Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma

First-line pembrolizumab + axitinib significantly improved overall survival, progression-free survival, and objective response rate over sunitinib, while health-related quality of life outcomes were not different between groups. In the phase 3 KEYNOTE-426 (NCT02853331) trial, pembrolizumab + axitinib demonstrated improvement in overall survival, progression-free survival, and objective response rate over sunitinib monotherapy for advanced renal cell carcinoma (RCC). To evaluate health-related quality of life (HRQoL) in KEYNOTE-426. A total of 861 patients were randomly assigned to receive pembrolizumab + axitinib ( n = 432) or sunitinib ( n = 429). HRQoL data were available for 429 patients treated with pembrolizumab + axitinib and 423 patients treated with sunitinib. HRQoL end points were measured using the European Organisation for the Research and Treatment of Cancer Core (EORTC) Quality of Life Questionnaire (QLQ-C30), EQ-5D visual analog rating scale (VAS), and Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index—Disease-Related Symptoms (FKSI-DRS) questionnaires. Better or not different overall improvement rates from baseline between pembrolizumab + axitinib and sunitinib were observed for the FKSI-DRS (–0.79% improvement vs sunitinib; 95% confidence interval [CI] –7.2 to 5.6), QLQ-C30 (7.5% improvement vs sunitinib; 95% CI 1.0–14), and EQ-5D VAS (9.9% improvement vs sunitinib; 95% CI 3.2–17). For time to confirmed deterioration (TTcD) and time to first deterioration (TTfD), no differences were observed between arms for the QLQ-C30 (TTcD hazard ratio [HR] 1.0; 95% CI 0.82–1.3; TTfD HR 0.82; 95% CI 0.69–0.97) and EQ-5D VAS (TTcD HR 1.1; 95% CI 0.87–1.3; TTfD HR 0.98; 95% CI 0.83–1.2). TTfD was not different between treatment arms (HR 1.1; 95% CI 0.95–1.3) for the FKSI-DRS, but TTcD favored sunitinib (HR 1.4; 95% CI 1.1–1.7). Patients were assessed during the off-treatment period for sunitinib, which may have underestimated the negative impact of sunitinib on HRQoL. Overall, patient-reported outcome scales showed that results between the pembrolizumab + axitinib and sunitinib arms were not different, with the exception of TTcD by the FKSI-DRS. Compared with sunitinib, pembrolizumab + axitinib delays disease progression and extends survival, while HRQoL outcomes were not different between groups.