FDA Grants Breakthrough Therapy Designation to Combination of Avelumab and Axitinib in Advanced Renal Cell Carcinoma

On December 21, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to avelumab (Bavencio) in combination with axitinib (Inlyta) for treatment-naive patients with advanced renal cell carcinoma.

“A combination approach with an immunotherapy, whose activity may complement existing agents such as axitinib, has the potential to improve outcomes for patients with advanced renal cancer—a disease where the 5-year survival rate remains low,” said Chris Boshoff, MD, PhD, Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development.

Renal cell carcinoma is the most common form of kidney cancer, with an estimated 57,500 new cases diagnosed in the United States in 2017. This disease is serious and life-threatening, and approximately 20% to 30% of patients are first diagnosed at an advanced or metastatic stage.

JAVELIN Renal 100

The Breakthrough Therapy designation is based on the preliminary evaluation of clinical data from JAVELIN Renal 100, a global phase Ib study assessing the safety and efficacy of avelumab in combination with axitinib for the treatment of treatment-naive patients with advanced renal cell carcinoma. Updated results from this phase Ib study were presented by Choueiri et al at the 2017 ASCO Annual Meeting (Abstract 4504).

According to the presented data, 54 patients were treated with avelumab for a median of 24.1 weeks, and 55 patients were treated with axitinib for a median of 25.3 weeks. The confirmed overall response rate for the combination was 54.5% (95% CI 40.6–68.0), based on 2 complete responses and 28 partial responses. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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