&lt;p&gt;Evaluating Nelipepimut-S in the Treatment of Breast Cancer: A Short Report on the Emerging Data&lt;/p&gt;

Dillon, Patrick M.; Brenin, Christiana; Slingluff, Craig L.

doi:10.2147/bctt.s224758

Cited by 12 publications

(12 citation statements)

References 23 publications

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“…26 Her2 369-377 vaccination in breast cancer has also been extensively evaluated: despite initially promising findings, Phase III multicenter trials did not demonstrate reductions in disease-free survival. [27][28][29][30] Whether CEA and/or Her2 vaccination may offer clinical benefits in CRC remains to be seen; furthermore, to our knowledge the immunogenicity of HLA-type A3 peptides has not been previously assessed in CRC patients. As reviewed by Lynch and Murphy, 17 a variety of vaccine approaches for CRC have been studied in clinical trials, including dendritic cell vaccines, autologous-tumor cell vaccines and viral vaccines.…”

Section: Discussionmentioning

confidence: 99%

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer

Lynch

Squeo

Kane

et al. 2021

Intl Journal of Cancer

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Checkpoint-blockade therapy (CBT) is approved for select colorectal cancer (CRC) patents, but additional immunotherapeutic options are needed. We hypothesized that vaccination with carcinoembryonic antigen (CEA) and Her2/neu (Her2) peptides would be immunogenic and well tolerated by participants with advanced CRC. A pilot clinical trial (NCT00091286) was conducted in HLA-A2 + or -A3 + Stage IIIC-IV CRC patients. Participants were vaccinated weekly with CEA and Her2 peptides plus tetanus peptide and GM-CSF emulsified in Montanide ISA-51 adjuvant for 3 weeks.Adverse events (AEs) were recorded per NIH Common Terminology Criteria for Adverse Events version 3. Immunogenicity was evaluated by interferon-gamma ELISpot assay of in vitro sensitized peripheral blood mononuclear cells and lymphocytes from the sentinel immunized node. Eleven participants were enrolled and treated; one was retrospectively found to be ineligible due to HLA type. All 11 participants were included in AEs and survival analyses, and the 10 eligible participants were evaluated for immunogenicity. All participants reported AEs: 82% were Grade 1-2, most commonly fatigue or injection site reactions. Two participants (18%) experienced treatment-related dose-limiting Grade 3 AEs; both were self-limiting. Immune responses to Her2 or CEA peptides were detected in 70% of participants. Median overall survival (OS) was 16 months; among those enrolled with no evidence of disease (n = 3), median OS was not reached after 10 years of follow-up. These data demonstrate that vaccination with CEA or Her2 peptides is well tolerated and immunogenic. Further study is warranted to assess potential clinical benefits of vaccination in advanced CRC either alone or in combination with CBT.

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Section: Discussionmentioning

confidence: 99%

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer

Lynch

Squeo

Kane

et al. 2021

Intl Journal of Cancer

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“…90 Based on the results from this phase III trial, combination studies were designed. 91 In an ongoing phase II trial, patients with ductal carcinoma in situ of the breast (NCT02636582; Table 2) were treated either with nelipepimut-S or with sargramostim (the recombinant GM-CSF). The aim of this study, with pending results, is to evaluate the level of circulating immune response at 6 months after vaccination, as well as toxicity and safety.…”

Section: E75 Gp2 Ae37 Multi-peptidementioning

confidence: 99%

Vaccination against Her-2/neu, with focus on peptide-based vaccines

et al. 2022

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Immunotherapy has been a milestone in combatting cancer, by complementing or even replacing classic treatments like surgery, chemotherapy, radiation, and anti-hormonal therapy. In 15%-30% of breast cancers, overexpression of the human epidermal growth factor receptor 2 (Her-2/neu) is associated with more aggressive tumor development.Passive immunization/immunotherapy with the recombinantly produced Her-2/neu-targeting monoclonal antibodies (mAbs) pertuzumab and trastuzumab has been shown to effectively treat breast cancer and lead to a significantly better prognosis. However, allergic and hypersensitivity reactions, cardiotoxicity, development of resistance, lack of immunological memory which results in continuous application over a long period, and cost-intensiveness are among the drawbacks associated with this treatment. Furthermore, intrinsic or acquired resistance is associated with the application of therapeutic mAbs, leading to the disease recurrence. Conversely, these drawbacks could be potentially overcome by vaccination, i.e. an active immunization/immunotherapy approach by activating the patient's own immune system to target cancer, along with inducing immunological memory. This review aims to summarize the main approaches investigated and undertaken for the production of Her-2/neu vaccine candidates, with the main focus on peptide-based vaccines and their evaluation in clinical settings.

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“…NeuVax is the only HER2-targeted vaccine that has completed a phase III clinical trial (the PRESENT trial); however, the results indicate that the application of NeuVax might result in a high risk of recurrence. 79 …”

Section: Anti-her2 Combined Therapiesmentioning

confidence: 99%

Therapeutic Landscape of Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer

et al. 2022

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Human epidermal growth factor receptor 2–positive breast cancer (HER2+BC) is a common malignancy that is prone to recurrence and metastasis in the early stages, resulting in a poor prognosis for patients. Many studies have suggested that targeted therapy promotes clinical outcomes in HER2+BC. With the introduction of trastuzumab in 1998, the prognosis of patients with early HER2+BC has improved significantly. However, owing to obstinate drug resistance and adverse events, the addition of new agents in standardized treatment has become a research hotspot. These promising agents include antibodies, antibody-drug conjugates, tyrosine kinase inhibitors, and anti-HER2 combined therapies. This article provides a brief description of the biology of BC and the expression of HER2, with the aim to provide an overview of the therapeutic landscape of HER2+BC by reviewing research results and introducing the latest evidence to provide a reference for clinical treatment.

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<p>Evaluating Nelipepimut-S in the Treatment of Breast Cancer: A Short Report on the Emerging Data</p>

Cited by 12 publications

References 23 publications

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer

A pilot trial of vaccination with Carcinoembryonic antigen and Her2/neu peptides in advanced colorectal cancer

Vaccination against Her-2/neu, with focus on peptide-based vaccines

Therapeutic Landscape of Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer

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