Tarlatamab, an immunotherapy drug, was shown to improve objective response rate (percentage of patients whose disease shrunk or disappeared) and overall survival (time from treatment until death of any cause) outcomes when given to patients with small-cell lung cancer in a 10-mg dose every two weeks, according to findings published in the New England Journal of Medicine.
Previously, a phase 1 trial tested outcomes of tarlatamab in patients with previously treated small-cell lung cancer. The drug showed successful activity, targeting delta-like ligand 3 and CD3, and had promising antitumor activity in this population.
The phase 2 DeLLphi-301 study, compiled of 222 patients, evaluated the antitumor activity within given patient population. The study also focused on the efficiency, safety side-effect profile and pharmacokinetics of the drug in patients with small-cell lung cancer.
The study was broken up into three parts: Part one was a dose comparison within 180 patients in the study, where patients received either 10 mg of tarlatamab or 100 mg within a 60-minute infusion. Part two focused on the patient population that been enrolled in the selected dose. Part three focused on the efficiency and safety of the overall drug within the patient population.
Patients within the study had to be at least 18, with a confirmed diagnosis of relapsed/ refractory small-cell lung cancer with at least one line of therapy.
The primary endpoint of the study was to identify the overall objective response (representing the efficiency of the drug to the disease). Secondary endpoints of the study were: duration of objective response, disease control, progression-free survival (the time from randomization/initiation of treatment to the occurrence of disease progression or death), overall survival, side effects and within the treatment serum concentration of the drug and antibody within the drug.
A total of 176 patients were randomly assigned to receive a 10 mg dose of tarlatamab (88 patients) or 100 mg (88 patients). The 10 mg dose showed better outcomes, and was the dose used into part two and three. The median duration of treatment for tarlatamab was 5.1 months in the 10 mg group and 3.7 months in the 100 mg dose. The median follow up was 10.6 months in the 10 mg dose and 10.3 months in the 100 mg dose.
Sixty-eight patients responded to therapy, with a duration of six months in 40 patients and nine months in 20 patients. Median progression-free survival was 4.9 months in the 10 mg dose and 3.9 months in the 100 mg dose. Six- and nine-month overall survival rates were 40% and 28% within the 10 mg dose groups and 73% and 68% in the 100 mg dose group.
Within the study, the 10 mg dose of tatlatamab given every two weeks resulted in a successful objective response and improved survival outcomes in patients with small-cell lung cancer.
Treatment-related side effects within the study included: cytokine-release syndrome (51% in 10 mg dose and 61% in 100 mg dose), decreased appetite (29% in the 10mg dose and 44% in the 100mg dose), pyrexia (35% in the 10mg dose and 33% in the 100mg dose) and anemia (26% in the 10mg dose and 25% in the 100mg dose).
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