Originally published by our sister publication Clinical Oncology News
By Clinical Oncology News Staff
The FDA has granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
Efficacy was evaluated in 99 patients with relapsed/refractory ES-SCLC with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 (ClinicalTrials.gov. Identifier: NCT05060016), an open-label, multicenter, multi-cohort study. Patients with symptomatic brain metastases, interstitial lung disease or noninfectious pneumonitis, and active immunodeficiency were excluded. Patients received tarlatamab-dlle until disease progression or unacceptable toxicity.
The major efficacy outcome measures were overall response rate (ORR) per RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 and duration of response (DOR), as assessed by blinded independent central review. The ORR was 40% (95% CI, 31%-51%) and median DOR was 9.7 months (range, 2.7-20.7+ months). Of the 69 patients with available data regarding platinum sensitivity status, the ORR was 52% (95% CI, 32%-71%) in 27 patients with platinum-resistant SCLC (defined as progression <90 days after last dose of platinum therapy) and 31% (95% CI, 18%-47%) in 42 patients with platinum-sensitive SCLC (defined as progression ≥90 days after last dose of platinum therapy).
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.
The full prescribing information for tarlatamab-dlle is posted here.
Based on a press release from the FDA.
