FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA

Merck KGaA announced the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC). Breakthrough Therapy Designation is designed to accelerate the development and review of potential medicines for serious conditions, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over currently available therapies on one or more clinically significant endpoints. This is the second Breakthrough Therapy Designation granted to avelumab.

"A combination approach with an immunotherapy, whose activity may complement existing agents such as INLYTA, has the potential to improve outcomes for patients with advanced renal cancer - a disease where the five-year survival rate remains low," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "Pfizer's expertise in developing treatments for advanced RCC is a distinct advantage in tackling this tumor type, and we look forward to the completion of our Phase III study combining avelumab with INLYTA, which we're expecting at the end of next year."

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

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 INLYTA for the treatment of treatment-naïve patients with advanced RCC. The FDA previously granted avelumab Breakthrough Therapy Designation for the treatment of patients with metastatic Merkel cell carcinoma (mMCC) whose disease has progressed after at least one previous chemotherapy regimen.

The clinical development program for avelumab, known as JAVELIN, involves at least 30 clinical programs and over 7,000 patients evaluated across more than 15 different tumor types. This includes JAVELIN Renal 101, a randomized, Phase III, open-label, multicenter trial investigating avelumab in combination with INLYTA versus sunitinib as a first-line treatment option for advanced RCC, which recently completed recruitment. In addition to RCC, cancer studies in the JAVELIN program include non-small cell lung cancer, breast cancer, head and neck cancer, Hodgkin's lymphoma, melanoma, mesothelioma, MCC, ovarian cancer, gastric/gastroesophageal junction cancer, and urothelial carcinoma (UC).