Bayer HealthCare Pharmaceuticals, Onyx Pharmaceuticals, Inc. and Astellas Pharma Inc. have announced results from phase III trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib) tablets to Nexavar (sorafenib) tablets did not improve overall survival for patients with unresectable hepatocellular carcinoma (HCC) vs. 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 there were no new or unexpected toxicities or changes to the respective product safety profiles observed. Data from this study will be presented at an upcoming scientific meeting.
Nexavar is jointly developed by Bayer and Onyx. Tarceva is jointly marketed by Astellas and Genentech, a member of the Roche Group.
“The data from SEARCH showed that the addition of Tarceva to Nexavar did not provide additional benefit to patients with unresectable HCC,” said Dr Dimitris Voliotis, vice president, global clinical development oncology, Bayer HealthCare. “The results of this trial confirm the efficacy and safety profile of Nexavar in the treatment of unresectable liver cancer.”
The SEARCH trial was an international multicenter placebo-controlled phase III study that randomized 720 patients with advanced liver cancer. The study examined whether the addition of Tarceva to Nexavar prolongs survival as compared to Nexavar alone in patients with unresectable HCC. The primary endpoint of the study was overall survival (OS) and the secondary endpoints were safety, time to radiographic progression (TTP), disease control rate (DCR) and patient-reported outcome. 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.
Hepatocellular carcinoma (HCC) is the most common form of liver cancer and is responsible for approximately 90 per cent of the primary liver cancers in adults. Liver cancer is the seventh most common cancer in the world and the third leading cause of cancer-related deaths globally.
Nexavar is approved in the US for the treatment of patients with unresectable hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma. Nexavar is thought to inhibit both the tumour cell and tumour vasculature. In preclinical studies, Nexavar has been shown to inhibit multiple kinases thought to be involved in both cell proliferation (growth) and angiogenesis (blood supply) – two important processes that enable cancer growth. These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in more than 100 countries. Nexavar is also being evaluated by Bayer and Onyx, international study groups, government agencies and individual investigators in a range of cancers.
Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy. (Maintenance treatment). Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least 1 chemotherapy regimen. (2nd/3rd-line treatment). Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
Tarceva in combination with gemcitabine is prescribed for patients with advanced stage pancreatic cancer whose cancer has spread, grown, or cannot be surgically removed and who have not received previous chemotherapy.
Bayer HealthCare Pharmaceuticals Inc. is the US-based pharmaceuticals business of Bayer HealthCare LLC. The company is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.
Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. The company is focused on developing novel medicines that target key molecular pathways.
Astellas Pharma Inc., is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.