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FDA Approves Avelumab–Axitinib Combo for First-Line Treatment of Advanced RCC
The FDA has approved avelumab (Bavencio; EMD Serono) for use in combination with axitinib (Inlyta; Pfizer) in the first-line treatment of patients with advanced renal cell carcinoma (RCC). The application for this approval was granted priority review and Breakthrough Therapy designation by the FDA.
This approval was based on the multi-center, open-label JAVELIN Renal 101 clinical trial of 886 treatment-naïve patients with advanced RCC, regardless of tumor PD-L1 expression. Patients were randomized to receive avelumab 10 mg/kg every 2 weeks plus axitinib 5 mg twice daily or sunitinib 50 mg once daily for 4 weeks followed by 2 weeks without treatment until radiographic progression or unacceptable toxicity occur.
The main end points of the JAVELIN Renal 101 study were progression-free survival (PFS) and overall survival (OS) in patients with PD-L1–positive tumors, and secondary end points were PFS and OS in the total population.
Patients with PD-L1–positive tumors had a statistically significant improvement in PFS (hazard ratio [HR], 0.61; 95% CI, 0.48-0.79; P = .0001), as did patients in the total population (HR, 0.69; 95% CI, 0.56-0.84; P = .0002) at interim analysis. In the total population, the median PFS was 13.8 months with avelumab plus axitinib versus 8.4 months with sunitinib.
The most common (≥20%) adverse events reported with avelumab plus axitinib in patients with RCC were diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache.—Hina Khaliq
Source: US Food and Drug Administration. FDA approves avelumab plus axitinib for renal cell carcinoma. Updated May 15, 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-avelumab-plus-axitinib-renal-cell-carcinoma. Accessed May 16, 2019.
