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Lifileucel plus Pembrolizumab
Lifileucel is an autologous tumor-infiltrating lymphocyte (TIL) therapy that expands patient-derived T cells from their tumor and reinfuses them alongside pembrolizumab, a PD-1 inhibitor, to enhance anti-tumor immune response.
Lifileucel is an autologous tumor-infiltrating lymphocyte (TIL) therapy that expands patient-derived T cells from their tumor and reinfuses them alongside pembrolizumab, a PD-1 inhibitor, to enhance anti-tumor immune response. Used for Metastatic melanoma (Phase 3 development).
At a glance
| Generic name | Lifileucel plus Pembrolizumab |
|---|---|
| Also known as | LN-144, Pembrolizumab |
| Sponsor | Iovance Biotherapeutics, Inc. |
| Drug class | Autologous cell therapy combined with PD-1 inhibitor |
| Target | PD-1 (pembrolizumab component); tumor-associated antigens (lifileucel component) |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lifileucel involves isolating tumor-infiltrating lymphocytes from a patient's own tumor, expanding them ex vivo to large numbers, and reinfusing them back into the patient. Pembrolizumab, a PD-1 checkpoint inhibitor, is administered concurrently to block PD-1/PD-L1 interactions and further enhance T-cell activation and persistence. Together, this combination aims to maximize tumor-specific T-cell recognition and killing of cancer cells.
Approved indications
- Metastatic melanoma (Phase 3 development)
Common side effects
- Cytokine release syndrome
- Immune-related adverse events (from pembrolizumab)
- Infusion reactions
- Fatigue
- Fever
Key clinical trials
- SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (PHASE3)
- Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients (PHASE1)
- Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma. (PHASE3)
- Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors (PHASE2)
- Efficacy & Safety for LN144 With Pembrolizumab With High Risk Stage IIIb-dResectable Melanoma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lifileucel plus Pembrolizumab CI brief — competitive landscape report
- Lifileucel plus Pembrolizumab updates RSS · CI watch RSS
- Iovance Biotherapeutics, Inc. portfolio CI