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Phase 3 Trial of Sorafenib in Patients With Non-Small-Cell Lung Cancer Halted

LEVERKUSEN, GERMANY -- February 19, 2008 -- A phase 3 trial evaluating sorafenib (Nexavar) in patients with non-small-cell lung cancer (NSCLC) was stopped early following a planned interim analysis. The independent Data Monitoring Committee (DMC) concluded that the study would not meet its primary endpoint of improved overall survival.

The phase 3 ESCAPE (Evaluation of Sorafenib, Carboplatin and Paclitaxel Efficacy in NSCLC) trial evaluated sorafenib, an oral agent, in combination with carboplatin and paclitaxel in patients with NSCLC. Safety events were generally consistent with those previously reported. However, in the subset of patients with squamous cell carcinoma treated with sorafenib and carboplatin and paclitaxel, a higher mortality was observed versus those treated with carboplatin and paclitaxel alone.

This multicenter, randomized, double-blind, placebo-controlled study enrolled more than 900 patients with NSCLC at more than 140 clinical sites in North America, South America, Europe and the Asia Pacific region. All participating patients were naïve to any prior systemic anti-cancer treatment for their lung cancer, and enrolment was open to patients with all histologies of NSCLC, including those with squamous cell carcinoma or adenocarcinomas.

Patients were randomized to receive sorafenib 400 mg twice daily or placebo, in addition to carboplatin and paclitaxel, for up to 6 cycles. Patients then continued in a maintenance phase with single-agent sorafenib or placebo until study drug was discontinued due to tumour progression or side effects.

Sorafenib targets both the tumour cell and tumour vasculature. In preclinical studies, sorafenib has been shown to target members of two classes of kinases known to be involved in both cell proliferation and angiogenesis. These kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3 and RET.

Sorafenib is currently approved in more than 30 countries for liver cancer and in more than 60 countries for the treatment of patients with advanced kidney cancer, including the United States and the European Union. In Europe, sorafenib is approved for the treatment of hepatocellular carcinoma and for the treatment of patients with advanced renal cell carcinoma (RCC) who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Sorafenib is also being evaluated by the companies, international study groups, government agencies and individual investigators as a single agent or combination treatment in a wide range of other cancers, including metastatic melanoma, breast cancer and as an adjuvant therapy for kidney cancer and liver cancer.

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. are providing information regarding the DMC recommendation to halt the NSCLC study to health authorities and those clinical investigators involved in studies of sorafenib. In addition, the companies will further review the findings of this analysis and DMC recommendation to determine what, if any, impact they have on other ongoing sorafenib lung cancer trials. Data from this study will be presented at an upcoming scientific meeting.

"While we are disappointed in this outcome, Bayer and Onyx remain committed to our comprehensive pan-tumour clinical trial program for [sorafenib]. [Sorafenib] has proven significant clinical benefit for patients with liver cancer and advanced kidney cancer and we will continue to investigate its potential across a wide variety of tumours," said Susan Kelley, MD, vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals.


Source: Bayer HealthCare Pharmaceuticals

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