Celgene’s Abraxane increases survival in pancreatic cancer

The survival extension seen in the Abraxane study is likely to be viewed by regulators as clinically meaningful and result in an expanded approval and a significant sales boost for Abraxane.

The drug had sales of $106 million in the third quarter of 2012. Celgene has targeted Abraxane sales of $1 billion to $1.25 billion in 2015, reaching as high as $2 billion in 2017, helped by use of the drug against pancreatic cancer and melanoma.

Abraxane also met secondary goals of the study. It demonstrated an improvement in a median progression-free survival, or the time it took for the disease to worsen, at 5.5 months versus 3.7 months, and had an overall response rate, or those who experienced tumor shrinkage, of 23 percent compared with 7 percent in the control group.

Time to treatment failure was also improved with Abraxane plus gemcitabine, Celgene said.

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.

Pancreatic cancer survival by stage

Survival rates are often used by doctors as a standard way of discussing a person’s prognosis (outlook). Some patients with pancreatic cancer may want to know the survival statistics for people in similar situations, while others may not find the numbers helpful, or may even not want to know them. If you decide you do not want to know them, stop reading here and skip to the next section.

The 5-year survival rate refers to the percentage of patients who live at least 5 years after their cancer is diagnosed. Of course, many people live much longer than 5 years (and many are cured).

In order to get 5-year survival rates, doctors have to look at people who were treated at least 5 years ago. Improvements in treatment since then may result in a more favorable outlook for people now being diagnosed with cancer of the pancreas.

Survival rates are often based on previous outcomes of large numbers of people who had the disease, but they cannot predict what will happen in any particular person’s case. Many other factors can affect a person’s outlook, such as the patient’s overall health, what treatments are given, and how well the cancer responds to treatment. Your doctor can tell you how the numbers below may apply to you, as he or she is familiar with the aspects of your particular situation.

The numbers below come from the National Cancer Data Base and are based on people diagnosed with exocrine cancer of the pancreas between 1992 and 1998.

Von Hoff characterized the side effect profile of the combination therapy as “acceptable and manageable.”

Deaths connected to adverse events were 4 percent in both arms of the study.

There was a significantly higher incidence of peripheral neuropathy, a numbness in the fingers or toes, seen in the Abraxane group, at 17 percent versus less than 1 percent in the control group, researchers said.

“One thing we worry about is febrile neutropenia,” or a low white blood cell count with fever, Von Hoff said. The incidence was 3 percent for the Abraxane combination and 1 percent for gemcitabine. “That is very comforting,” he said.

“I’m glad to see we’ve got something that has an impact on survival,” Von Hoff said. “It’s something to build on.”

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By Bill Berkrot
Reuters

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