A27: Effect of nivolumab (NIVO) on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): results of a phase III study (CheckMate 066)

Georgina Long1,Victoria Atkinson2,Paolo Ascierto3,Caroline Robert4,Jessica Hassel5,Piotr Rutkowski6,Kerry Savage7,Fiona Taylor8,Cheryl Coon8,Isabelle Gilloteau9,Homa Dastani9,Ian Waxman9,Amy Abernethy10

1Melanoma Institute Australia, North Sydney, NSW, Australia,2Gallipoli Medical Research Foundation and Princess Alexandra Hospital, Queensland, Australia,3Istituto Nazionale Tumori Fondazione Pascale, Napoli, Italy,4Institut Gustave-Roussy, Paris, France,5University Hospital Heidelberg, Dep. of Dermatology and National Center for Tumor Diseases, Heidelberg, Germany,6Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland,7BC Cancer Agency, University of British Columbia, Vancouver, BC, Canada,8Adelphi Values, Boston, MA, USA,9Bristol-Myers Squibb, Princeton, NJ, USA,10Duke Cancer Institute, Durham, NC, USA

Presenting date: Monday 2 November
Presenting time: 12.20-13.10

Background

Background: Newer treatments have extended survival in advanced MEL but quality of survival is rarely evaluated. Treatments demonstrating increased survival while preserving long-term QoL are needed. In a phase III, randomized, double-blind study, NIVO (a PD-1 immune checkpoint inhibitor) improved overall survival compared with dacarbazine (DTIC) in treatment-naïve pts with advanced MEL.

Method

Methods: QoL, measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol-five dimension questionnaire (EQ-5D), was evaluated at baseline (BL) and at treatment cycles Q6W. Mean changes and non-parametric comparisons are reported.

Results

Results: 418 pts were randomized to NIVO (n=210) or DTIC (n=208). Adjusted completion rates at BL for EQ-5D utilities were 69.5% (NIVO) and 64.9% (DTIC), and for EORTC QLQ-C30 were 70.0% (NIVO) and 64.9% (DTIC). While rates remained similar throughout the study, analysis of QoL involving DTIC was not feasible after wk 13 due to a high attrition rate (n?41). Mean BL QoL scores were similar for NIVO versus DTIC (EQ-5D utilities: 0.778 vs 0.711; EQ-5D visual analog scale [VAS] scores: 70.9 vs 69.1; EORTC Global Health: 68.9 vs 66.2). No QoL change was noted for DTIC prior to study dropout. For NIVO, improvements from BL were noted in EQ-5D utilities from wk 7 (0.027; n=132; P=0.011) through wk 49 (0.045; n=38; P=0.034), and in EQ-5D VAS scores at wks 25, 31, 37, 49 and 61 (P?0.03). EORTC subscale scores did not change over time.

Conclusion

Conclusions: Results demonstrate that NIVO does not impair and may enhance QoL compared with BL, while also conferring survival benefits in treatment-naïve pts with advanced MEL. Dropout rates limited QoL data interpretation for DTIC.