FDA approves Imdelltra for small cell lung cancer
Click Here to Manage Email Alerts
The FDA granted accelerated approval to tarlatamab-dlle for treatment of certain patients with extensive-stage small cell lung cancer.
The indication applies to use of the agent by patients whose disease progressed on or after platinum-based chemotherapy.
Tarlatamab-dlle (Imdelltra, Amgen) is a bispecific T-cell engager that binds to DLL3 on tumor cells and CD3 on T cells.
The FDA based approval on results of the DeLLphi-301 study, which included 99 patients with relapsed or refractory extensive-stage small cell lung cancer whose disease progressed after platinum-based chemotherapy.
Study criteria excluded patients with symptomatic brain metastases, interstitial lung disease or noninfectious pneumonitis, and active immunodeficiency.
Patients received tarlatamab-dlle until disease progression or unacceptable toxicity.
Overall response rate and duration of response served as major efficacy outcomes.
Results showed an ORR of 40% (95% CI, 31-51) and a median response duration of 9.7 months (range, 2.7-20.7+).
Sixty-nine patients had data about platinum sensitivity status. In this group, researchers reported ORRs of 52% (95% CI, 32-71) among the 27 patients with platinum-resistant small cell lung cancer and 31% (95% CI, 18-47) among the 42 patients with platinum-sensitive disease.
The most common adverse reactions among patients who received tarlatamab-dlle included cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia and nausea. The most common grade 3 to grade 4 laboratory abnormalities included 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 cytokine release syndrome and neurologic toxicity, according to an FDA press release.
Read more about
Click Here to Manage Email Alerts