Adjuvant therapy with the MAGE-A3 immunotherapeutic did not prolong disease-free survival compared with placebo in patients with MAGE-A3-positive surgically resected non-small cell lung cancer (NSCLC), a study published in the journal The Lancet Oncology has shown.1
Because minimal progress has been made in adjuvant chemotherapy for patients with NSCLC since its introduction in 2004, researchers sought to evaluate the efficacy of the MAGE-A3 cancer immunotherapeutic in patients with resected NSCLC.
For the double-blind, placebo-controlled, phase 3 trial, investigators enrolled 2312 patients with completely resected stage IB, II, or IIIA MAGE-A3-positive NSCLC who had or had not received prior adjuvant chemotherapy. Participants were randomly assigned 2:1 to receive recMAGE-A3 with AS15 immunostimulant (MAGE-A3 immunotherapeutic) or placebo over a period of 27 months. About half of all patients in each arm also received chemotherapy.
Results showed that at a median follow-up of 38.1 months in the MAGE-A3 group and 39.5 months in the placebo group, median disease-free survival was 60.5 months (95% CI, 57.2-not reached [NR]) and 57.9 months (95% CI, 55.7-NR), respectively (hazard ratio [HR], 1.02; 95% CI, 0.89-1.18; P = .74).
Of those that received chemotherapy, median disease-free survival was 58.0 months (95% CI, 56.6-NR) in the MAGE-A3 treatment arm compared with 56.9 months (95% CI, 44.4-NR) in the placebo arm (HR, 0.97; 95% CI, 0.80-1.18; P = .76).
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In regard to safety, 16% of patients in the immunotherapy group and 16% of those in the placebo group reported grade 3 or higher adverse events. The most common grade 3 or higher adverse events in the MAGE-A3 group were infections and infestations, vascular disorders, and neoplasm.
Based on these findings, further development of the MAGE-A3 immunotherapeutic for treatment of NSCLC has been terminated.
- Vansteenkiste JF, Cho BC, Vanakesa T, et al. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial [published online ahead of print April 27, 2016]. Lancet Oncol. doi: 10.1016/S1470-2045(16)00099-1.