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Clinical trial results show Abraxane extends advanced pancreatic cancer survival

23 January 2013

The drug Abraxane has shown promising results in a stage III clinical trial, extending the overall survival of pancreatic cancer patients by two months, when combined with chemotherapy.

The trial, run by the US biopharmaceutical company, Celegene Corp, involved 861 participants and aimed to compare the effectiveness of Abraxane used in conjunction with gemcitabine chemotherapy against chemotherapy alone. Patients in the study had the most advanced form of the disease, in which the cancer had already spread to other organs, such as the liver and lungs.

Results showed that patients lived on average two months longer using the combination approach, with 35 per cent of these patients surviving for one year, compared to only 22 per cent who underwent only chemotherapy – an increase of 59 per cent.  In addition, the combination approach significantly increased the percentage of those who survived with the disease for up to two years, from 4 to 9 per cent.

Abraxane was licensed in the US in 2005 for use in treating breast cancer and last year it was approved for use among patients with lung cancer who could not receive radiation therapy or curative therapy. The drug is also undergoing trials to see if it is a viable treatment for melanoma as well as cancers of the bladder and ovaries.

Speaking to news agency Reuters, the study's lead investigator, Dr Daniel Von Hoff, of the Translational Genomics Research Institute in Phoenix, Arizona, said: "It's such a tough disease that moving the needle on survival at all is a major accomplishment.”   

Announcing the study results at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco last week, Dr Von Hoff noted this was the first study in such advanced pancreatic cancer to report two-year survivors.

"It's been a pretty tough, discouraging area," he said. "I'm glad to see we've got something that has an impact on survival.”

Dr Von Hoff also said that if people can live for 24 months with the disease, Abraxane might enable them to survive until better options evolve: "People will look at it and say, 'I have more of a chance than I thought'.” He also characterised the side effect profile of the combination therapy as “acceptable and manageable”.

Celegene’s executive vice president of global oncology clinical research, Jean-Pierre Bizzari MD, said:  "As the largest phase III real-world clinical trial in advanced pancreatic cancer, the clinically meaningful findings seen across key study endpoints and patient subgroups are a reflection of our ongoing commitment to develop innovative new therapies in critical areas of need."

Celegene announced that it would be filing applications in the US and Europe in the first half of 2013 seeking a licence to use Abraxane for pancreatic cancer.

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