Celgene Corp said its Abraxane drug helped patients with advanced pancreatic cancer live an average of two months longer than chemotherapy and significantly increased the percentage of those who survived with the disease for up to two years, according to a late-stage study.
Based on the results, Celgene said it expects to file applications in the United States and Europe in the first half of this year seeking approval for the use of Abraxane for pancreatic cancer.
Celgene previously said Abraxane met the main survival goals of the study of 861 patients who had not previously been treated for their cancer. It released the details on Tuesday ahead of a medical meeting where the study will be presented this week.
Patients who received Abraxane in combination with the chemotherapy agent gemcitabine had a median overall survival of 8.5 months, compared with 6.7 months for patients who received standard therapy of gemcitabine alone. The result was deemed to be statistically significant, researchers said.
“It’s such a tough disease that moving the needle on survival at all is a major accomplishment,” Dr. Daniel Von Hoff, the study’s lead investigator, said in a telephone interview.
“It’s been a pretty tough, discouraging area,” he said, adding that the overwhelming majority of studies of similar patients have failed to improve survival at all.
Abraxane plus gemcitabine demonstrated a 59 percent increase in one-year survival - 35 percent vs 22 percent - and doubled the rate of survival at two years from the start of treatment, with 9 percent still alive compared with 4 percent for gemcitabine alone.
One-, five- and ten-year survival statistics for pancreatic cancer by age and trends over time are presented here. There are also data by geography and by stage at diagnosis. The ICD code for pancreatic cancer is ICD-10 C25.
The statistics on these pages give an overall picture of survival. Unless otherwise stated, the statistics include all adults diagnosed with pancreatic cancer, at all ages, stages and co-morbidities. The survival time experienced by an individual patient may be much higher or lower, depending on specific patient and tumour characteristics. If you are a patient, you will probably find our CancerHelp pages more relevant and useful.
The latest survival statistics available for pancreatic cancer in England are 2005-2009 (followed up to 2010).
The most recent five-year survival data for 1995-1999 show England, Scotland and Northern Ireland are slightly below the average for Europe (5%), while Wales is around the European average. Across the European countries, five-year survival rates range from 2% to 9%. However, as with international incidence estimates, differing data collection practices throughout Europe may contribute to the ranking of individual countries.
Von Hoff said this was the first study in such advanced pancreatic cancer to report two-year survivors.
“People will look at it and say, ‘I have more of a chance than I thought,’” he said. He added that if people can live for 24 months with the disease, Abraxane might enable them to survive until better options evolve.
“It gives you more of a chance to get to hopefully a real breakthrough,” said Von Hoff. “You just don’t know what’s coming.”
He will present the data on Friday at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco.
Pancreatic Cancer Survival Improves By Over 60% With Combination Of Four Drugs
Patients with pancreatic cancer who take a combination of four chemotherapy medications were found to have 60% better average survival, French scientists reported in NEJM (New England Journal of Medicine). Despite having to endure several side effects, the scientists informed that the quality of life of the survivors was not badly affected.
Pancreatic cancer has an extremely high death rate. For this reason, patients are more likely to willingly endure chemotherapy side effects in order to live a few months longer.
Of the approximately 43,000 people who are diagnosed with pancreatic cancer in the USA annually, 36,800 of them die from it. Pancreatic cancer represents only 2.5% of all cancer cases in America, but is the fourth leading cause of cancer death in the country. Fewer than 6% of patients survive for longer than five years after diagnosis.
Dr. Thierry Conroy of Nancy University and Centre Alexis Vautrin, Nancy, France, performed a Phase III trial - known as PRODIGE 4/ACCORD 11 - on 342 patients with pancreatic cancer. Half of them were randomly selected to receive FOLFIRINOX (made up of four drugs: oxaliplatin, irinotecan, leucovorin and fluorouracil), while the other half received Gemzar (gemcitabine), the first line drug used for pancreatic cancer therapy. They were all under seventy-six years of age and received their medications for six months.
Abraxane is already approved to treat breast and lung cancer and has also demonstrated efficacy against melanoma.
Advanced pancreatic cancer has the lowest survival rate among all cancer types, with a five-year survival rate of less than 2 percent. With few recent advances in the field, it remains one of the most critical unmet needs in oncology.