Drug updated on 9/4/2024
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.
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Summary
- Imdelltra (tarlatamab-dlle) is 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.
- This summary is based on the review of one randomized controlled trial(s). [1]
- The Objective Response Rate (ORR) was 40% (97.5% CI, 29 to 52) in the 10-mg dose group and 32% (97.5% CI, 21 to 44) in the 100-mg dose group among patients with previously treated small-cell lung cancer.
- Median Progression-Free Survival (PFS) was 4.9 months (95% CI, 2.9 to 6.7) for the 10-mg dose group and 3.9 months (95% CI, 2.6 to 4.4) for the 100-mg dose group, with overall survival at 9 months estimated at 68% for the 10-mg group and 66% for the 100-mg group.
- Duration of response was maintained for at least 6 months in 59% of patients who achieved an objective response, with 55% of responses ongoing in the 10-mg group and 57% in the 100-mg group at data cutoff.
- Cytokine-release syndrome (CRS) was observed in 51% of patients in the 10-mg group and 61% in the 100-mg group, with grade 3 CRS occurring in 1% and 6% of patients, respectively. Decreased appetite occurred in 29% of patients in the 10-mg group and 44% in the 100-mg group; pyrexia occurred in 35% and 33% of patients in the 10-mg and 100-mg groups, respectively. Only 3% of patients discontinued tarlatamab due to treatment-related adverse events.
- There is no population types or subgroups information 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 91320-1799 U.S.A. |
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