Bayer and partner Onyx Pharmaceuticals have been boosted by data from a mid-stage trial which revealed that Nexavar in combination with Roche’s chemotherapy Xeloda extended progression-free survival in patients with advanced breast cancer, compared to capecitabine and placebo.
The Phase II study involved 229 patients with locally advanced or metastatic HER-2 negative breast cancer who had received no more than one prior chemotherapy, and who were given either Nexavar (sorafenib) or placebo twice daily, plus treatment with Xeloda (capecitabine). These results in favour of the Nexavar/Xeloda combo were statistically significant and the companies said that full results will be presented at an upcoming scientific meeting.
Jose Baselga, professor of medicine at Vall d’Hebron Institute of Oncology in Barcelona and the principal investigator of the study, said the results represent “a positive signal of the benefit of this combination for patients with advanced breast cancer and is the first statistical demonstration of efficacy for a multi-tyrosine kinase inhibitor in this disease”. He added that “one goal of this study was to evaluate the success of an all oral regimen, which may represent a unique treatment option for patients with breast cancer”.
Analysts were split on the importance of the news, with Eric Schmidt at Cowen & Co saying that “our enthusiasm is somewhat tempered” because the duration of benefit is not known yet. However, Christopher Raymond at Robert W Baird issued a note saying that Nexavar, which is already approved to treat kidney and liver cancers, is “a possible game changer” in breast cancer, because of these latest “robust” results.
The news certainly went down well with investors in Onyx and the company’s shares climbed more than 24%.
NICE looks at Nexavar again
Meantime, Bayer noted that the National Institute for Health and Clinical Excellence in the UK is to discuss the benefits of the drug again for liver cancer patients on August 12. The agency has received new information from the company regarding pricing and will review it again, having said in a preliminary recommendation in May that the drug should not be made available on the National Health Service.
Bayer said it is “encouraged that NICE has delayed its decision to issue final guidance for Nexavar,” and it hopes that it “takes this opportunity to evaluate and fully understand the benefit of our proposed patient access scheme”.
