Phase II clinical trial using anti-CD3 × anti-HER2 bispecific antibody armed activated T cells (HER2 BATs) consolidation therapy for HER2 negative (0-2+) metastatic breast cancer.

Journal for Immunotherapy of Cancer
Lawrence G LumArchana Thakur

Abstract

Metastatic human epidermal growth receptor II (HER2) negative breast cancer remains incurable. Our phase I study showed that anti-CD3 × anti-HER2 bispecific antibody armed activated T cells (HER2 BATs) may be effective against HER2-tumors. This phase II trial evaluates the efficacy and immune responses of HER2 BATs given to patients with metastatic HER2-estrogen and/or progesterone receptor positive (HR+) and triple negative breast cancer (TNBC) as immune consolidation after chemotherapy. The primary objective of this study was to increase the traditional median time to progression after failure of first-line therapy of 2-4 months with the secondary endpoints of increasing overall survival (OS) and immune responses. HER2- metastatic breast cancer (MBC) patients received 3 weekly infusions of HER2 BATs and a boost after 12 weeks. This phase II study included 24 HER2-HR+ and 8 TNBC patients who received a mean of 3.75 and 2.4 lines of prior chemotherapy, respectively. Eight of 32 evaluable patients were stable at 4 months after the first infusion. There were no dose limiting toxicities. Tumor markers decreased in 13 of 23 (56.5%) patients who had tumor markers. The median OS was 13.1 (95% CI 8.6 to 17.4), 15.2 (95% CI 8.6 to 19.8...Continue Reading

References

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Jan 24, 2006·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Ryan C GrabertLawrence G Lum
Mar 24, 2007·Breast Cancer Research and Treatment·Armelle DufresneAimery De Gramont
Oct 29, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Joyce O'ShaughnessyEric P Winer
Feb 18, 2015·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Lawrence G LumRitesh Rathore
Apr 8, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Steven J IsakoffLeif W Ellisen
Dec 14, 2018·Oncoimmunology·Archana ThakurLawrence G Lum

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