Avelumab in Recurrent or Refractory Ovarian Cancer


Key Points

  • Objective response was observed in 9.6% of patients and stable disease in 42.4%.
  • Median duration of response was 10.4 months, with 5 responses ongoing at time of analysis.

In phase Ib results from the JAVELIN Solid Tumor Trial reported in JAMA Oncology, Disis et al found that avelumab produced durable responses in some patients with recurrent or refractory ovarian cancer.

In the study, an expansion cohort of 125 women with advanced disease who had received chemotherapy including a platinum agent were enrolled between November 2013 and August 2015 and treated with avelumab at 10 mg/kg every 2 weeks until disease progression, unacceptable toxicity, or study withdrawal. Patients had a median age of 62.0 years (range = 27–84 years) and had received a median of 3 prior lines of treatment (range = 0–10) for advanced disease.

Response Rates

Median follow-up was 26.6 months. Confirmed objective response on Response Evaluation Criteria in Solid Tumors, version 1.1 criteria occurred in 12 patients (9.6%), including a complete response in 1. Responses occurred in patients irrespective of tumor programmed cell death ligand 1 status. Median duration of response was 10.4 months (95% confidence interval = 4.2 months–not estimable), with 5 patients having an ongoing response at data cutoff.

Stable disease of any duration was observed in an additional 53 patients (42.4%), yielding a disease control rate of 52.0%. Response on immune criteria was observed in 16 patients (12.8%). Progression-free survival at 1 year was 10.2%. Median overall survival was 11.2 months.


Infusion-related reactions occurred in 20.0% of patients. Other frequent treatment-related adverse events of any grade were fatigue (13.6%), diarrhea (12.0%), and nausea (11.2%).

Grade ≥ 3 treatment-related adverse events occurred in 7.2%, with the most common being increased lipase (2.4%). Immune-mediated adverse events of any grade occurred in 16.8% of patients, with grade ≥ 3 events in 2.4%. No treatment-related deaths were observed.

The investigators concluded, “Avelumab demonstrated antitumor activity and acceptable safety in heavily pretreated patients with recurrent or refractory ovarian cancer.”

Mary L. (Nora) Disis, MD, of UW Medicine Cancer Vaccine Institute, University of Washington School of Medicine, is the corresponding author for the JAMA Oncology article.

Disclosure: The study was supported by Merck KGaA. The study authors' full disclosures can be found at

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®.