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Nexavar fails late-stage breast cancer trial

Bayer’s oncology drug unable to improve progression free survival in new indication
Bayer Nexavar sorafenib

Efforts by Bayer and Amgen subsidiary Onyx to expand the indications of their cancer drug Nexavar into breast cancer have hit the buffers.

The results of a phase III trial called RESILIENCE showed that Nexavar (sorafenib) given in combination with capecitabine was unable to improve progression-free survival (PFS) compared to capecitabine plus placebo in patients with advanced breast cancer.

The trial enrolled patients with HER2-negative breast cancer who had failed or were unable to receive prior taxane- and anthracycline-based chemotherapy.

Bayer's head of global development Joerg Moeller said he was disappointed with the outcome of the study, as patients in this group have relatively few treatment options left.

Nexavar is one of Bayer's fastest-growing products, with sales rising 40 per cent in the first quarter of the year from its current use in hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC) and most recently radioactive iodine-refractory thyroid cancer, an indication approved in the US last year.

Bayer, Onyx and their clinical partners also have phase III trials of Nexavar ongoing in adjuvant (post-surgery) treatment of RCC, as well as an early-stage study in pre-surgical RCC patients, as well as various other solid tumour types including melanoma, glioma and head and neck cancer.

In addition to the breast cancer disappointment, Nexavar also fell short in an adjuvant HCC study earlier this year after failing to show any improvement in PFS compared to placebo, and was also ineffective in a phase III lung cancer trial in 2012.

The drug is already making more than $1bn a year in sales - despite intense competition from the likes of Pfizer's Sutent (sunitinib) and Inlyta (axitinib), Novartis' Afinitor (everolimus) and GlaxoSmithKline's Votrient (pazopanib) - but without the breast cancer indication could struggle to meet analyst targets of around $1.5bn by 2018.

Sorafenib blocks the enzyme RAF kinase, part of the RAF/MEK/ERK signalling pathway that controls cell division and proliferation, while also inhibiting the VEGFR-2/PDGFR-beta signalling cascade.

25th July 2014

From: Research

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