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Novartis' Afinitor sees positive trial results in breast cancer

Data indicating extended progression-free survival in women bring cancer drug closer towards new indication

Novartis moved a step close towards a lucrative breast cancer indication for its cancer drug Afinitor yesterday after reporting positive data from a phase III study.

Combination therapy based on Afinitor (everolimus) and Pfizer's anti-oestrogen drug Aromasin (exemestane) doubled progression-free survival in women with advanced breast cancer compared to Aromasin alone in the study, which presented at the San Antonio Breast Cancer Symposium.

Afinitor is already approved for advanced renal cell carcinoma and neuroendocrine tumours of pancreatic origin, but extending its indications in into breast cancer could add another 200,000 or more potential patients and $1bn to its peak sales potential. Novartis says it plans to file for approval in the new indication before the end of the year.

The drug brought in $310m for Novartis in the first nine months of the year, an 82 per cent increase over the same period of 2010.

The updated results of the BOLERO-2 study showed that Afinitor and Aromasin extended progression-free survival to 7.4 months in breast cancer patients, compared to 3.2 months with Aromasin alone.

Meanwhile, 12-month estimates of patients without disease progression were 31 per cent in the combination group and 10 per cent for Aromasin on its own.

"These data provide longer-term evidence of the benefit of adding everolimus to hormonal therapy in patients whose disease progressed while on or following initial hormonal treatment," commented Gabriel Hortobagyi of MD Anderson Cancer Centre in the US, the lead study author.

While there have been a multitude of new treatments for women with HER2-positive breast cancer in recent years, pharma pipelines have not been so generous for forms of the disease associated with other genetic mutations. BOLERO-2 enrolled patients who were HER2-negative but estrogen receptor-positive.

"Despite the significant progress in treating women with breast cancer, there have been no new treatment advances for women living with ER+HER2- advanced breast cancer in more than 15 years," said Hervé Hoppenot, president of Novartis Oncology.

"The results of BOLERO-2 are the first to show everolimus combined with hormonal therapy enabled women with this type of breast cancer to live significantly longer without their tumour progressing."

Novartis is also developing Afinitor for gastric cancer, HER2-positive breast cancer, hepatocellular carcinoma and lymphoma, and expects to file marketing applications in these indications from 2012 onwards.

9th December 2011

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