Subgroup efficacy evaluation of the AE37 HER2 vaccine in breast cancer patients in the adjuvant setting.

Authors

null

Kaitlin M. Peace

San Antonio Military Medical Center, San Antonio, TX

Kaitlin M. Peace , Elizabeth Ann Mittendorf , Sonia A. Perez , Panagiotis Tzonis , Nikolaos Fragkiskos Pistamaltzian , Eleftheria A Anastasopoulou , Timothy J. Vreeland , Diane F Hale , Guy T Clifton , Jennifer Keating Litton , Eric von Hofe , Alexandros Ardavanis , Michael Papamichail , George Earl Peoples

Organizations

San Antonio Military Medical Center, San Antonio, TX, The University of Texas MD Anderson Cancer Center, Houston, TX, Cancer Immunology and Immunotherapy Center, Saint Savas Cancer Hospital, Athens, Greece, Saint Savvas Cancer Hospital, Maroussi Attica, Greece, Womack Army Medical Center, Ft. Bragg, NC, Antigen Express, Worcester, MA, Cancer Immunology and Immunotherapy Center, Athens, Greece, Cancer Vaccine Development Program, San Antonio, TX

Research Funding

Pharmaceutical/Biotech Company

Background: AE37 is a Ii-Key hybrid of the HER2 peptide AE36 (HER2776-790), which stimulates peptide-specific T cells. We have completed the active phase of a prospective, randomized, multi-center, phase II trial of the AE37 vaccine in the adjuvant setting. The primary analysis, performed after a median follow up (f/u) of 25 months (mo), did not show a significant difference in disease free survival (DFS) between vaccinated and control patients (pts). However, demonstrating the efficacy of cancer vaccines may require more time than other therapies, especially in malignancies with relatively late recurrences like breast cancer. Here, we present updated efficacy data after extended f/u in subgroups of pts stratified by clinicopathologic characteristics. Methods: Clinically disease-free, node positive or high-risk node negative pts with any level of HER2 expression were randomized to receive AE37 + GM-CSF (VG) or GM-CSF alone (CG) following standard of care therapy. Pts received 6 monthly intradermal inoculations during the primary vaccine series (PVS) followed by 4 boosters administered every 6 mo. Kaplan Meier and log rank analyses were performed from the time of the first inoculation in pts who completed at least the PVS, according to stage, node status, tumor size, HER2 expression and ER/PR status. Results: There were no clinicopathologic differences between groups in the 298 enrolled pts (VG = 153, CG = 145). The vaccine is safe and well tolerated. After a median f/u of 55 mo, there was a trend toward improved DFS in the VG among stage IIB/III pts (VG, n = 73, DFS 82% vs CG, n = 61, 67%, HR = 0.48, p = 0.06) and those with low HER2 expression (HER2 LE, VG, n = 68, 89% vs CG, n = 66, 51%, HR = 0.47, p = 0.1). Improved DFS in the VG was documented in patients with both stage IIB/III disease and HER2 LE (VG, n = 39, 90% vs CG, n = 38, 32%, HR 0.3, p = 0.02) and triple negative (TNBC) pts (VG, n = 21, 89% vs CG, n = 21, 0%, HR 0.26, p = 0.05). Conclusions: The AE37 vaccine is safe and well tolerated and has statistically significant efficacy in stage IIB/III pts with HER2 LE and in TNBC pts. This justifies further evaluation in a phase III study enrolling stage IIb/III pts not eligible for trastuzumab treatment and the very high risk TNBC group. Clinical trial information: NCT00524277

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Developmental Therapeutics—Immunotherapy

Track

Developmental Therapeutics and Translational Research,Immunotherapy

Sub Track

Vaccines

Clinical Trial Registration Number

NCT00524277

Citation

J Clin Oncol 35, 2017 (suppl; abstr 3088)

DOI

10.1200/JCO.2017.35.15_suppl.3088

Abstract #

3088

Poster Bd #

183

Abstract Disclosures

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