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FDA approves avelumab plus axitinib as frontline treatment for advanced renal cell carcinoma
By: Stijn van den Borne, MSc | Last updated: 14th May 2019 | In: Genitourinary Cancer, ImmunoOncology, Immunotherapy, US FDA Onc\Haem Approvals
axitinib, Bavencio, FDA, Inlyta, Merck KGaA, Merck Serono, Merckgroup, mRCC, Pfizer, RCC, renal cancer
On 14 May 2019, the FDA approved the combination of avelumab (Bavencio®, Merck KGaA/Pfizer) plus axitinib (Inlyta®, Pfizer) for the first-line treatment of advanced renal cell carcinoma (RCC) patients.
JAVELIN Renal 101
The FDA approval was based on the randomised, multicentre, open-label JAVELIN Renal 101 trial (NCT02684006) comparing the combination of avelumab plus axitinib vs sunitinib 1:1 in 886 untreated advanced RCC patients regardless of tumour PD-L1 expression. The primary efficacy endpoints included the progression-free survival (PFS) by blinded independent central review (RECIST 1.1) and overall survival (OS) in PD-L1 positive patients. The secondary endpoints were the PFS and OS in the overall study population. Study treatments were provided until radiographic progression or unacceptable toxicity.
The JAVELIN Renal 101 showed a significant improvement in PFS favouring patients with PD-L1-positive tumours treated with the combination avelumab plus axitinib and when compared to sunitinib (HR=0.61; 95% CI, 0.48-0.79; P=0.0001). Moreover, at interim analysis, a statistically significant improvement in PFS for the overall study population was demonstrated (HR=0.69; 95% CI, 0.56-0.84; P=0.0002). The median PFS in the overall study population was 13.8 months treated with avelumab plus axitinib vs 8.4 months for patients treated with sunitinib. At a median follow-up for OS of 19 months, 27% of deaths occurred in the intent-to-treat population. The OS data were not yet mature at the time of analysis.
Common adverse reactions in ≥20% of RCC patients treated with avelumab plus axitinib included diarrhoea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnoea, abdominal pain, and headache. Nine per cent of patients experienced Grade 3 and 4 hepatotoxicities resulting in permanent discontinuation of avelumab or axitinib in 7% of patients. Finally, major cardiac adverse events occurred in 7% of patients who received the combination of PD-L1 antibody plus VEGFR tyrosine kinase inhibitor.
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