As an extension of the JAVELIN Solid Tumor trial, which has been assessing avelumab in multiple solid tumor settings, this is primarily a phase 1, open-label, dose-escalation trial in patients with metastatic castration-resistant prostate cancer (mCRPC). Patients who had progression of disease (PD) on an androgen receptor antagonist (ARA) were enrolled and treated with 10 mg/kg of avelumab. Restaging scans were completed every 6 weeks to determine PD, which was the primary clinical endpoint.
A total of 18 patients (median age 67, starting PSA 11 ng/mL, majority with Gleason >= 8 disease) were included in the study. Some of the patients (3) had received prior chemotherapy (docetaxel).
Ultimately, avelumab treatment appeared to be safe and tolerable. Only 2 patients had grade 3 asymptomatic treatment related adverse events (amylase & lipase elevations).
With regards to clinical efficacy, 7 patients had stable disease (SD) > 24 weeks post treatment, while 6 patients had PD after first restaging scans at 6 weeks which was reconfirmed in a 2nd restaging scan at 12 weeks. PSA doubling time (PSADT) prior to avelumab was compared with PSADT after 3 months of treatment. Among 17 patients with available data, 3 patients had a prolonged PSADT (defined at 3 months), 7 patients had stable PSADT and 7 had decreased PSADT.
As early results suggest some clinical efficacy without significant toxicity, future studies are warranted. This study continues to recruit patients.
Presented By: Farhad Fakhrejahani, MD, National Cancer Institute at the National Institutes of Health, Bethesda, MD
Co-Authors: Ravi Amrit Madan, William L. Dahut, Marijo Bilusic, Fatima Karzai, Lisa M Cordes, Julius Strauss, Jeffrey Schlom, James L. Gulley
Institution(s): National Cancer Institute at the National Institutes of Health, Bethesda, MD; National Cancer Institute, Bethesda, MD; National Institutes of Health, Bethesda, MD; Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD
Written By: Thenappan Chandrasekar, MD, Clinical Fellow, University of Toronto, Princess Margaret Cancer Centre, Toronto, Ontario, Canada
at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA