Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study

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Abstract

Background

Ipilimumab has shown long-term overall survival (OS) in patients with advanced melanoma in clinical trials, but robust real-world evidence is lacking. We present long-term outcomes from the IMAGE study (NCT01511913) in patients receiving ipilimumab and/or non-ipilimumab (any approved treatment other than ipilimumab) systemic therapies.

Methods

IMAGE was a multinational, prospective, observational study assessing adult patients with advanced melanoma treated with ipilimumab or non-ipilimumab systemic therapies between June 2012 and March 2015 with ≥3 years of follow-up. Adjusted OS curves based on multivariate Cox regression models included covariate effects. Safety and patient-reported outcomes were assessed.

Results

Among 1356 patients, 1094 (81%) received ipilimumab and 262 (19%) received non-ipilimumab index therapy (systemic therapy [chemotherapy, anti–programmed death 1 antibodies, or BRAF ± MEK inhibitors], radiotherapy, and radiosurgery). In the overall population, median age was 64 years, 60% were male, 78% were from Europe, and 78% had received previous treatment for advanced melanoma. In the ipilimumab-treated cohort, 780 (71%) patients did not receive subsequent therapy (IPI-noOther) and 314 (29%) received subsequent non-ipilimumab therapy (IPI-Other) on study. In the non-ipilimumab–treated cohort, 205 (78%) patients remained on or received other subsequent non-ipilimumab therapy (Other-Other) and 57 (22%) received subsequent ipilimumab therapy (Other-IPI) on study. Among 1151 patients who received ipilimumab at any time during the study (IPI-noOther, IPI-Other, and Other-IPI), 296 (26%) reported CTCAE grade ≥ 3 treatment-related adverse events, most occurring in year 1. Ipilimumab-treated and non-ipilimumab–treated patients who switched therapy (IPI-Other and Other-IPI) had longer OS than those who did not switch (IPI-noOther and Other-Other). Patients with prior therapy who did not switch therapy (IPI-noOther and Other-Other) showed similar OS. In treatment-naive patients, those in the IPI-noOther group tended to have longer OS than those in the Other-Other group. Patient-reported outcomes were similar between treatment cohorts.

Conclusions

With long-term follow-up (≥ 3 years), safety and OS in this real-world population of patients treated with ipilimumab 3 mg/kg were consistent with those reported in clinical trials. Patient-reported quality of life was maintained over the study period. OS analysis across both pretreated and treatment-naive patients suggested a beneficial role of ipilimumab early in treatment.

Trial registration

ClinicalTrials.gov, NCT01511913. Registered January 19, 2012 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01511913

Supplementary Information

The online version contains supplementary material available at 10.1186/s12885-021-08032-y.

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Most cited references 25

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Cancer statistics, 2019

Rebecca Siegel, Kimberly D Miller, Ahmedin Jemal (2019)

Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data on cancer incidence, mortality, and survival. Incidence data, available through 2015, were collected by the Surveillance, Epidemiology, and End Results Program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data, available through 2016, were collected by the National Center for Health Statistics. In 2019, 1,762,450 new cancer cases and 606,880 cancer deaths are projected to occur in the United States. Over the past decade of data, the cancer incidence rate (2006-2015) was stable in women and declined by approximately 2% per year in men, whereas the cancer death rate (2007-2016) declined annually by 1.4% and 1.8%, respectively. The overall cancer death rate dropped continuously from 1991 to 2016 by a total of 27%, translating into approximately 2,629,200 fewer cancer deaths than would have been expected if death rates had remained at their peak. Although the racial gap in cancer mortality is slowly narrowing, socioeconomic inequalities are widening, with the most notable gaps for the most preventable cancers. For example, compared with the most affluent counties, mortality rates in the poorest counties were 2-fold higher for cervical cancer and 40% higher for male lung and liver cancers during 2012-2016. Some states are home to both the wealthiest and the poorest counties, suggesting the opportunity for more equitable dissemination of effective cancer prevention, early detection, and treatment strategies. A broader application of existing cancer control knowledge with an emphasis on disadvantaged groups would undoubtedly accelerate progress against cancer.

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Improved Survival with Ipilimumab in Patients with Metastatic Melanoma

F. Stephen Hodi, Steven J O'Day, David F McDermott … (2010)

An improvement in overall survival among patients with metastatic melanoma has been an elusive goal. In this phase 3 study, ipilimumab--which blocks cytotoxic T-lymphocyte-associated antigen 4 to potentiate an antitumor T-cell response--administered with or without a glycoprotein 100 (gp100) peptide vaccine was compared with gp100 alone in patients with previously treated metastatic melanoma. A total of 676 HLA-A*0201-positive patients with unresectable stage III or IV melanoma, whose disease had progressed while they were receiving therapy for metastatic disease, were randomly assigned, in a 3:1:1 ratio, to receive ipilimumab plus gp100 (403 patients), ipilimumab alone (137), or gp100 alone (136). Ipilimumab, at a dose of 3 mg per kilogram of body weight, was administered with or without gp100 every 3 weeks for up to four treatments (induction). Eligible patients could receive reinduction therapy. The primary end point was overall survival. The median overall survival was 10.0 months among patients receiving ipilimumab plus gp100, as compared with 6.4 months among patients receiving gp100 alone (hazard ratio for death, 0.68; P<0.001). The median overall survival with ipilimumab alone was 10.1 months (hazard ratio for death in the comparison with gp100 alone, 0.66; P=0.003). No difference in overall survival was detected between the ipilimumab groups (hazard ratio with ipilimumab plus gp100, 1.04; P=0.76). Grade 3 or 4 immune-related adverse events occurred in 10 to 15% of patients treated with ipilimumab and in 3% treated with gp100 alone. There were 14 deaths related to the study drugs (2.1%), and 7 were associated with immune-related adverse events. Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma. Adverse events can be severe, long-lasting, or both, but most are reversible with appropriate treatment. (Funded by Medarex and Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00094653.)

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Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma

James Larkin, Vanna Chiarion-Sileni, Rene Gonzalez … (2019)

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Author and article information

Contributors

Stéphane Dalle: stephane.dalle@chu-lyon.fr

Journal

Journal ID (nlm-ta): BMC Cancer

Journal ID (iso-abbrev): BMC Cancer

Title: BMC Cancer

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2407

Publication date (Electronic): 29 May 2021

Publication date PMC-release: 29 May 2021

Publication date Collection: 2021

Volume: 21

Electronic Location Identifier: 642

Affiliations

[1 ]GRID grid.413852.9, ISNI 0000 0001 2163 3825, Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, ; 69495 Pierre-Bénite, France

[2 ]GRID grid.410463.4, ISNI 0000 0004 0471 8845, Université de Lille, INSERM U1189, CHRU Lille, ; 59037 Lille, France

[3 ]GRID grid.24029.3d, ISNI 0000 0004 0383 8386, Cambridge University Hospitals NHS Foundation Trust, ; Cambridge, CB0 2QQ UK

[4 ]GRID grid.17788.31, ISNI 0000 0001 2221 2926, Hadassah Hebrew University Hospital, ; 91120 Jerusalem, Israel

[5 ]GRID grid.416204.5, ISNI 0000 0004 0391 9602, Royal Preston Hospital, ; Preston, PR2 9HT UK

[6 ]GRID grid.410458.c, ISNI 0000 0000 9635 9413, Hospital Clínic Barcelona, ; 08036 Barcelona, Spain

[7 ]GRID grid.7708.8, ISNI 0000 0000 9428 7911, Department of Dermatology, Faculty of Medicine, , Medical Center – University of Freiburg, ; 79104 Freiburg, Germany

[8 ]GRID grid.4562.5, ISNI 0000 0001 0057 2672, University of Lübeck, ; 23538 Lübeck, Germany

[9 ]GRID grid.10423.34, ISNI 0000 0000 9529 9877, Medizinische Hochschule Hannover, ; 30625 Hanover, Germany

[10 ]GRID grid.492959.a, Syneos Health, ; Morrisville, NC 27560 USA

[11 ]GRID grid.419971.3, Bristol Myers Squibb, ; Princeton, NJ 08543 USA

[12 ]GRID grid.492824.1, Health Outcomes Solutions, ; Winter Park, FL 32790 USA

[13 ]GRID grid.415719.f, ISNI 0000 0004 0488 9484, Churchill Hospital, ; Oxford, OX3 7DQ UK

Article

Publisher ID: 8032

DOI: 10.1186/s12885-021-08032-y

PMC ID: 8164785

PubMed ID: 34051732

SO-VID: 1a83de84-48d8-40da-a28b-9637e588a0b3

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 20 November 2020

Date accepted : 15 March 2021

Funding

Funded by: This work was supported by Bristol Myers Squibb (no grant number is applicable).

Custom metadata

ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: advanced melanoma,ipilimumab,overall survival,quality of life,real-world,subsequent therapy

Data availability:

ScienceOpen disciplines: Oncology & Radiotherapy

Keywords: advanced melanoma, ipilimumab, overall survival, quality of life, real-world, subsequent therapy

Long-term real-world experience with ipilimumab and non-ipilimumab therapies in advanced melanoma: the IMAGE study

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Abstract

Background

Methods

Results

Conclusions

Trial registration

Supplementary Information

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Karger: Oncology

Most cited references 25

Cancer statistics, 2019

Improved Survival with Ipilimumab in Patients with Metastatic Melanoma

Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma

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