Nexavar misses in Phase III breast cancer trial
Onyx Pharmaceuticals Inc. and Bayer AG (Xetra:BAYN) said Nexavar sorafenib plus capecitabine missed the primary endpoint of improving progression-free survival (PFS) vs. placebo plus capecitabine in the Phase III RESILIENCE trial to treat locally advanced or metastatic breast cancer. The double-blind, international trial enrolled 537 patients with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane therapy, and resistant to or failed anthracycline or for whom further anthracycline is not indicated. The partners could not be reached for next steps for Nexavar in the indication.
Nexavar is approved for hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC) in more than 100 countries. The inhibitor of CRAF (RAF1) and multiple receptor tyrosine kinases is also approved in the U.S., Japan and Canada to treat differentiated thyroid carcinoma. Bayer and Onyx, now part of Amgen Inc. (NASDAQ:AMGN), have a worldwide co-development agreement for Nexavar outside of Japan, where Bayer owns rights. ...