A Phase III trial evaluating the efficacy and safety of the addition of Roche’s Tarceva (erlotinib) tablets to German drug major Bayer’s (BAYN: DE) Nexavar (sorafenib) - which is being commercialized with Onyx Pharmaceuticals (Nasdaq: ONXX) and Japan’s Astellas Pharma - for patients with hepatocellular carcinoma (HCC; liver cancer) did not further improve overall survival versus the standard therapy with Nexavar alone.
The SEARCH (Sorafenib and Erlotinib, a rAndomized tRial protoCol for the treatment of patients with Hepatocellular carcinoma) trial compared Nexavar in combination with Tarceva to Nexavar alone. 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. Data from this study will be presented at an upcoming scientific meeting. Nexavar generated sales of 750 million euros ($912.6 million) for Bayer last year.
"The data from SEARCH showed that the addition of Tarceva to Nexavar did not provide additional benefit to patients with HCC," said Dimitris Voliotis, vice president, global clinical development oncology at Bayer HealthCare; adding: "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."
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