Drug updated on 6/12/2025
Dosage Form | Injection (intravenous; 20 mg or 100 mg powder for reconsitution in a single dose vial) |
Drug Class | c-Met-directed antibody and microtubule inhibitor conjugates |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy
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Summary
- This summary is based on the review of one randomized controlled trial. [1]
- Emrelis (telisotuzumab vedotin-tllv) is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with high mesenchymal-epithelial transition factor (c-Met) protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by a Food and Drug Administration (FDA)-approved test, who have received prior systemic therapy.
- In patients with nonsquamous epidermal growth factor receptor (EGFR)-wildtype NSCLC, the overall response rate (ORR) to telisotuzumab vedotin was 28.6% (95% confidence interval [CI], 21.7 to 36.2); ORR was 34.6% (95% CI, 24.2 to 46.2) in those with high c-Met overexpression and 22.9% (95% CI, 14.4 to 33.4) in those with intermediate c-Met overexpression.
- The median duration of response (DoR) was 8.3 months (95% CI, 5.6 to 11.3); with subgroup medians of 9.0 months (95% CI, 4.2 to 13.0) for high c-Met overexpression and 7.2 months (95% CI, 5.3 to 11.5) for intermediate c-Met overexpression. Median overall survival (OS) was 14.5 months (95% CI, 9.9 to 16.6); the high c-Met overexpression subgroup had a median OS of 14.6 months (95% CI, 9.2 to 25.6), and the intermediate subgroup had a median OS of 14.2 months (95% CI, 9.6 to 16.6).
- In patients with nonsquamous EGFR-wildtype NSCLC and c-Met protein-overexpressing tumors, the most common adverse events were peripheral sensory neuropathy (30%), peripheral edema (16%), and fatigue (14%).
- The most common grade ≥3 adverse event was peripheral sensory neuropathy, occurring in 7% of patients.
- In patients with nonsquamous EGFR-wildtype NSCLC and c-Met protein-overexpressing tumors (defined as high: ≥50% tumor cells with 3+ staining; intermediate: ≥25% but <50% with 3+ staining), subgroup analysis showed higher ORR in the high overexpression group (34.6%, 95% CI: 24.2–46.2) compared to the intermediate group (22.9%, 95% CI: 14.4–33.4); median DoR was 9.0 months (95% CI: 4.2–13.0) versus 7.2 months (95% CI: 5.3–11.5), respectively.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Emrelis (telisotuzumab vedotin-tllv) Prescribing Information | 2025 | AbbVie Inc., North Chicago, IL |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Telisotuzumab Vedotin Monotherapy in Patients With Previously Treated c-Met Protein-Overexpressing Advanced Nonsquamous EGFR-Wildtype Non-Small Cell Lung Cancer in the Phase II LUMINOSITY Trial | 161Subjects F: 31% M: 69% | 2024 | Journal of Clinical Oncology |
Sex Distribution:
F:31%
M:69%
161Subjects
Year:
2024
Source:Journal of Clinical Oncology