In the phase III MAGRIT trial reported in The Lancet Oncology, Vansteenkiste et al found that adjuvant therapy with the MAGE-A3 cancer immunotherapeutic did not improve disease-free survival in patients with resected MAGE-A3–positive non–small cell lung cancer (NSCLC). The immunotherapeutic combines a tumor-specific antigen (recombinant MAGE-A3 protein) with an immunostimulant (AS15).
In the double-blind trial, 2,272 patients from 443 sites in 34 countries with completely resected stage IB, II, or IIIA MAGE-A3–positive disease who did or did not receive adjuvant chemotherapy were randomized 2:1 between October 2007 and July 2012 to receive 13 intramuscular injections of MAGE-A3 (n = 1,515) or placebo (n = 757) over 27 months. Chemotherapy was received by 784 patients in the MAGE-A3 group and 392 in the placebo group. The primary endpoints included disease-free survival in all patients and in those not receiving chemotherapy.
Median follow-up was 38.1 months in the MAGE-A3 group and 39.5 months in the placebo group. Among all patients, median disease-free survival was 60.5 months vs 57.9 months (hazard ratio [HR] = 1.02, P = .74). Among patients who did not receive chemotherapy, median disease-free survival was 58.0 vs 56.9 months (HR = 0.97, P = .76). Among those who did receive chemotherapy, median disease-free survival was 60.5 months vs not reached (HR = 1.10, P = .36). Due to the absence of treatment effect, no gene signature predictive of benefit of the MAGE-A3 immunotherapeutic could be identified.
Grade ≥ 3 adverse events occurred in 16% of the MAGE-A3 group and 16% of the placebo group, with the most common being infection (2% vs 3%), vascular disorders (2% vs 3%), and neoplasms (2% vs 2%).
The investigators concluded: “Adjuvant treatment with the MAGE-A3 immunotherapeutic did not increase disease-free survival compared with placebo in patients with MAGE-A3-positive surgically resected NSCLC. Based on our results, further development of the MAGE-A3 immunotherapeutic for use in NSCLC has been stopped.”
The study was funded by GlaxoSmithKline Biologicals SA.
Johan F. Vansteenkiste, MD, of the University Hospital KU Leuven, is the corresponding author of The Lancet Oncology article.
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