Tarlatamab-dlle

(Imdelltra®)

Imdelltra®

Drug updated on 10/17/2024

Dosage FormInjection (intravenous; 1 mg, 10 mg)
Drug ClassBispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engagers
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.

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Summary
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  • This summary is based on the review of one randomized controlled trial(s). [1]
  • In the 10-mg group, the objective response rate was 40% (97.5% CI (Confidence Interval), 29 to 52), with 59% of responders maintaining a response for at least 6 months and 55% of these responses ongoing. The 100-mg group had a 32% response rate (97.5% CI, 21 to 44), with 59% maintaining a response for at least 6 months and 57% ongoing.
  • Median progression-free survival (PFS) was 4.9 months (95% CI, 2.9 to 6.7) for the 10-mg group and 3.9 months (95% CI, 2.6 to 4.4) for the 100-mg group. Overall survival (OS) estimates at 9 months were 68% for the 10-mg group and 66% for the 100-mg group.
  • There were no significant population or subgroup differences reported in terms of effectiveness.
  • Cytokine-release syndrome (CRS) occurred in 51% of patients in the 10-mg group and 61% in the 100-mg group, with most cases being grade 1 or 2. Grade 3 CRS was reported in 1% of the 10-mg group and 6% of the 100-mg group.
  • Other common adverse events included decreased appetite (29% in the 10-mg group, 44% in the 100-mg group) and pyrexia (35% in the 10-mg group, 33% in the 100-mg group).
  • No population types or subgroups information was available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Imdelltra (tarlatamab-dlle) Prescribing Information.2024Amgen Inc., One Amgen Center Drive Thousand Oaks, CA

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer
222Subjects
F: 29%
M: 71%
2023The New England Journal of Medicine

Sex Distribution:

F:29%
M:71%
222Subjects

Year:

2023

Source:The New England Journal of Medicine