4543 - Long-term real-world (RW) outcomes in patients with advanced melanoma (MEL) treated with ipilimumab (IPI) and non-IPI therapies: IMAGE study

Background

IPI has shown durable overall survival (OS) in patients (pts) with MEL in clinical trials, but robust RW evidence is lacking. We present long-term RW outcomes from the IMAGE study (NCT01511913) in which pts received IPI and non-IPI therapies.

Methods

IMAGE was a large, multinational, prospective, observational study that enrolled adult pts with MEL treated with IPI or non-IPI from June 2012 to March 2015 and included > 3 years of follow-up. Adjusted OS curves were based on multivariate Cox regression models by adjusting for covariate effects. Progression-free survival (PFS) was analyzed using Kaplan-Meier methods. Patients self-administered the EORTC QLQ-C30, a validated, cancer-specific, health-related quality of life (QoL) questionnaire.

Results

Of 1356 pts, 1094 (81%) received IPI and 262 (19%) received non-IPI as index therapy. In all pts, median age was 64 years, 60% were male, 78% were from the EU, median time on study was 6 months, and 78% were pretreated (received ≥ 2 lines of therapy). In the IPI cohort, 780 pts (71%) remained on IPI and 314 (29%) switched to non-IPI. In the non-IPI cohort, 205 pts (78%) remained on non-IPI and 57 (22%) switched to IPI. Among 1151 pts who received IPI, 26% reported grade ≥ 3 treatment-related adverse events (AEs); most AEs occurred during year 1. The 3-year OS rates were 28% in the IPI and 25% in the non-IPI cohorts. In pretreated pts, OS rates were 25% in the IPI and 23% in the non-IPI cohorts. However, in treatment-naive pts, the OS rate in the IPI cohort was 40% compared with 33% in the non-IPI cohort, although the small sample size limits interpretation. Median PFS was 3 months in both the IPI and non-IPI cohorts. Completion rates for EORTC QLQ-C30 Global Health Status (GHS) score were 58%–80%. No major differences were observed in changes from baseline for EORTC QLQ-C30 GHS scores between the IPI and non-IPI cohorts, with similar trends of initial worsening and subsequent improvement.

Conclusions

Long-term, RW outcomes from IMAGE were consistent with those from IPI clinical trials. OS analysis across treatment-naive and pretreated pts suggested a beneficial role of IPI early in the disease with no detrimental impact on QoL.

Clinical trial identification

NCT01511913.

Editorial acknowledgement

Kakoli Parai, PhD, and Andrea Lockett at StemScientific, an Ashfield Company, funded by Bristol-Myers Squibb.

Legal entity responsible for the study

Bristol-Myers Squibb.

Funding

Bristol-Myers Squibb.

Disclosure

S. Dalle: Advisory / Consultancy, Research grant / Funding (self): Bristol-Myers Squibb; Research grant / Funding (self): Merck, Sharp & Dohme. L. Mortier: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: GlaxoSmithKline; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Novartis; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: LEO Pharma; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Merck, Sharp & Dohme. P. Corrie: Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Merck, Sharp & Dohme; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: Incyte. R. Board: Honoraria (self), Advisory / Consultancy: Merck, Sharp & Dohme; Honoraria (self), Advisory / Consultancy: Bristol-Myers Squibb; Honoraria (self), Advisory / Consultancy: Pierre Fabre. A.M. Arance: Travel / Accommodation / Expenses: Bristol-Myers Squibb; Travel / Accommodation / Expenses: Merck, Sharp & Dohme; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: Merck. F. Meiss: Honoraria (self), Non-remunerated activity/ies: Bristol-Myers Squibb. P. Terheyden: Research grant / Funding (self): Bristol-Myers Squibb. R. Gutzmer: Research grant / Funding (institution): Bristol-Myers Squibb. J. Brokaw: Full / Part-time employment: Bristol-Myers Squibb. T.K. Le: Full / Part-time employment: Bristol-Myers Squibb. J. Scotto: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. J. Lord-Bessen: Full / Part-time employment: Bristol-Myers Squibb. A. Moshyk: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. S. Kotapati: Shareholder / Stockholder / Stock options, Full / Part-time employment: Bristol-Myers Squibb. M.R. Middleton: Advisory / Consultancy: Amgen, GlaxoSmithKline, Novartis, Roche; Research grant / Funding (institution): AstraZeneca, GlaxoSmithKline, Novartis, Roche. All other authors have declared no conflicts of interest.