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Bayer’s Nexavar fails in another lung cancer study

Dents prospects for approval in extra indication

Bayer research centre in Berlin, Germany

The prospects for Bayer and partner Onyx Pharmaceuticals' Nexavar in non-small cell lung cancer have been diminished further by its failure in another late-stage study.

A phase III trial of Nexavar (sorafenib) in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease had progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival.

The results of the 700-patient MISSION study did however suggest that Nexavar was able to improve progression-free survival (PFS) in these patients when compared to placebo.

The results echo the findings of an earlier phase III study, called NExUS, which was reported in 2010 and failed to show efficacy for Nexavar as a first-line treatment for patients with advanced NSCLC. That study investigated Nexavar versus placebo in combination with two chemotherapies, gemcitabine and cisplatin.

Ahead of the NExUS data, Bayer had said that approval in NSCLC could add up to €750m a year to Nexavar's sales, but expectations of success in lung cancer have been low, give that other drugs in the oral VEGF inhibitor class have also struggled to make an impact in the disease.

Pfizer's Sutent (sunitinib) failed to improve survival but did increase PFS in the SUN 1087 trial, which looked at the drug in in combination with Roche/Genentech's anti-EGF therapy Tarceva (erlotinib), which is already approved to treat NSCLC.

Meanwhile, Amgen/Takeda's investigational VEGF inhibitor motesanib also failed to extend survival in the phase III MONET1 trial, which compared the drug in combination with chemotherapy as a first-line regimen in NSCLC.

“While we are disappointed that the primary endpoint was not met, we believe the [MISSION] study results will advance the scientific knowledge in lung cancer," said Dr Dimitris Voliotis, Bayer's vice president of global clinical development for oncology.

Last year Nexavar brought in €725m from its approved indications in kidney and liver cancers.

22nd May 2012

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