Health-related quality of life (QoL) in patients with advanced melanoma receiving immunotherapies in real-world clinical practice settings

Background: Pembrolizumab (PEMBRO) and ipilimumab + nivolumab (IPI + NIVO) are approved advanced melanoma (AM) immunotherapies. To address limited health-related quality of life (QoL) real-world evidence with immunotherapies in AM, we compared QoL in AM patients receiving either treatment in clinical practice. Methods: A prospective US observational study enrolled adult AM patients initiating first-line PEMBRO or IPI + NIVO between June 2017 and March 2018. Endpoints included the QLQ-C30 global health score (GHS) and EuroQol visual analog scale (EQ-VAS) scores. Mean changes were compared using repeated measures mixed-effects models and are presented covariate adjusted. Results: 225 PEMBRO and 187 IPI + NIVO patients were enrolled. From baseline through week 24, PEMBRO was associated with 3.2 mean GHS score increase (95% CI 0.5, 5.9; p =.02), while no change was observed with IPI + NIVO; 0.2 (95% CI − 2.6, 3.0; p = 0.87). Among objective treatment-responders, GHS scores associated with PEMBRO increased 6.0 (95% CI 3.1, 8.8; p <.0001); IPI + NIVO patients increased 3.8 (95% CI 0.8, 6.9; p =.01). In treatment non-responders, IPI + NIVO was associated with GHS/QoL deterioration of − 3.7 (95% CI − 6.8, − 0.6; p =.02), PEMBRO non-responders demonstrated no change; 0.7 (95% CI − 2.3, 3.7; p = 0.6). Between treatments, PEMBRO patients increased 2.6 greater in EQ-VAS (95% CI 0.6, 4.5; p =.01) vs IPI + NIVO at 24 weeks. Conclusions: PEMBRO was associated with better 24-week QoL compared to IPI + NIVO in actual clinical practice settings. Real-world data has known limitations, but with further confirmation these results may have implications for treatment selection.