA) granted accelerated approval to tarlatamab for patients with extensive-stage small cell lung cancer (SCLC) who experienced disease progression on or after platinum-based chemotherapy. This regulatory decision was based on results from the phase 2 DeLLphi-301 study.

This open-label, multi-cohort study enrolled 99 patients with relapsed or refractory extensive-stage SCLC who had experienced disease progression on or after platinum-based chemotherapy. Patients received 1 mg of intravenous tarlatamab on cycle 1 day 1, followed by 10 mg on cycle 1 days 8 and 15, and an additional 10 mg every 2 weeks thereafter, until disease progression or unacceptable toxicity. Patients were excluded on the basis of symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency. The major efficacy outcomes included overall response rate (ORR), and duration of response (DOR) in both the intention-to-treat population and in patients with platinum sensitivity (n = 69; platinum-resistant, n = 27; platinum sensitive, n = 42).

At analysis, the ORR in the intention-to-treat population was 40% and median DOR was 9.7 months. ORR was 52% among patients with platinum-resistant disease and 31% among patients with platinum-sensitive disease. The most common adverse reactions occurring in >20% of patients included cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia, and nausea. The most common grade 3/4 laboratory abnormalities occurring in ≥5% of patients included decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium.

The recommended dose of tarlatamab is 1 mg intravenously on cycle 1 day 1, followed by 10 mg on cycle 1 days 8 and 15, followed by an additional 10 mg every 2 weeks thereafter until disease progression or unacceptable toxicity. The prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome

Source:

FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer. Published online: May 16, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer