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2019 ASCO Annual Meeting!

Session: Melanoma/Skin Cancers

Type: Poster Session

Time: Monday June 3, 1:15 PM to 4:15 PM

Location: Hall A

Patient-reported quality of life (QoL) of advanced melanoma patients in a Phase 3 study of nivolumab (NIVO) with or without ipilimumab (IPI) versus IPI: CheckMate 067 4-year data.

Advanced Disease

Melanoma/Skin Cancers

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #122)

J Clin Oncol 37, 2019 (suppl; abstr 9551)

Author(s): Dirk Schadendorf, James M.G. Larkin, Jedd D. Wolchok, Vanna Chiarion-Sileni, Fiona Taylor, Rachael Lawrance, Alejandro Moreno-Koehler, Jennifer Lord-Bessen, Jasmine I. Rizzo, Andriy Moshyk, SRIVIDYA KOTAPATI, F. Stephen Hodi; Universitaetsklinikum Essen & German Cancer Consortium, Essen, Germany; Royal Marsden NHS Foundation Trust, London, United Kingdom; Memorial Sloan Kettering Cancer Center, New York, NY; Veneto Oncology Research Institute, Padua, Italy; Adelphi Values, Boston, MA; Adelphi Values, Bollington, Cheshire, MA, United Kingdom; Bristol Myers-Squibb, Princeton, NJ; Bristol-Myers Squibb, Princeton, NJ; Dana-Farber Cancer Institute, Boston, MA

Abstract Disclosures


Background: Early CheckMate 067 data showed maintenance of QoL in patients with advanced melanoma treated with NIVO with or without IPI based on 1-year data; however, the long-term QoL of these patients has not been evaluated previously. The patient-reported outcomes (PRO) analyses presented here for CheckMate 067 is the first time QoL results have been evaluated in this melanoma population over a 4-year period. Methods: In CheckMate 067, 945 patients were randomized 1:1:1 to receive NIVO (3mg/kg Q2W) + placebo (PBO), NIVO+IPI (1mg/kg+3mg/kg Q3W X 4) followed by NIVO (3mg/kg Q2W), or IPI (3mg/kg Q3W X 4) + PBO. PRO data were collected using the EORTC QLQ-C30 (5 functional domains, 9 symptoms, global health status) and EQ-5D-3L (utility index, VAS) at baseline, weeks 1 and 5 of each 6-week tx cycle, and off-tx follow-up (FU) visits. Mean changes in PRO scores from baseline (randomization) were evaluated descriptively for the PRO analysis population, with conclusions drawn from time points with ≥30 patients completing assessments per tx arm. Least square mean changes from baseline were assessed using a longitudinal mixed model analysis adjusting for repeated measures, including all on-tx data for patients. Results: Completion rates at baseline ranged from 89-92% across tx arms. Of 813 patients included in the PRO analysis population (278 NIVO, 274 NIVO+IPI, 261 IPI), > 200 receiving tx remained for the first year, > 100 receiving tx remained after 2 years, and > 50 receiving tx remained after 3 years. QoL, including assessment of functioning and symptom burden, was maintained for the duration of tx and in FU, with no sustained clinically meaningful deterioration in any tx arm. Global health status (EORTC QLQ-C30) and general QoL (EQ-5D-3L VAS) were also maintained during prolonged tx. Overall, results from the mixed model analysis support the long-term maintenance of QoL over the course of tx. Conclusions: Patient-reported QoL and symptoms in patients with advanced melanoma were maintained from baseline during extended tx with NIVO with or without IPI. Clinical trial information: NCT01844505

Other Abstracts in this Sub-Category:


1. Phase 3 international trial of adjuvant whole brain radiotherapy (WBRT) or observation (Obs) following local treatment of 1-3 melanoma brain metastases (MBMs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9500 First Author: Gerald Fogarty
Category: Melanoma/Skin Cancers - Advanced Disease


2. Efficacy and safety of the combination of nivolumab (NIVO) plus ipilimumab (IPI) in patients with symptomatic melanoma brain metastases (CheckMate 204).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9501 First Author: Hussein Abdul-Hassan Tawbi
Category: Melanoma/Skin Cancers - Advanced Disease


3. Salvage therapy after failure from anti-PD-1 single agent treatment: A Study by the German ADOReg melanoma registry.

Meeting: 2019 ASCO Annual Meeting Abstract No: 9505 First Author: Michael Weichenthal
Category: Melanoma/Skin Cancers - Advanced Disease