The Food and Drug Administration (FDA) approved avelumab for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
Efficacy of avelumab for maintenance treatment of UC was investigated in the JAVELIN Bladder 100 trial (NCT02603432), a randomised, multi-centre, open-label trial that enrolled 700 patients with unresectable, locally advanced or metastatic urothelial carcinoma that had not progressed with four to six cycles of first-line platinum-containing chemotherapy.
Patients were randomised (1:1) to receive either avelumab intravenously every 2 weeks plus best supportive care (BSC) or BSC alone.
Treatment was initiated within 4-10 weeks after last chemotherapy dose.
The main efficacy outcome measures were overall survival (OS) in all patients and in patients with PD-L1-positive tumours.
The median OS in all patients was 21.4 months in the avelumab arm and 14.3 months in the BSC alone arm (HR: 0.69; 95%CI: 0.56, 0.86; p=0.001).
Among patients with PD-L1-positive tumours (51%), the HR for OS was 0.56 (95% CI: 0.40, 0.79; p<0.001).
In an exploratory analysis of patients with PD- L1- negative tumours (39%), the OS hazard ratio was 0.85 (95% CI: 0.62, 1.18).
The most common adverse reactions in > 20% of patients who received avelumab were fatigue, musculoskeletal pain, urinary tract infection, and rash.
One patient died from sepsis and 28% of patients had serious adverse reactions.
The recommended avelumab dose is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
The results from this study supported the conversion of accelerated approval of avelumab to a regular approval.
Source: The Food and Drug Administration (FDA)
Watch our interview with Prof Thomas Powles about the JAVELIN Bladder 100 trial here.