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

• Published in: BMC cancer Vol. 21; no. 1; pp. 1 - 12
• Main Authors: Dalle, Stéphane, Mortier, Laurent, Corrie, Pippa, Lotem, Michal, Board, Ruth, Arance, Ana María, Meiss, Frank, Terheyden, Patrick, Gutzmer, Ralf, Buysse, Brian, Oh, Kelly, Brokaw, Jane, Le, T. Kim, Mathias, Susan D., Scotto, Julie, Lord-Bessen, Jennifer, Moshyk, Andriy, Kotapati, Srividya, Middleton, Mark R.
• Format: Journal Article
• Language: English
• Published: London BioMed Central 29.05.2021; BioMed Central Ltd; BMC
• Subjects: Advanced melanoma; Adverse events; Antibodies; Biomedical and Life Sciences; Biomedicine; Cancer; Cancer Research; Cancer therapies; Care and treatment; Chemotherapy; Clinical trials; Consent; Enrollments; Experimental therapeutics and drug development; Health Promotion and Disease Prevention; Immunotherapy; Ipilimumab; Life Sciences; Medicine/Public Health; MEK inhibitors; Melanoma; Monoclonal antibodies; Oncology; Overall survival; Patient outcomes; Patients; PD-1 protein; Quality of life; Questionnaires; Radiation therapy; Radiosurgery; Radiotherapy; Real-world; Regression analysis; Research Article; Subsequent therapy; Surgical Oncology; Targeted cancer therapy; France; United States > US; Subsequent therapy; Advanced melanoma; Overall survival; Ipilimumab; Real-world; Quality of life
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-021-08032-y

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