* 61 pct of patients progression free at 15 months
* Little added toxicity seen with addition of Avastin
By Bill Berkrot
NEW YORK, May 14 (Reuters) - Roche’s ROG.VX Avastin showed promise in delaying the the progress of brain cancer in newly diagnosed patients when it was added to current standard therapies, according to data from a mid-stage clinical study.
Avastin was recently approved to treat the most common and deadly brain tumors called glioblastoma multiforme once the disease has recurred.
The study, to be presented at the American Society of Clinical Oncology (ASCO) meeting in Orlando later this month, aimed to show Avastin used along with standard therapy at an early stage of the disease could help keep the cancer from worsening without significantly increasing toxicity.
The 125-patient, Phase II trial tested Avastin in combination with radiation therapy and Schering-Plough Corp’s SGP.N Temodar, which are commonly used to treat malignant brain tumors.
The primary goal of the study was improvement in median progression-free survival, or the time it takes for the disease to worsen, in half the patients in the trial.
“When we moved Avastin to the newly diagnosed setting and combined it with radiation and Temodar, we saw a marked improvement in progression-free survival,” said Dr James Vredenburgh, professor of medicine at Duke University and the study’s principal investigator. “It’s exciting preliminary data.”
Without a placebo control group the results cannot be deemed statistically significant, but compared with historical expectations, the addition of Avastin appears to have considerable positive impact.
At an average of 15 months of follow-up, 61 percent of patients in the trial were progression free, meaning the study had not yet reached the point of median progression-free survival.
Standard glioblastoma multiforme (GBM) treatment typically results in median progression-free survival of 6.9 months, according to background in the study summary, or abstract — less than half of what has so far been seen in the Duke- sponsored Avastin study.
ASCO released summaries on Thursday of hundreds of cancer studies that will be presented at its scientific meeting.
There was no placebo control in the trial as researchers sought to determine whether the addition of Avastin was safe enough to justify much larger studies in newly diagnosed patients.
“We were worried that, when you added Avastin to radiation, you’d have a lot of toxicity,” explained Vredenburgh, who added there was a slight increase in toxicity.
“The toxicity is far outweighed by the improvements that we’re seeing in progression-free survival. That was really critical and essential for moving on with Phase III studies.”
According to available data from the first 75 patients, 14 dropped out of the study due to toxicity and there were seven deaths, two of which were associated with the treatment, researchers said.
Swiss drugmaker Roche Holding AG gained full rights to the Genentech-developed blockbuster cancer drug, known chemically as bevacizumab, with its acquisition of the U.S. biotechnology company this year. Avastin is also approved to treat colon, lung and breast cancers.
“I think this is really going to change the survival of patients with GBM,” Vredenburgh added. (Reporting by Bill Berkrot; Editing by Andre Grenon)