– Immune Stimulation Augmented by +1,300% at 6-months Post-NPS Treatment –
– Statistically Significant Difference of Duration of Immune Response of NPS vs. Control: p=0.000094 -
– Data to be Presented Today at the San Antonio Breast Cancer Symposium -
Preliminary data previously reported showed that treatment with even a single dose of NPS was capable of newly inducing NPS-specific cytotoxic T-lymphocytes (CTLs) in peripheral blood in DCIS patients. The updated data, based on a 6-month follow-up, demonstrate that CD8+ T-cell responses persist long-term post-NPS treatment, with treated patients retaining and modestly enhancing their antigen-specific immune response. When compared to baseline (BL, prior to investigational agent administration), the relative frequency of NPS-specific CD8 CTLs as a percentage (NPS-CLT%) in peripheral blood at the 1-month and 6-month post-operative time-points increased in the NPS+GM-CSF group (n=9) by 11- and 14-fold: 0.01+0.02% [BL] vs. 0.11+0.12% [1-mo] and 0.14+0.12% [6-mo], respectively, while in the GM-CSF alone group (n=4) the NPS-CLT% in peripheral blood increased by only 2.25- and 3.75-fold: 0.04+0.07% [BL] vs. 0.09+0.15% [1-mo] and 0.15+0.03% [6-mo], respectively.
For the NPS+GM-CSF group, the differences in absolute NPS-CTL% mean values between baseline and 1- or 6-months post-vaccination were statistically significant, with p-values of 0.039 and 0.0125, respectively. The relative change in NPS-CTL% mean values at 6 months post-vaccination was +1,300+450% for the NPS+GM-CSF group vs. 250+150% in the GM-CSF alone group, which was highly statistically significant in favor of the NPS+GM-CSF group: p=0.000094.
“These data confirm that NPS confers long-term immune response in DCIS patients, with continued, and in fact slightly augmented, antigen-specific T-cell response for up to 6 months post-vaccination in a randomized setting,” said
The VADIS study enrolled 13 patients, with nine patients receiving NPS plus GM-CSF and four patients receiving GM-CSF only. The NPS-CLT% was measured in the peripheral blood by a sensitive and specific assay using dextramer staining followed by flow cytometry, both at baseline (before vaccination or GM-CSF), as well as at 30 (+7) and 180 (+7) days after surgery. Further data from additional analyses of select histologic and molecular biomarkers will be presented in a future scientific meeting.
There were no drug-related unexpected serious adverse reactions in the study. The overall adverse event profile of the NPS+GM-CSF combination was similar to the adverse event profile seen with GM-CSF alone. Almost all patients in both arms experienced at least Grade 1 toxicities, and the incidence of Grade 2 toxicities was 6.7% in the GPS+GM-CSF arm and 10.7% in the GM-CSF only arm.
“These results further support the case for continued development of NPS in HER2-expressing breast cancer, as well as potentially other HER2-bearing cancers,” said
About the VADIS spotlight poster presentation (PD11-09)
The VADIS data will be presented today,
Title: Vadis trial: phase II trial of Nelipepimut-S peptide vaccine in women with DCIS of the breast.
Authors: O’Shea AE, Clifton GT, Qiao N,
Presenter: Anne E. O’Shea, MD
Poster Discussion No.: PD11-09
Session Date – Time:
Website: www.sabcs.org
About the Phase 2 VADIS Trial
This Phase 2 randomized trial is sponsored and operationalized by the
About DCIS
DCIS is defined by the NCI as a noninvasive condition in which abnormal cells are found in the lining of a breast duct and have not spread outside the duct to other tissues in the breast. DCIS is the most common type of breast neoplasm with malignant potential. In some cases, DCIS may become invasive cancer and spread to other tissues and, currently, it is not possible to know which lesions could become invasive. Current treatment options for DCIS include breast-conserving surgery and radiation therapy with or without tamoxifen, breast-conserving surgery without radiation therapy, or total mastectomy with or without tamoxifen. Tamoxifen is given in cases with hormone receptor positivity only. No targeted or immune therapies have shown any definitive clinical activity in DCIS to date. The current standard treatment aims at forestalling the progression of DCIS to invasive cancer. In approximately 15-25% of cases progression does occur. DCIS is diagnosed in more than 60,000 women each year in
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Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the clinical development of NPS for breast cancer, including DCIS, and the potential for NPS as a drug development candidate. These forward-looking statements are based on current plans, objectives, estimates, expectations and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with immune-oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting
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