FDA Grants Accelerated Approval to Tarlatamab-dlle for Extensive Stage SCLC 

The Food and Drug Administration (FDA) has granted accelerated approval to tarlatamab-dlle (Imdelltra) for patients with extensive stage small cell lung cancer (ES-SCLC) who have disease progression on or after platinum-based chemotherapy.

The treatment “is the first-and-only bispecific T-cell engager therapy for advanced SCLC,” according to Amgen, the manufacturer of the drug.

The efficacy of the treatment was evaluated in DeLLphi-301, an open-label, multicenter, multicohort study that included 99 patients who had relapsed or refractory ES-SCLC with disease progression after platinum-based chemotherapy. The patients received tarlatamab-dlle until disease progression or unacceptable toxicity.

The major efficacy outcome measures were the overall response rate (ORR) and duration of response (DOR), as assessed by blinded independent central review. The ORR was 40%, with a median DOR of 9.7 months. Among the 69 patients who had available data regarding platinum sensitivity status, the ORR was 52% in 27 patients with platinum-resistant SCLC and 31% in 42 patients with platinum-sensitive SCLC.

The most common adverse reactions were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia, and nausea.

The most common grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium.

The prescribing information for tarlatamab-dlle includes a boxed warning for serious or life-threatening CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.

The recommended dose is an initial dose of tarlatamab-dlle 1 mg administered as an intravenous infusion over 1 hour on day 1 of cycle 1, followed by 10 mg on days 8 and 15 of cycle 1, then every 2 weeks thereafter until disease progression or unacceptable toxicity.

The full prescribing information for tarlatamab-dlle will be posted here.

Source: FDA