New drug class shows promise

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New drug class shows promise for non-small lung cancer

Source: (cancerfacts.com)

Tuesday, June 06, 2006

ATLANTA – June 6, 2006 – A new class of drug reduced the risk of lung cancer recurrence by one-third compared to placebo after patients underwent surgery for non-small cell lung cancer.

While the preliminary result was not statistical conclusive at this early stage of the trial, it is encouraging to researchers led by Dr. Johan Vansteenkiste of University Hospital Maastricht, Netherlands, who are investigating what could become a new approach to treating the most common form of lung cancer. The results were presented yesterday at the annual meeting of the American Society of Clinical Oncologists.

The study involves a new class of drug, called Antigen Specific Cancer Immunotherapeutics (ASCI), sometimes referred to as pharmaccines or therapeutic cancer vaccines. These new compounds stimulate the patient's own immune response to selectively attack cancer.

In this study the compound tested, called MAGE-A3, was administered in combination with another compound to ensure a strong anti-tumor immune response. MAGE-A3 is an investigational drug and is only available through clinical trials at this time. It was developed by Glaxo Smith Kline Biologicals.

"These first results obtained with our MAGE-A3 ASCI reinforce our belief in the potential application of the ASCI approach in the treatment of cancer", said Jean Stéphenne, president of GSK Biologicals.

In this proof-of-concept early stage clinical trial, all the participating patients had tumors expressing a tumor-specific antigen known as MAGE-A3, which is present in approximately 35 percent to 50 percent of non-small cell lung cancer patients.

The multi-center study involved 182 early stage (stage IB or stage II) non-small cell lung cancer patients who had undergone surgery to remove lung tumors that carried the MAGE-A3 protein. Approximately half the patients received the MAGE-A3 drug and the others did not.

In this interim analysis of the study performed at a median follow-up of 21 months the results showed that 37 of the 122 patients receiving MAGE-A3 ASCI had relapsed (30.3 percent); compared to 25 of the 60 patients receiving placebo (41.7 percent). This represents a 33 percent relative reduction in risk of cancer recurrence in patients treated with MAGE-A3 ASCI compared to placebo.

Although the observed 33 percent reduction in relative risk of cancer recurrence did not meet statistical significance at this interim stage, the researchers consider the trend to be very encouraging and warrants continued investigation.

The most commonly reported side effects were mild local or systemic reactions observed within the 24 hours of injection. Out of 182 patients, 2 patients were withdrawn from the clinical trial due to adverse events that could be related to the MAGE-A3 treatment.

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