Nexavar fails in melanoma study
pharmafile | April 30, 2009 | News story | Research and Development | Bayer, Cancer, Nexavar
Onyx Pharmaceuticals and its development partner Bayer have stopped a phase II trial of Nexavar in patients with late-stage melanoma, citing a lack of efficacy.
The independent committee overseeing the study concluded that adding Nexavar (sorafenib) to a chemotherapeutic regimen of paclitaxel and carboplatin does not confer any improvement in overall survival compared to the chemotherapy regimen plus placebo.
As a result Onyx and Bayer have decided to terminate the study, dashing the hopes of late-stage (stage III or IV) melanoma patients who have very few treatment options and only hope of a handful of new drugs coming through development.
The companies said they now intend to analyse the data to see what the impact the results will have on "other ongoing Nexavar melanoma trials".
Nexavar is already on the market for liver and kidney cancer, and saw its sales grow 82% last year to $678 million in 2008. Onyx said in February it thought revenues would reach up to $875m this year and cross the $1 billion threshold in 2010 and has not changed these forecasts in light of the melanoma trial disappointment.
Onyx and Bayer were forced to discontinue another Nexavar trial in melanoma in December 2006 after concluding that it was unable to improve progression-free survival when added to a regimen of carboplatin and paclitaxel.
The following February the partners also conceded defeat and stopped a phase III trial of the drug in non-small cell lung cancer, once again because it was unable to confer a survival benefit.
Melanoma accounts for about 4% of skin cancer cases, but is responsible for approximately 77% of skin cancer deaths. Efforts to develop an effective therapy for the disease have proved very difficult, with a long and growing list of compounds which failed in the clinic despite early promise.
Just this week Sanofi-Aventis said it had abandoned development of a therapeutic vaccine for melanoma, which had reached phase II trials, as part of an overhaul of its R&D portfolio.
Meanwhile other candidates remain in development but are facing obstacles. For example, GlaxoSmithKline is testing its MAGE-A3 immunotherapeutic for melanoma in phase III trials, but a pivotal trial of another compound partnered with Synta – elesclomol – was discontinued on safety concerns in February 2009.
Another melanoma candidate is Genta's Genasense (oblimersen sodium) which is in phase III trials. This was turned down for approval in melanoma in Europe and the US in 2007 but Genta has been conducting additional studies to try to bolster its data dossier for the drug. Genasense was also turned down in the US for another indication – chronic lymphocytic leukaemia – on the grounds that another trial would be needed to support approval.
Last year AstraZeneca stopped development of its AZD6244 in melanoma after it failed to show superiority to Schering-Plough's Temodar (temozolomide) in a phase II trial.
At the moment the brightest prospect for advanced melanoma treatment appears to be Bristol-Myers Squibb/Medarex's ipilimumab, which doubled one-year survival compared to Temodal in a phase II trial reported last year.
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