Jan. 13, 2010 (Coronado, Calif.) -- A new lung cancer drug that disrupts blood vessels within the tumor and inhibits blood flow to it looks promising, say researchers who are slated to report their findings Thursday at a cancer meeting in California.
When added to traditional chemotherapy, the new drug, called vadimezan and also known as ASA404 or DMXAA, extended survival time, says Mark McKeage, PhD, an associate professor in clinical pharmacology at the University of Auckland, New Zealand, who is presenting the findings at the American Association for Cancer Research -- International Association for the Study of Lung Cancer meeting in Coronado, Calif.
"Overall survival was improved numerically from a median of 8.8 to 14 months (half lived longer, half less)," McKeage tells WebMD. ''The safety profile is favorable.''
In the phase II study, McKeage and his colleagues evaluated 108 patients who had advanced (stage IIIb or IV) non-small-cell lung cancer, the most common type of lung cancer. They assessed 104 of them for the safety evaluation and 100 to compare survival differences. Non-small-cell lung cancer is further divided into squamous cell carcinoma (cancer that originates from squamous cells, which are cells that line the airways) and non-squamous cell carcinoma, which includes other cell types.
Patients received either standard chemotherapy or chemo plus the new drug. Two different doses of the new drug were tried, McKeage says.
Lung Cancer Drug: Study Results
Giving patients the drug in addition to chemo didn't increase the toxicity of the chemo, McKeage found, and survival was greater with the combined approach at either dose.
When McKeage looked at those with squamous cancers, survival was 10.2 months in those who got the drug plus the chemo, compared with 5.5 months in those who received chemo alone.
For patients with non-squamous cancers, survival was 14.9 months with the combination therapy but 11 months on chemo alone.
"The range in survival is from a few weeks up to over a year, 18 months," he says. "One of these people is still alive, disease free, over four years after treatment. This patient had a fantastic response and then went [on] and had surgery [for the cancer]."
The most commonly reported side effects were blood and lymphatic disorders, reported by about 18%, but no serious adverse events were reported with lung hemorrhage or bleeding, a side effect that has accompanied other lung cancer drug therapy, McKeage says. The improvement is encouraging and warrants further investigation by proceeding to the phase III trial, he says.
McKeage was the principal investigator for the study, which was funded by Antisoma, who later licensed the drug to Novartis Pharmaceuticals Corp. McKeage has consulted for both companies and received research funds from both.
Vadimezan works in a different way than another cancer drug that focuses on blood vessels, Avastin, McKeage says. They compare favorably, but vadimezan has fewer side effects.
Recruitment for the phase III study is complete, he says. He predicts the new drug may be on the market by 2012 or so.
''One of the important points of this analysis is that it shows the efficacy and safety profile [of the drug] was similar in squamous and non-squamous patients,'' McKeage says.
Lung Cancer Drug: Second Opinion
The results of the vadimezan study represent "a considerable improvement in survival," says Paul A. Bunn Jr., MD, professor of medicine, James Dudley Chair in Cancer Research at the University of Colorado, Denver, and executive director of the International Association for the Study of Lung Cancer.
"Almost every year now, we are getting [new] drugs that improve survival in lung cancer patients." However, he adds, "we have a long way to go."
In the U.S., about 219,000 new cases of lung cancer were expected to be diagnosed in 2009, with 159,000 expected deaths from the disease, according to American Cancer Society estimates. Survival rates depend on the stage, with the five-year survival rate for stage IV non-small-cell lung cancer just 1%, according to the society.