Avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with previously treated, recurrent or refractory ovarian cancer: A phase Ib, open-label expansion trial.

Gynecologic Cancer
Session Type and Session Title: 
Clinical Science Symposium, Intersection of the Mutanome and the Immunome
Abstract Number: 


J Clin Oncol 33, 2015 (suppl; abstr 5509)
Mary L. Disis, Manish R. Patel, Shubham Pant, Jeffrey R. Infante, A. Craig Lockhart, Karen Kelly, Joseph Thaddeus Beck, Michael S. Gordon, Glen J. Weiss, Samuel Ejadi, Matthew Hiram Taylor, Anja von Heydebreck, Kevin M. Chin, Jean-Marie Cuillerot, James L. Gulley; University of Washington School of Medicine, Seattle, WA; Sarah Cannon Research Institute/Florida Cancer Specialists, Sarasota, FL; Peggy and Charles Stephenson Oklahoma Cancer Center, Oklahoma City, OK; Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Washington University School of Medicine, St. Louis, MO; UC Davis Comprehensive Cancer Center, Sacramento, CA; Highlands Oncology Group, Rogers, AR; Pinnacle Oncology Hematology, Scottsdale, AZ; Western Regional Medical Center, Cancer Treatment Centers of America, Goodyear, AZ; Virginia G. Piper Cancer Center, Scottsdale, AZ; Oregon Health & Science University, Portland, OR; Merck KGaA, Darmstadt, Germany; EMD Serono, Billerica, MA; National Cancer Institute, National Institutes of Health, Bethesda, MD

Abstract Disclosures


Background: The programmed death-1 receptor (PD-1) and its ligand (PD-L1) are key therapeutic targets in the reactivation of the immune response against multiple cancers. Avelumab (proposed INN) (MSB0010718C) is a fully human anti-PD-L1 IgG1 antibody currently being investigated in clinical trials. Here we present results from a cohort of patients (pts) with recurrent or refractory ovarian cancer in an ongoing phase Ib study (NCT01772004). Methods: Pts with ECOG PS 0-1 received avelumab at 10 mg/kg Q2W. Best overall response (BOR) and progression-free survival (PFS) were assessed according to RECIST 1.1. Adverse events (AEs) were evaluated by CTCAE v4.0. A prespecified analysis of 23 pts with follow-up of ≥ 2 months showed confirmed and unconfirmed partial responses (PRs), leading to cohort expansion to 75 pts. Results: Seventy-five pts were enrolled from November 2013 to November 2014 (median age 62 [range 38-84]; ECOG PS 0 [41%] or 1 [59%]; median of four prior lines of therapy). As of January 2015, median duration of treatment with avelumab was 10 weeks (range 2-54 weeks), and 27 pts remained on treatment. Efficacy data from the 23 pts followed-up for ≥ 2 months (range 2–8 months) demonstrated 4 pts (17.4%, [95% CI, 5.0%, 38.8%]) achieved an unconfirmed BOR of PR,11 (47.8%) had stable disease, and 2 pts had >30% tumor shrinkage after progression was reported. Median PFS was 11.9 weeks (95% CI, 5.9, not reached), and the PFS rate at 24 weeks was 33.3% (95% CI, 11.5, 57.2). Drug-related treatment-emergent AEs (TEAEs; all grades) were reported in 18 pts (78.3%), and 2 pts (8.7%) experienced grade ≥ 3 drug-related TEAEs (increased lipase [1] and elevated creatine kinase and autoimmune myositis that led to discontinuation [1]). No drug-related serious TEAEs occurred. The most commonly reported drug-related TEAEs (> 10%) were fatigue, nausea, and diarrhea. Conclusions: These data represent the largest reported dataset of pts with recurrent ovarian cancer treated with anti-PD-L1 therapy. Avelumab demonstrated an acceptable safety profile and is clinically active in this heavily pretreated ovarian cancer pt population. Clinical trial information: NCT01772004