Results support further testing of GSK cancer vaccine

The results from the phase II trial for its investigational MAGE-A3 antigen-specific cancer immunotherapeutic (ASCI) in MAGE-A3 positive patients with stage IB or II non-small cell lung cancer (NSCLC) were encouraging, GSK said, and the company is initiating a phase III trial based on the data.

The phase III efficacy and safety trial for the immunotherapy will be the largest clinical study ever conducted in lung cancer treatment, said GSK. MAGE-A3 ASCI will be evaluated as adjuvant therapy in about 2,270 MAGE-A3 positive patients with completely resected stage IB, II or IIIA NSCLC.

GSK’s ASCIs aim to stimulate the patient’s own immune response to identify and attack cancer cells in a highly specific manner. 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% to 50% of early NSCLC.

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 Out of 182 patients, one patient was withdrawn from the clinical trial due to adverse events possibly related to the MAGE-A3 treatment.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.

Vincent Brichard, vice president of the ASCI Program at GSK Biologicals, said: “We believe ASCIs may mark the start of a new generation of cancer treatments, with significant potential across various cancer types.”