Initial safety analysis of a randomized phase II trial of nelipepimut-S + GM-CSF and trastuzumab compared to trastuzumab alone to prevent recurrence in breast cancer patients with HER2 low-expressing tumors

Clinical Immunology : the Official Journal of the Clinical Immunology Society
G Travis CliftonA Mittendorf Elizabeth

Abstract

The development of HER2-targeted therapy has decreased recurrence rates and improved survival, transforming the natural history of HER2-positive breast cancer. However only a minority of breast cancer patients benefit as these agents are not used in patients with tumors expressing low levels of HER2. Preclinical data suggests a synergistic action of HER2-targeted vaccination with trastuzumab. We report the initial safety interim analysis of a phase II trial that enrolled patients with HER2 low-expressing (IHC 1+/2+) breast cancer who were clinically disease-free after standard therapy. Patients were randomized to receive the HER2-peptide vaccine nelipepimut-S + GM-CSF with trastuzumab (vaccine arm) or trastuzumab + GM-CSF (control arm) and were followed for recurrence. A planned analysis that occurred after enrollment of 150 patients showed no significant differences in toxicity between the two arms, including cardiac toxicity. The clinical efficacy of this combination will be reported 6 months after the final patient was enrolled.

References

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Citations

Jan 10, 2020·Archivum Immunologiae Et Therapiae Experimentalis·Atefeh ArabJavad Behravan
Apr 25, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paolo TarantinoGiuseppe Curigliano
Jun 26, 2020·Frontiers in Cell and Developmental Biology·Daria S ChulpanovaValeriya V Solovyeva
Jan 25, 2021·Clinical Immunology : the Official Journal of the Clinical Immunology Society·R Connor ChickGeorge E Peoples
Mar 24, 2021·Cell Proliferation·Wensi LiuJianping Li
Sep 15, 2021·American Journal of Clinical Pathology·Huina ZhangDavid G Hicks

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