Final Results of Phase II Trial of Eftilagimod Alpha in Metastatic Breast Cancer
Posted: Thursday, December 16, 2021
During the 2021 Society for Immunotherapy of Cancer (SITC) Annual Meeting (Abstract 948), Hans Wildiers, MD, PhD, of University Hospitals Leuven, Leuven, Belgium, and colleagues presented the final results of AIPAC—a phase IIb trial evaluating the combination of the soluble LAG-3 protein, eftilagimod alpha, with paclitaxel in breast cancer. These investigators suggest that although efilagimod alpha led to improved overall survival due to an increase in circulating CD4/CD8 T cells and should be further investigated in this patient population, the improvement was nonsignificant.
This placebo-controlled trial enrolled 226 patients with hormone receptor–positive, HER2-negative metastatic breast carcinoma who received endocrine-based therapy. Participants were randomly assigned to receive paclitaxel plus either eftilagimod alpha (n = 114) or placebo (n = 112) for up to 52 weeks.
Most patients (91.6%) had visceral disease, were resistant to endocrine therapy (84%), and had an Eastern Cooperative Oncology Group performance status of 0 (61.5%). The median overall survival was 20.4 months with eftilagimod alpha and 17.5 months with placebo.
According to univariate analysis, a significant overall survival improvement was observed in younger patients, those with low baseline monocytes, and/or luminal B cancer. In multivariate analysis, however, poor progression-free and overall survival were independently associated with increasing body mass index and previous CDK4/6 treatment. Notably, discontinuation of therapy because of treatment-emergent events occurred similarly among those given eftilagimod alpha (5.3%) and placebo (6.3%).
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