Just after staff at the US Food and Drug Administration made positive noises about expanding the label on Xarelto, one of Bayer's other key drugs, Nexavar, has failed in a late-stage lung cancer trial.
The German group has announced that a Phase III trial evaluating Nexavar (sorafenib) in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival. However, an improvement in the secondary endpoint of progression-free survival was observed.
The trial, which was conducted at more than 150 sites, randomised 703 patients to receive either Nexavar as single agent or placebo, plus best supportive care for both arms. The safety and tolerability data were generally as expected, Bayer and partner Onyx Pharmaceuticals noted, adding that the full set of results will be presented at an upcoming scientific meeting.
Dimitris Voliotis, head of global clinical development oncology at Bayer HealthCare, said that "while we are disappointed that the primary endpoint was not met, we believe the study results will advance the scientific knowledge in lung cancer". Nexavar, which is approved for liver and kidney cancer, is a big-seller for Bayer and first-quarter revenues came in at 186 million euros, up 4.5%.
Xarelto recommended for ACS by FDA staff
However the Leverkusen-headquartered firm believes the anticoagulant Xarelto (rivaroxaban) will be its key earnings driver for the next decade, and those hopes have been boosted by documents released ahead of an FDA advisory committee meeting tomorrow (May 23).
Bayer and US partner Johnson & Johnson are seeking expanded approval to market Xarelto as a treatment for acute coronary syndrome. It is already available for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation and to prevent venous thromboembolism in patients undergoing knee or hip surgery.
FDA reviewer Karen Hicks recommended approving the drug for ACS, saying that "overall, the benefit-risk ratio for Xarelto appears to be favourable, predominantly because there is a reduction in cardiovascular death". However, she highlighted the increased risk of major and fatal bleeding, saying this "may represent the biggest problem for both patients and health care providers".
Furthermore, over 15% of patients enrolled in the 15,00-patient ACS study dropped out so questions about the lack of follow-up on those patients are likely to be raised at the panel meeting.
