Bayer and Onyx Pharmaceuticals announced Aug. 27 that a trial evaluating Nexavar (sorafenib) in Asia-Pacific patients with hepatocellular carcinoma will be stopped early to allow all patients to receive the drug based on positive study results and the recommendation of an independent data monitoring committee.

The Phase III study showed that treatment with Nexavar significantly improved overall survival, progression-free survival and time-to-progression in patients with advanced stages of the disease.

The trial was conducted at the request of Asian drug regulators to provide supplemental data on the safety and efficacy of Nexavar in Asia-Pacific patient populations.

Bayer and Onyx have already filed supplementary regulatory filings seeking approval of Nexavar for the liver cancer indication in the U.S., EU and China. Bayer and Onyx announced the submission of an sNDA for liver cancer in the U.S. in June (¹ Also see "Bayer/Onyx Submit Nexavar sNDA For Liver Cancer" - Pink Sheet, 27 June, 2007.). Emeryville, Calif.-based Onyx has said it expects to launch Nexavar for kidney cancer "early next year."

The oral multi-kinase inhibitor was approved for the treatment of advanced kidney cancer in December 2005 (² Also see "Bayer/Onyx’ Nexavar Approved For Kidney Cancer" - Pink Sheet, 20 December, 2005.).

The drug could be the first FDA-approved therapy to significantly extend survival in patients with HCC. Results of the pivotal SHARP study showed that treatment extended overall survival in patients by 44 percent over placebo.

The Asia-Pacific study was a double-blind, randomized, placebo-controlled trial evaluating Nexavar in patients with advanced HCC who had no prior systemic therapy. The study enrolled 226 patients in China, Korea and Taiwan, comparing overall survival TTP and PFS in patients administered Nexavar 400 mg twice daily compared to patients on placebo. Results of the study will be presented at an upcoming medical meeting.

The companies have also announced plans to conduct a Phase III study evaluating Nexavar in the adjuvant treatment of HCC following complete removal of early stage liver disease.

In an Aug. 27 research note, Bear Stearns analyst Akhtar Samad said, "While we believe these results are a clear positive for Onyx, we are maintaining our worldwide Nexavar estimates of $326 million in 2007, $526 million in 2008 and peak sales estimates of roughly $925 million in the 2010 timeframe."

Approval in China would represent upside to the sales projections, he predicted, since the estimates are based solely on sales in Japan.

- Jessica Merrill (j.merrill@elsevier.com)

This article is reprinted from "The Pink Sheet" DAILY, August 28, 2007

Nexavar Survival Study In Asia-Pacific Patients With Liver Cancer Halted Early

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