The checkpoint inhibitors pembrolizumab and nivolumab not only prolong survival in advanced melanoma patients but also maintain health-related quality of life.
The checkpoint inhibitors pembrolizumab and nivolumab not only prolong survival in advanced melanoma patients but also maintain health-related quality of life (QoL), according to two presentations at the Society for Melanoma Research 2015 International Congress, held November 18–21 in San Francisco.
In the international, randomized, open-label phase III KEYNOTE-006 study, the anti–programmed death-1 (PD-1) humanized monoclonal antibody pembrolizumab provided superior overall survival (OS), progression-free survival (PFS), and response, and with less high-grade toxicity compared with the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor ipilimumab in 834 patients with ipilimumab-naive advanced melanoma who received up to one prior therapy.
Patient-reported outcomes assessments were completed by 773 patients, reported Teresa Petrella, MD, of the Sunnybrook Health Sciences Centre at the University of Toronto in Toronto, Canada. Pembrolizumab was associated with significantly less deterioration in health-related QoL at week 12 compared with ipilimumab. Patients who received pembrolizumab had significantly smaller decreases from baseline in global health status scores, less deterioration in functioning scales, and improvement in emotional functioning, she said.
The time to deterioration in the global health status score was significantly longer among those who took pembrolizumab as compared with ipilimumab. “This is likely because of the improvement in PFS and OS and the lower incidence of high-grade toxicity with pembrolizumab,” Petrella said.
In conclusion, Petrella said: “Health-related QoL was maintained to a greater degree with pembrolizumab than with ipilimumab. Combined with superior efficacy and lower incidence of high-grade toxicity provided by pembrolizumab, the data further support pembrolizumab as a new standard therapy of care for patients with advanced melanoma.”
In the phase III, randomized, double-blind CheckMate 066 study, the anti–PD-1 monoclonal antibody nivolumab was compared with the alkylating agent dacarbazine in 418 treatment-naive patients who had melanoma without a BRAF mutation. Nivolumab demonstrated superior OS and a significantly higher response rate than dacarbazine, with fewer treatment-related grade 3/4 adverse events.
In addition to efficacy and safety, health-related QoL and healthcare resource use “are important factors to consider when evaluating the value of new agents for melanoma,” said Georgina Long, BSc, PhD, MBBS, of the Melanoma Institute Australia in Sydney, Australia.
More than two-thirds of the patients completed baseline QoL questionnaires. Nivolumab generally showed no deterioration in health-related QoL during treatment, she said. Improvement in QoL scores with nivolumab was clinically meaningful at week 37.
Across 61 weeks, significant improvements were identified with nivolumab in some functioning scales, but none of the changes were clinically meaningful.
There were no significant differences between the two arms in the number of hospital visits or hospital duration, and the proportion of patients with hospital visits was similar.
In conclusion, Dr. Long said: “In CheckMate 006, in addition to the survival benefits observed with nivolumab when compared with dacarbazine, nivolumab was associated with improvements in health-related QoL over time. Statistically significant improvements in QoL were observed, which were clinically meaningful at certain time points.”
Treatment with nivolumab did not result in increased healthcare resource use compared with dacarbazine, she added.
The results “further support the clinical benefit of nivolumab in patients with melanoma, without impact on healthcare resources,” she said.