The Food and Drug Administration (FDA) approved avelumab in combination with axitinib for first-line treatment of patients with advanced renal cell carcinoma (RCC).
Approval was based on JAVELIN Renal 101 (NCT02684006), a randomised, multi-centre, open-label trial of avelumab plus axitinib in 886 patients with untreated advanced RCC regardless of tumour PD-L1 expression.
Patients were randomised to receive either avelumab 10 mg/kg intravenous infusion every 2 weeks in combination with axitinib 5 mg twice daily orally or sunitinib 50 mg once daily orally for 4 weeks followed by 2 weeks off until radiographic progression or unacceptable toxicity.
The main efficacy endpoints were progression-free survival (PFS), assessed by blinded independent central review using RECIST 1.1, and overall survival (OS) in patients with PD-L1-positive tumours.
Secondary endpoints were PFS and OS in the total population.
A statistically significant improvement in PFS was demonstrated in patients with PD-L1-positive tumours (HR 0.61; 95% CI: 0.48, 0.79; p=0.0001).
A statistically significant improvement in PFS in the total population was also demonstrated (HR 0.69; 95% CI: 0.56, 0.84; p=0.0002) at interim analysis.
Median PFS in the total population was 13.8 months for patients on the avelumab plus axitinib arm and 8.4 months for patients who received sunitinib.
With a median overall survival follow-up of 19 months, OS data were immature with 27% deaths in the intent-to-treat population.
The most common adverse reactions of avelumab in combination with axitinib in ≥ 20 percent of patients with RCC were diarrhoea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache.
Grade 3 or 4 hepatotoxicity occurred in 9 percent of patients and resulted in in permanent discontinuation of avelumab or axitinib in 7 percent.
Major cardiac adverse events occurred in 7 percent of patients treated with the combination.
The recommended avelumab dose for advanced RCC is 800 mg as an intravenous infusion every 2 weeks in combination with axitinib 5 mg orally twice daily.
Source: The Food and Drug Administration (FDA)
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