July 23, 2012
Combination of
Tarceva, Nexavar fails to meet main goal of Phase III liver cancer
study
Last Updated:July 23, 2012 07:36
Bayer, Onyx Pharmaceuticals and Astellas announced Monday that a late-stage
trial investigating the combination of Tarceva (erlotinib) and Nexavar
(sorafenib) failed to meet the main goal of a late-stage trial in patients with
unresectable hepatocellular carcinoma (HCC). "The data from SEARCH showed that
the addition of Tarceva to Nexavar did not provide additional benefit to
patients with unresectable HCC," remarked Dimitris Voliotis, vice president of
global clinical development oncology at Bayer.
The SEARCH study randomised 720 patients with advanced liver cancer to
receive treatment with Nexavar twice daily, either in combination with Tarceva
once daily or placebo. Results demonstrated that the addition of Tarceva to
Nexavar did not improve overall survival compared to Nexavar alone. The
companies noted that data from the trial will be presented at a future medical
meeting.
Nexavar, which is being jointly developed by Bayer and Onyx, is approved in
the US and other countries for the treatment of patients with unresectable HCC
and for the treatment of patients with advanced renal cell carcinoma. Tarceva is
used to treat lung cancer and is co-marketed by Astellas and Roche's Genentech
unit.
Analysts at Cheuvreux said the study results were a small negative for Bayer,
but they left peak sales forecasts for Nexavar unchanged at 971 million euros
($1.2 billion) in 2019. Meanwhile, a spokesman for Roche noted while the company
provided financial support as well as Tarceva for the trial, it did not have a
development plan for the drug in liver cancer, either alone or as part of a
combination.
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