Dr. Ornstein on the Efficacy of Neoadjuvant Avelumab and Axitinib in RCC

Moshe Ornstein, MD, MA, Department of Hematology and Medical Oncology, Cleveland Clinic, discusses the efficacy findings from a phase 2 trial (NCT03341845) examining neoadjuvant avelumab (Bavencio) and axitinib (Inlyta) in renal cell carcinoma (RCC).

The phase 2 trial examined the use of neoadjuvant avelumab and axitinib in patients with RCC who were at high risk of relapse after nephrectomy.

Of the 40 patients enrolled on the trial, 70% were male and the median age was 63, spanning a range of high-risk categories, Ornstein says. Notably, 43% of patients had node-positive disease, 20% of patients were T-4, and 28% of patients had a Fuhrman grade of 3 or 4, Ornstein explains.

The objective response rate was 30%, with all of those patients achieving a partial response, Ornstein says. Furthermore, 83% (n = 10) of the patients who had a response remained disease-free at the time of study follow-up, Ornstein explains.

Secondary end points of disease-free survival and overall survival were not met. However, at a median follow up of approximately 2 years, recurrence was seen in about one-third of patients, leaving approximately two-thirds of patients disease-free, Ornstein concludes.