# Aldesleukin (high-dose IL-2)

Source: https://onco.cc/drugs/aldesleukin/  
OnCo record `aldesleukin` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Also known as: Interleukin-2; IL-2; Recombinant interleukin-2
- Tags: gap-fill; historic
- Brand: Proleukin
- Modality: Recombinant interleukin-2 (cytokine)
- Mechanism: Activates IL-2 receptors on T and NK cells, driving proliferation and cytotoxicity; high doses cause capillary leak.
- Approvals: US 1992: Metastatic renal cell carcinoma; US 1998: Metastatic melanoma

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Aldesleukin
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=aldesleukin

## Connected records

- cancers: [Advanced melanoma (unresectable stage III and stage IV)](https://onco.cc/cancers/advanced-melanoma/), [High-risk neuroblastoma](https://onco.cc/cancers/neuroblastoma-high-risk/), [Melanoma](https://onco.cc/cancers/melanoma/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/)
- technologies: [Cytokines & engineered cytokines](https://onco.cc/technologies/cytokine-therapy/), [TIL therapy](https://onco.cc/technologies/til-therapy/)
- companies: [Iovance Biotherapeutics](https://onco.cc/companies/iovance/)
- trials: [A Modular, Phase I/II, Multicentre Study to Evaluate AZD4045, in Participants With Relapsed or Refractory Multiple Myeloma](https://onco.cc/trials/nct07681596/), [Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers](https://onco.cc/trials/nct02830724/), [Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients](https://onco.cc/trials/nct03190941/), [Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers](https://onco.cc/trials/nct05296564/), [Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer](https://onco.cc/trials/nct06530303/), [Histamine Dihydrochloride and Interleukin-2 in Primary Resectable Pancreatic Cancer](https://onco.cc/trials/nct05810792/), [IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers](https://onco.cc/trials/nct06119685/), [Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer](https://onco.cc/trials/nct01174121/), [Study 0201](https://onco.cc/trials/study-0201/), [Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Ca](https://onco.cc/trials/nct05267626/), [Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma](https://onco.cc/trials/nct01700946/), [TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer](https://onco.cc/trials/nct06532812/)
- people: [Sharon Belvin](https://onco.cc/people/sharon-belvin/)
- key papers: [C-144-01: lifileucel, tumour-infiltrating lymphocytes grown from a patient's own tumour, in melanoma after checkpoint inhibitors have failed](https://onco.cc/key-papers/paper-c-144-01-lifileucel-melanoma-jco-2021/), [Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial](https://onco.cc/key-papers/paper-study-0201-blood-2006/), [Rohaas 2022: the first randomised trial of TIL therapy, against ipilimumab, in advanced melanoma](https://onco.cc/key-papers/paper-rohaas-til-vs-ipilimumab-nejm-2022/)
- terms: [Cytokine](https://onco.cc/terms/cytokine/)
- institutions: [NCI Center for Cancer Research (intramural programme)](https://onco.cc/institutions/nci-ccr/)
- drugs: [Histamine dihydrochloride](https://onco.cc/drugs/histamine-dihydrochloride/)

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