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Early efficacy analysis of the AE37 vaccine in patients with HER2 low-expressing and triple-negative breast cancer.
Session Type and Session Title:
General Poster Session B
Poster Discussion Session B
Poster Discussion Session B
J Clin Oncol 30, 2012 (suppl 27; abstr 109)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Peptide vaccines comprised of HLA class II epitopes, which elicit CD4+ T cell responses, play a critical role in potentiating immune responses. We are conducting a randomized phase II trial of AE37, a hybrid peptide created by the addition of the Ii-Key moiety (LRMK) to the HER2 helper epitope, AE36 (HER2 aa776-790). Here, we present efficacy data focusing on outcomes in patients with low HER2 (IHC 1+ or 2+) expression and triple negative breast cancer (TNBC). Methods: The trial is enrolling node positive or high risk node negative breast cancer patients with any degree of HER2 expression (IHC 1+, 2+ or 3+ or FISH > 1.2) rendered disease-free following standard of care therapy. Patients are randomized to receive either AE37+GM-CSF or GM-CSF alone in 6 monthly intradermal inoculations followed by booster inoculations administered every 6 months. Results: The trial has enrolled 254 patients; 105 in the vaccine group (VG) and 149 in the control group (CG). After a median follow-up of 22.3 months, the disease-free survival (DFS) rate in the VG is 90.3% vs 81.1% in the CG (p=.46), a 49% risk reduction. Evaluating patients with low HER2 expression (IHC 1+ or 2+), there are 53 VG patients and 77 CG patients. The groups are well-matched with respect to the percentage of patients with high grade tumors, tumors > 2cm, the rate of node positivity and ER/PR status (all p>.5). The DFS rate in the VG of low HER2 expressers is 89.8% vs 68.2% in the CG (p=.12), a 68% risk reduction. When limiting analyses to patients with TNBC (ER/PR negative, HER2 1+ or 2+), there are 13 VG patients and 23 CG patients. The groups are again well-matched with the exception of control patients having a larger percentage of tumors > 2 cm (70% vs 31%; p=.02). The DFS rate in the VG of TNBC patients is 83.3% vs 47.6% in the CG (p=.23), a 68% risk reduction. Conclusions: Early analyses suggest clinical benefit to vaccination with AE37, particularly in patients with low HER2-expressing tumors. Importantly, the benefit appears to persist in TNBC patients. Patients will continue to be followed per protocol for 5 years; however, these data suggest that a subsequent phase III trial should evaluate the vaccine in patients with low HER2-expressing disease to include TNBC.
Abstracts by Elizabeth Ann Mittendorf:
A nomogram to predict axillary response to neoadjuvant chemotherapy in clinically node positive breast patients.Meeting: 2015 ASCO Annual Meeting | Abstract No: 1034
Analytical validation of Bond Oracle HER2 IHC system for identifying low to intermediate HER2-expressing breast cancer in NeuVax PRESENT phase III clinical trial.Meeting: 2015 ASCO Annual Meeting | Abstract No: e11609Category: Breast Cancer—HER2/ER - HER2+
Associations of HER2-specific immunity with survival during treatment with trastuzumab and chemotherapy in breast cancer.Meeting: 2015 ASCO Annual Meeting | Abstract No: 587Category: Breast Cancer—HER2/ER - HER2+
Presentations by Elizabeth Ann Mittendorf:
Primary analysis of the prospective, randomized, phase II trial of GP2+GM-CSF vaccine versus GM-CSF alone administered in the adjuvant setting to high-risk breast cancer patients.Meeting: 2014 Breast Cancer Symposium Abstract No: 134Session: Oral Abstract Session B: Risk Assessment, Prevention, Early Detection, Screening, and Systemic Therapy (Oral Abstract Session)