Glaxo says lung cancer vaccine study encouraging
An experimental GlaxoSmithKline Plc vaccine showed promise in a mid-stage trial for preventing a recurrence of lung cancer and will be tested in larger studies starting early in 2007, the company said on Sunday.
Dozens of drug makers are trying to develop vaccines for patients who already have developed cancer, rather than preventing illness as traditional vaccines do.
Sometimes called “therapeutic vaccines,” most still are in early stages of research and several have suffered setbacks.
London-based Glaxo said its study showed the concept of priming the immune system to attack tumors could be a worthwhile strategy.
Interim results found 30 percent of vaccine-treated patients had their cancer return within about 21 months, compared with 42 percent of patients who got a placebo injection.
The finding did not reach statistical significance, which means it could have been due to chance.
“Although the observed 33 percent reduction in relative risk of cancer recurrence did not meet statistical significance at this interim stage ... the trend is very encouraging and warrants continued investigation,” a Glaxo statement said.
The study’s lead author said a larger study would proceed based on the positive signs seen in the trial.
“It was an exploration of a new strategy ... we have a clear signal, which is very exciting,” Dr. Johan Vansteenkiste, a respiratory oncologist at University Hospital Gasthuisberg in Belgium, said in an interview.
Vansteenkiste presented the findings at the annual meeting of the American Society of Clinical Oncology.
In the study, researchers randomly assigned 182 patients to receive injections of the Glaxo vaccine, called MAGE-3, or a placebo shot. All patients had early-stage non-small cell lung cancer, the most common form, and their tumors had been surgically removed.
Their tumors also tested positive for the MAGE-3 antigen, a substance the vaccine targets. The MAGE-3 antigen is found in about 35 percent to 50 percent of non-small cell lung cancers, Glaxo said.
Patients received 13 injections, with the first five given at three-week intervals. The next eight were given once every three months.
The most common side effects reported were mild reactions within 24 hours of the injection, the company said. Two patients dropped out of the study because of problems that may have been related to the treatment, Glaxo said.
Vansteenkiste said one of the patients who withdrew had a local reaction at the injection site. The other experienced worsening of chronic lung disease. Vansteenkiste said it was “rather unlikely” the latter problem was linked to the Glaxo product.
Phase III studies of the MAGE-3 vaccine are planned to begin in early 2007, Glaxo said.
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