Drug updated on 10/18/2024
Dosage Form | Injection (intravenous; 1 mg, 10 mg) |
Drug Class | Bispecific 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Imdelltra (tarlatamab-dlle) Prescribing Information. | 2024 | Amgen Inc., One Amgen Center Drive Thousand Oaks, CA |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer | 222Subjects F: 29% M: 71% | 2023 | The New England Journal of Medicine |
Sex Distribution:
F:29%
M:71%
222Subjects
Year:
2023
Source:The New England Journal of Medicine