Journal article
An Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
Oncoimmunology, Vol.10(1), pp.1984059-1984059
01/01/2021
DOI: 10.1080/2162402X.2021.1984059
PMCID: PMC8510610
PMID: 34650833
Abstract
Combination immunotherapy with sequential administration may enhance metastatic melanoma (MM) patients with long-term disease control. High Dose Aldesleukin/Recombinant Interleukin-2 (HD rIL-2) and ipilimumab (IPI) offer complementary mechanisms against MM. This phase IV study assessed the sequenced use of HD rIL-2 and IPI in MM patients. Eligible Stage IV MM patients were randomized to treatment with either two courses of HD rIL-2(600,000 IU/kg) followed by four doses of IPI 3 mg/kg or vice-versa. The primary objective was to compare one-year overall survival (OS) with historical control (46%, Hodi et al., NEJM 2010). Secondary objectives were 1-year progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs) profile. Evaluable Population (EP) included patients who received at least 50% of planned treatment with each drug. Thirteen and 16 patients were randomized to receive HD rIL-2 first, and IPI first, respectively. One-year OS rate was 75% for intention to treat population. Eighteen patients were included in EP, 8 in HD rIL-2, 10 in IPI first arm. In EP, 1-year OS, PFS and ORR rates were 87%, 68%, and 50%, respectively. The frequency of AEs was similar in both arms with 13 patients experiencing Grade 3 or higher AEs, 3 resulting in the end of study participation. There was one HD rIL-2-related death, from cerebral hemorrhage due to thrombocytopenia. In this study with small sample size, HD rIL-2 and IPI were safe to administer sequentially in MM patients and showed more than additive effects. 1-year OS was superior to that of IPI alone from historical studies.
Details
- Title: Subtitle
- An Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients with Metastatic Melanoma
- Creators
- Merve Hasanov - The University of Texas MD Anderson Cancer CenterDenái R. Milton - The University of Texas MD Anderson Cancer CenterWilliam H. Sharfman - Sidney Kimmel Comprehensive Cancer CenterBret Taback - Columbia University Irving Medical CenterLee D. Cranmer - University of Washington Medical CenterGregory A Daniels - University of California, San DiegoLawrence Flaherty - The Barbara Ann Karmanos Cancer InstituteSigrun Hallmeyer - Summit Medical GroupMohammed Milhem - University of Iowa Hospitals and ClinicsLynn Feun - University of Miami Health SystemRalph Hauke - Nebraska Cancer SpecialistsGary Doolittle - University of Kansas Medical CenterNancy Gregory - Clinigen Group, Yardley, USA.Sapna Patel - The University of Texas MD Anderson Cancer Center
- Resource Type
- Journal article
- Publication Details
- Oncoimmunology, Vol.10(1), pp.1984059-1984059
- Publisher
- Taylor & Francis
- DOI
- 10.1080/2162402X.2021.1984059
- PMID
- 34650833
- PMCID
- PMC8510610
- ISSN
- 2162-4011
- eISSN
- 2162-402X
- Grant note
- DOI: 10.13039/100008953, name: Prometheus; name: Clinigen
- Language
- English
- Date published
- 01/01/2021
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359589702771
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