Highlights from

ASCO 2019

American Society of Clinical Oncology annual meeting

Chicago, USA 31 May - 4 June 2019

Findings from 2 studies indicate sustained long-term quality of life: nivolumab with or without ipilimumab in previously untreated advanced melanoma

Two new analyses of CheckMate 067 data determined that quality of life was maintained throughout the course of treatment (either nivolumab alone or with ipilimumab), on long-term (4-year) follow-up and, importantly, that these benefits persisted when the patients were off therapy [1,2].

The phase 3 CheckMate 067 was a double-blind, randomised trial that evaluated the combination of nivolumab plus ipilimumab (n=314) or nivolumab monotherapy (n=316) versus ipilimumab monotherapy (n=315) in a total of 945 patients with previously untreated advanced melanoma.

An analysis exploring long-term quality of life and symptom burden found that quality of life was maintained during the treatment-free interval –the period where a patient is off study treatment and free of subsequent therapy– in patients with previously untreated unresectable or metastatic melanoma following discontinuation of therapy with nivolumab or nivolumab plus ipilimumab. Patient-reported outcome (PRO) scores were maintained from last on-treatment visit to follow-up 1 (30 days after the last dose) or follow-up 2 (84 days after follow-up 1) for patients who discontinued treatment. PRO scores remained stable beyond follow-up 2 for the EQ-5D-3L (measures of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), which were collected at survival follow-up visits every 3 months in the first year and then every 6 months.

Finally, the 4-year analysis from the CheckMate 067 trial also showed that patient-reported quality of life and symptoms were maintained from baseline during extended treatment. Of 813 patients included in the PRO analysis population, quality of life –including an assessment of functioning and symptom burden– was maintained for the duration of treatment and in follow-up, with no sustained clinically meaningful deterioration in any treatment arm.

  1. Schadendorf et al. Abstract 9551. 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. ASCO 2019, 31 May-4 June, Chicago, USA.
  2. Taylor et al. Abstract 9568. Quality of life (QoL) and symptom burden in patients (pts) with advanced melanoma during the treatment-free interval (TFI) after discontinuation of nivolumab (NIVO) or NIVO plus ipilimumab (IPI). ASCO 2019, 31 May-4 June, Chicago, USA.

The content and interpretation of these conference highlights are the views and comments of the speakers/authors.