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High-dose interleukin-2 was the first immunotherapy to cure a small fraction of patients with metastatic melanoma and kidney cancer, at the cost of ICU-level toxicity; today it mainly supports TIL therapy.
Approved 1992 (RCC) and 1998 (melanoma) on ~15% response with ~5-7% durable complete responses (Rosenberg). Capillary leak, hypotension and multi-organ effects confine it to specialised centres. Now used as a short course after lifileucel (TIL) infusion; engineered IL-2 variants (bempegaldesleukin) failed in phase 3.
Backbone ribbon from PDB 1M47. RCSB PDB 1M47. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
Activates IL-2 receptors on T and NK cells, driving proliferation and cytotoxicity; high doses cause capillary leak.
1.Aldesleukin (high-dose IL-2) binds its target.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. High-dose IL-2 is given as an inpatient course, so hospital stays fall under Part A.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE search: aldesleukin (high-dose IL-2). Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| US | 1992 | Metastatic renal cell carcinoma |
| US | 1998 | Metastatic melanoma |
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This trial supplied the randomised proof that was missing for TIL therapy and showed academic centres can run cell-therapy phase 3 trials without industry. It supports TIL as a standard option after checkpoint inhibitor failure in melanoma and underpinned reimbursement in the Netherlands. The comparator, ipilimumab, is itself only modestly effective in this setting, and overall survival did not differ significantly.
Lifileucel proved that Steven Rosenberg's decades-old TIL concept could be industrialised into a licensed product and gave patients with checkpoint-refractory melanoma, who otherwise have few options, a chance of durable remission. It is the first cell therapy approved for any solid tumour. The treatment requires surgery to harvest tumour, hospitalisation for lymphodepletion and IL-2, and specialised centres, so its reach is limited.
This is the trial behind the 2008 European authorisation of Ceplene, one of very few maintenance immunotherapies ever approved in acute myeloid leukaemia. The abstract reports no overall survival benefit and the drug is little used today, with oral azacitidine and targeted maintenance filling the space.
Query for this drug: (TITLE:"Aldesleukin" OR ABSTRACT:"Aldesleukin" OR TITLE:"high-dose IL-2" OR ABSTRACT:"high-dose IL-2" OR TITLE:"Proleukin" OR ABSTRACT:"Proleukin" OR TITLE:"Interleukin-2" OR ABSTRACT:"Interleukin-2" OR TITLE:"IL-2" OR ABSTRACT:"IL-2" OR TITLE:"Recombinant interleukin-2" OR ABSTRACT:"Recombinant interleukin-2") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Aldesleukin (high-dose IL-2), not a curated reading list.
Shares Cytokines & engineered cytokines, Renal cell carcinoma, Melanoma and the tag historic.
Shares Iovance Biotherapeutics, C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, TIL therapy, Advanced melanoma (unresectable stage III and stage IV).
Shares C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, NCI Center for Cancer Research (intramural programme), TIL therapy, Cytokines & engineered cytokines.
Shares Iovance Biotherapeutics, TIL therapy, Advanced melanoma (unresectable stage III and stage IV), Melanoma.
Shares Iovance Biotherapeutics, Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma, C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed, TIL therapy.
Shares Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma, TIL therapy, Advanced melanoma (unresectable stage III and stage IV), Melanoma.
Shares Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients, TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer, Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers, Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer.
Shares Iovance Biotherapeutics, Advanced melanoma (unresectable stage III and stage IV), Melanoma.