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<identifier identifierType='DOI'>10.1093/annonc/mdz157.003</identifier>
<creators>
<creator>
<creatorName>Maglakelidze, M.</creatorName>
<affiliation>ARENSIA Exploratory Medicine LLC, Georgia</affiliation>
</creator>
<creator>
<creatorName>Yau, T.</creatorName>
<affiliation>Universitatea Chineză din Hong Kong, China</affiliation>
</creator>
<creator>
<creatorName>Bulat, I.B.</creatorName>
<affiliation>IMSP Institutul Oncologic, Moldova, Republica</affiliation>
</creator>
<creator>
<creatorName>Yen, C.</creatorName>
<affiliation>National Cheng Kung University Hospital Taiwan, China</affiliation>
</creator>
<creator>
<creatorName>Chao, Y.</creatorName>
<affiliation>Taipei Veterens General Hospital, Taipei City, China</affiliation>
</creator>
<creator>
<creatorName>Bai, L.</creatorName>
<affiliation>China Medical University Hospital, Taichung, China</affiliation>
</creator>
<creator>
<creatorName>Good, A.</creatorName>
<affiliation>China Medical University Hospital, Taichung, China</affiliation>
</creator>
<creator>
<creatorName>Ede, N.</creatorName>
<affiliation>China Medical University Hospital, Taichung, China</affiliation>
</creator>
<creator>
<creatorName>Chong, L.</creatorName>
<affiliation>China Medical University Hospital, Taichung, China</affiliation>
</creator>
<creator>
<creatorName>Tanasanvimon, S.</creatorName>
<affiliation>King Chulalongkorn Memorial Hospital, Bangkok, China</affiliation>
</creator>
</creators>
<titles>
<title xml:lang='en'>A phase 1b study of IMU-131 her2/neu peptide vaccine plus chemotherapy in patients with HER2/neu overexpressing metastatic or advanced adenocarcinoma of the stomach or gastroesophageal junction</title>
</titles>
<publisher>Instrumentul Bibliometric National</publisher>
<publicationYear>2019</publicationYear>
<relatedIdentifier relatedIdentifierType='ISSN' relationType='IsPartOf'>0923-7534</relatedIdentifier>
<dates>
<date dateType='Issued'>2019-07-01</date>
</dates>
<resourceType resourceTypeGeneral='Text'>Journal article</resourceType>
<descriptions>
<description xml:lang='en' descriptionType='Abstract'><p><strong>Introduction:</strong>&nbsp;Gastric cancer is the fifth most common cancer and the third leading cause of cancer deaths. HER2/neu is overexpressed in 15%-25% of patients with gastric cancer. Monoclonal antibodies against HER2/neu are effective but alternatives are needed due to the cost and lack of availability globally. IMU-131 is a B-cell peptide vaccine composed of a fusion of 3 epitopes from the extracellular domain of HER2/neu conjugated to CRM197 with the adjuvant Montanide. Polyclonal antibodies against IMU-131 peptides elicit antitumor activity in vitro and a phase I study demonstrated safety and immunogenicity in Her-2 +/ ++ breast cancer patients.</p><p><strong>Methods:</strong>&nbsp;IMU-131 was given to patients with HER2/neu overexpressing gastric or gastroesophageal junction (GEJ) adenocarcinoma in an international open-label Phase 1b dose-escalation trial performed in 14 Asian and Eastern European sites assessing safety, tolerability, and immunogenicity. Each patient received IMU-131 on Days 0, 14, and 35, accompanied by cisplatin and 5-fluorouracil or capecitabine every 21 days.</p><p><strong>Results:</strong>&nbsp;14 patients were enrolled with advanced stage IIIb or IV with 10 HER2 overexpressing tumors (7 x HER2 +++, 3 x HER2 ++ FISH positive) and 4 HER2 ++ expressing tumors. Mean age was 57 yo (range of 21 - 79) with ECOG scores of 0 or 1 in 7 patients each. There were 9 Asian and 5 Caucasian patients with 5 females and 9 males. Dose levels were 0.1, 0.3 and 0.5 mg with 3, 6, and 5 patients receiving those dose levels, respectively. Eleven patients received all 3 doses, 3 patients received only 2 doses due to disease progression, and 2 patients received a dose on day 182. Of the 14 patients dosed, 11 were evaluable for tumor progression at day 56 and later. Of those patients, the best response was 1 CR, 4 PR, 5 SD, and 1 PD. In the 0.1 mg dose group, the best response was 1 CR and 2 SD, with 2 PR, 2 SD, and 1 PD in the 0.3 mg group, and 2 PR and 1 SD in the 0.5 mg group. In patients with HER2 overexpression, there was 1 CR, 4 PR, 2 SD, and 1 PD, and in patients with HER2 ++ expression, there was 3 SD. There were no SAEs related to IMU-131 and 1 patient had a mild injection site reaction.</p><p><strong>Conclusion:</strong>&nbsp;IMU-131 is a promising B-Cell vaccine against HER2. Further work in a controlled phase 2 trial is ongoing.</p></description>
</descriptions>
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