Encouraging Clinical Activity of GSK's Novel Cancer,Immunotherapeutic Confirmed in Phase II Study in Patients with Most,Common Form of Lung Cancer ( fied recombinant proteins andGSK's ow...)

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Encouraging Clinical Activity of GSK's Novel Cancer,Immunotherapeutic Confirmed in Phase II Study in Patients with Most,Common Form of Lung Cancer

fied recombinant proteins, and GSK's own proprietary Adjuvant Systems, which are specifically designed to enhance ASCIs anti-tumor activity

Phase II NSCLC Clinical Trial Results

This Phase II double-blind, placebo-controlled study is the first proof- of-concept trial for an ASCI in early NSCLC. The study randomized 182 patients with completely resected stage IB or II NSCLC to receive either MAGE-A3 ASCI or placebo as adjuvant therapy. All patients participating in the trial had cancers expressing a tumor-specific antigen known as MAGE-A3, which is present in approximately 35 percent to 50 percent of early NSCLC(1).

The final analysis was performed at a median follow-up of 28 months. At this time, 41 of the 122 patients receiving MAGE-A3 relapsed (30.6%); in comparison to 26 of the 60 patients receiving placebo (43.3%). Using a Cox regression model to adjust for the fact that patients in the different arms were enrolled in the study at different times, there was a 27% reduction in the relative risk of cancer recurrence following surgery, compared with placebo (p=0.107). Although the study was not powered to show statistical significance, the trend is encouraging and warrants continued clinical investigation of MAGE-A3 ASCI.

In the Phase II clinical study, the most commonly reported adverse events were mild local (pain, redness, swelling) or systemic (fever, fatigue, muscle pain) reactions observed within the 24 hours of injection. Out of 182 patients, one patient was withdrawn from the clinical trial due to adverse events possibly related to the MAGE-A3 treatment. Based on available results, GSK's MAGE-A3 ASCI may have the potential to be suitable for maintenance therapy delivered intra-muscularly on an outpatient basis.

Phase III Non-Small Cell Lung Cancer Trial Launch

GSK is now recruiting for a Phase III trial evaluating MAGE-A3 ASCI as adjuvant therapy in MAGE-A3 positive patients with NSCLC. With a target of about 2,270
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