Amgen Splits AMG-706/Avastin Head-To-Head NSCLC Study Into Two Trials
This article was originally published in The Pink Sheet Daily
Executive Summary
One trial will compare the multi-VEGF agent with Avastin in non-squamous non-small cell lung cancer and the second will study AMG-706’s effect in all non-small cell carcinoma patients.
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Amgen no longer plans to compare its multi-targeted vascular endothelial growth factor agent AMG-706 with Genentech's Avastin in a single head-to-head trial. Instead, the company intends to conduct one head-to-head study in a narrower non-small cell lung cancer population and run a second NSCLC trial in a broader group. Amgen said it decided to break up the trial due to the possibility that AMG-706 could be active in a broader population of lung cancer patients than Avastin, the firm announced during its first quarter earnings call April 19. A Phase II study, which Amgen expects to initiate in late 2006 or early 2007, will compare AMG-706 to Avastin (bevacizumab) in non-squamous NSCLC patients. Avastin, which is approved for treatment of metastatic colorectal cancer, is pending at FDA for first-line, non-squamous NSCLC (1 (Also see "Genentech Aims To Extend Avastin Duration Of Use" - Pink Sheet, 12 Apr, 2006.)). A separate Phase III trial, slated to begin in late 2006, will study AMG-706 in undifferentiated NSCLC patients. Amgen Exec VP-Research & Development Richard Perlmutter explained that Avastin could not be used as a comparator in the overall advanced NSCLC population because "there's an exclusion in Avastin treatment for patients with squamous cell carcinoma." "During the quarter, we received input from leading authorities. They would like to see the study broadened in order to understand the impact of AMG-706 in non-small cell lung cancer, circumstances beyond those currently treated by Avastin. Consequently, Avastin cannot be used as the global comparator for this study," he said. "We decided to split it into two studies to take advantage of the fact that we could use Avastin in the adenocarcinoma setting," Perlmutter added. AMG-706 works differently from Avastin, also a VEGF inhibitor, in that it has been shown to block multiple pathways simultaneously, Amgen said. Further, it is administered orally rather than intravenously. The firm also expects to initiate a head-to-head trial of AMG-706 and Avastin in HER2 negative metastatic breast cancer patients during the second or third quarter. Amgen is also advancing AMG-706 in trials as a treatment for Gleevec -resistant gastrointestinal stromal tumors. Amgen expects interim Phase II GIST data in the second quarter. The full approval of Pfizer's Sutent in the treatment of gastrointestinal stromal tumors removes the prospect of accelerated approval for AMG-706 in this setting, Amgen said. FDA cleared sunitinib for the claim in January (2 (Also see "Pfizer's Sutent Receives Dual Approvals For Kidney Cancer & Stomach Cancer" - Pink Sheet, 26 Jan, 2006.)). It has been suggested that it will be more difficult for oncologics to receive accelerated approval in the future due to the increasingly large number of settings where products have demonstrated benefit. -Todd Leeuwenburgh |