Patient-Reported Outcomes in a Phase 2 Study Comparing Atezolizumab Alone or With Bevacizumab Versus Sunitinib in Previously Untreated Metastatic Renal Cell Carcinoma.

OBJECTIVE: To evaluate patient-reported outcome (PRO) data from IMmotion150. The phase 2 IMmotion150 study showed improved progression-free survival with atezolizumab plus bevacizumab versus sunitinib in patients with PD-L1+ tumours and suggested activity of atezolizumab monotherapy in previously untreated metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: Patients with previously untreated mRCC were randomised to atezolizumab 1200 mg intravenously (IV) every 3 weeks (n = 103), the atezolizumab regimen plus bevacizumab 15 mg/kg IV every 3 weeks (n = 101), or sunitinib 50 mg orally daily (4 weeks on, 2 weeks off; n = 101). MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle. Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores were reported for all comers. TTD was the first >/= 2-point score increase over baseline. Absolute effect size >/= 0.2 suggested a clinically important difference with checkpoint inhibitor therapy versus sunitinib. RESULTS: Completion rates were > 90% at baseline and >/= 80% at most visits. Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference was observed with atezolizumab (both alone and in combination) versus sunitinib. Improved TTD (HR [95% CI]) was more pronounced with atezolizumab monotherapy: core symptoms, 0.39 (0.22-0.71); RCC symptoms, 0.22 (0.12-0.41); and symptom interference, 0.36 (0.22-0.58). Change from baseline by visit, evaluated by the MDASI, also showed a trend favouring atezolizumab monotherapy versus sunitinib. Small sample sizes may have limited the ability to draw definitive conclusions. CONCLUSION: PROs suggested that atezolizumab alone or with bevacizumab maintained daily function compared with sunitinib. Notably, symptoms were least severe with atezolizumab alone versus sunitinib. (IMmotion150; NCT01984242.).