Abraxane extends life in advanced pancreatic cancer patients

Abraxane is shaping up to improve treatment for patients with advanced pancreatic cancer, with phase III trial results released today showing it improves survival when combined with gemcitabine.

Abraxane was developed by US biotech Celgene and is distributed in Australia by Specialised Therapeutics Australia.

It is a solvent-free nanoparticle using Celgene's nab technology, which coats the chemotherapy drug paclitaxel with albumin, lending the drug greater solubility, eliminating the need for solvents during administration.

The technology reportedly allows Abraxane to deliver a nearly 50% higher dose compared to regular paclitaxel without compromising safety and tolerability.

It is currently approved for use against metastatic breast cancer in over 40 countries and has been granted orphan drug status by the Therapeutic Goods Administration for the treatment of pancreatic cancer.

The trial involved 861 individuals and found that patients treated Abraxane combined with gemcitabine had a statistically significant improvement in survival compared to patients receiving gamcitabine alone, with the combined treatment extending life from a median of 6.7 months to 8.5 months.

Abraxane plus gemcitabine also demonstrated a 59% increase in one-year survival and demonstrated double the rate of survival at two years as compared to gemcitabine alone.

The combined treatment also demonstrated statistically significant improvements in secondary endpoints compared to gemcitabine alone, including a 31% reduction in the risk of progression or death with a median progression-free survival and an overall response rate (ORR) of 23% compared to 7%.

Another endpoint assessed was time to treatment failure, which was significantly improved with the Abraxane combination compared to gemcitabine alone.

Side-effects reported included an increase in neutropenia, fatigue and neuropathy compared to gemcitabine alone. Those who received Abraxane had a median time to neuropathy improvement of 29 days.

Advanced pancreatic cancer is one of the most difficult to treat, so the results represent a substantial improvement over the current standard of care.

"The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer, which is both deadly and incredibly difficult to treat with success," said Dr Daniel D. Von Hoff, Lead Principal Investigator of the study and Chief Scientific Officer for Scottsdale Healthcare's Virginia G. Piper Cancer Centre Clinical Trials and Physician-In-Chief for TGen.

"The fact that Abraxane plus gemcitabine demonstrated an overall survival benefit, and also did so at one and two years, is a significant step forward in offering potential new hope for our patients."

Professor John Zalcberg, Chief Medical Officer and Executive Director of Cancer Medicine at the Peter MacCallum Cancer Centre in Melbourne, said the evidence strongly supported using Abraxane in combination with gemcitabine as a new standard of care to treat appropriate patients, many of whom were not diagnosed until the disease was metastatic.

"We are extremely encouraged by the results of this study involving Abraxane and regard this outcome as a significant breakthrough in terms of the future management of this disease," he said.

"In addition to treating women with metastatic breast cancer with Abraxane in the appropriate setting, we look forward to its approval in Australia for treating patients with advanced pancreatic cancer."

Specialised Therapeutics Australia is aiming to have Abraxane approved by the TGA for use against advanced pancreatic cancer in the latter half of 2014.

The results of the clinical trial will be presented on 25th January at the American Society of Clinical Oncology's (ASCO) 2013 Gastrointestinal Cancers Symposium in San Francisco