Drug updated on 10/1/2024
| Dosage Form | Suspension (intravenous; 7.5 x 109 to 72 x 109 viable cells) |
| Drug Class | Antineoplastics |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor
Latest News
Summary
- This summary is based on the review of one randomized controlled trial(s).
- The investigator-assessed objective response rate (ORR) was 36% in 66 patients who had progressed after immune checkpoint inhibitors (ICI) and targeted therapy. The IRC-assessed ORR was 31.4% (95% CI: 24.1% to 39.4%) in 153 patients, with 8 complete responses and 40 partial responses. [1]
- The median duration of response was not reached at a median study follow-up of 27.6 months, with 41.7% of responses maintained for ≥18 months.
- Median overall survival (OS) was 13.9 months, and median progression-free survival (PFS) was 4.1 months.
- Common Grade 3/4 treatment-emergent adverse events (TEAEs) included thrombocytopenia (76.9%), anemia (50.0%), and febrile neutropenia (41.7%).
- No specific safety concerns beyond the common Grade 3/4 TEAEs were highlighted.
- The patient population consisted of heavily pretreated individuals with advanced melanoma, having progressed after immune checkpoint inhibitors and targeted therapies, with 81.7% having received both anti-PD-1 and anti-CTLA-4 therapies. Elevated LDH and larger target lesion diameters were associated with lower objective response rates, while patients with normal LDH and smaller target lesions showed better response outcomes. There is no additional population or subgroup information available beyond the baseline disease characteristics and pre-treatment history.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Amtagvi (lifileucel) Prescribing Information. | 2024 | Iovance Biotherapeutics, Inc., Philadelphia, PA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study | 153Subjects F: 70% M: 83% | 2022 | Journal for Immunotherapy of Cancer |
Sex Distribution:
F:70%
M:83%
153Subjects
Year:
2022
Source:Journal for Immunotherapy of Cancer