Bayer HealthCare Pharmaceuticals, affiliate of German conglomerate Bayer AG (BAYRY.PK, BAYZF.PK), as well as Onyx Pharmaceuticals, Inc. (ONXX), and Japan's Astellas Pharma Inc. on Monday said the addition of cancer drug Tarceva to standard therapy Nexavar in a Phase III trial in patients with Hepatocellular carcinoma did not improve overall survival than Nexavar alone.
Nexavar is jointly developed by Bayer and Onyx, while Tarceva is jointly marketed by Astellas and Genentech, a member of the Roche Holding AG (RHHBY.PK).
The SEARCH (Sorafenib and Erlotinib, a rAndomized tRial protoCol for the treatment of patients with Hepatocellular carcinoma) trial examined whether the addition of Tarceva tablets to Nexavar prolongs survival. In the trial, patients were randomized to receive either 400 mg of Nexavar twice daily and 150 mg of Tarceva once daily or 400 mg of Nexavar twice daily with matching placebo.
The primary endpoint of the study was overall survival and the secondary endpoints were safety, time to radiographic progression, disease control rate and patient-reported outcome.
Hepatocellular carcinoma is the most common form of liver cancer and is responsible for approximately 90 percent of the primary liver cancers in adults.
Nexavar, an oral anti-cancer therapy, is approved for patients with inoperable liver cancer and advanced kidney cancer. Tarceva is approved for patients with advanced non-small cell lung cancer.
Bayer's Dimitris Voliotis said, "The data from SEARCH showed that the addition of Tarceva to Nexavar did not provide additional benefit to patients with HCC. The results of this combination trial confirm the proven efficacy and safety profiles of Nexavar in HCC. Nexavar is approved for patients with inoperable liver cancer and advanced kidney cancer."
According to the companies, the safety and tolerability of the treatment combination were generally as expected based upon experience and use of the two products alone and did not show any new or unexpected toxicities or changes to the respective product safety profiles.
The companies will present the data from this study at an upcoming scientific meeting.
Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of other cancers.
On Frankfurt's Xetra, Bayer shares lost 0.22 percent and currently trading at 58.41 euros.
Onyx shares closed Friday's trading at $76.38, up $7.98 or 11.67 percent in the U.S.
Astellas shares closed today's trading in Japan at 3,615 yen, down 25 yen or 0.69 percent.
For comments and feedback: editorial@rttnews.com