Long term quality of life with nivolumab, or in combination (ipilimumab) in advanced melanoma

Medical writer: Dr. Rachel H. Giles

Two new analyses of CheckMate 067 data determined that quality of life (QoL) 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 Phase 3, double-blind, randomised trial that evaluated the combination of nivolumab plus ipilimumab (n=314) or nivolumab monotherapy (n=316) vs. ipilimumab monotherapy (n=315) in a total of 945 patients with previously untreated advanced melanoma.

An analysis exploring long-term quality of life (QoL) and symptom burden found that QoL was maintained during the treatment-free interval (TFI) – 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 three months in the first year and then every six months.

Finally, a four-year analysis from the CheckMate 067 study of nivolumab and ipilimumab, alone or in combination, in patients with previously untreated unresectable or metastatic melanoma, showed that patient reported QoL and symptoms were maintained from baseline during extended treatment. Of 813 patients included in the PRO analysis population, QoL – 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. ASCO 2019, 31 May-4 June, Chicago, USA.
2. Taylor et al. Abstract 9568. ASCO 2019, 31 May-4 June, Chicago, USA.

Posted on 15 July 201925 March 2021