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ERBB Alteration Linked to Improved PFS With Afatinib in Urothelial Cancer

Tony Berberabe, MPH @OncBiz_Wiz
Published: Thursday, May 05, 2016
Peter H. O’Donnell, MD

Peter H. O’Donnell, MD

Five of 6 patients with metastatic urothelial cancer and at least 1 of 2 genetic alterations—multiple copies of HER2, or mutations and multiple copies of ERBB3—demonstrated a marked improvement in 3-month progression free survival (PFS3) of 6.6 months when given afatinib (Gilotrif), compared with patients who lacked these specific genetic abnormalities, according to researchers at the University of Chicago. In the study, 15 patients lacked these specific genetic abnormalities and demonstrated no significant response to the agent. A total of 23 patients were enrolled between November 2013 and May 2015.1

Historical treatments for chemotherapy-refractory metastatic bladder cancer have resulted in an average time to progression of about 2 months, said O’Donnell. Despite a number of agents investigated over the past 2 to 3 decades, time to progression has not changed. “Platinum-based therapy remains the only standard of care, with no approved second-line therapies in the US,” said O’Donnell. The median PFS for vinflunine, the only approved second-line agent in Europe, is 3.0 months,2 and the recently reported median PFS for pembrolizumab in its phase Ib trial was 2.2 months.3

The salient, exploratory endpoint for this trial was whether genomic alterations in EGFR, HER2, ERBB3, and ERBB4, including somatic mutations of all four genes plus copy number analysis of EGFR and HER2, were associated with PFS3 and response or both. “The patients that had the alterations and received afatinib had an average progression time of over 6 months. So that’s a 3-time prolongation, which is a signal that the drug is doing something,” said O’Donnell.
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