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 SM ISO690:2012MAGLAKELIDZE, Marina, YAU, Thomas, BULAT, Iurie, YEN, Chiajui, CHAO, Y., BAI, L., GOOD, A., EDE, N., CHONG, L., TANASANVIMON, Suebpong. 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. In: Annals of oncology, 2019, nr. 10(30), p. 0. ISSN 0923-7534. DOI: https://doi.org/10.1093/annonc/mdz157.003 |
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  Annals of oncology |
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| Numărul 10(30) / 2019 / ISSN 0923-7534 /ISSNe 1569-8041 | |
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| DOI:https://doi.org/10.1093/annonc/mdz157.003 | |
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Introduction: 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.Methods: 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.Results: 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.Conclusion: IMU-131 is a promising B-Cell vaccine against HER2. Further work in a controlled phase 2 trial is ongoing. |
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<?xml version='1.0' encoding='utf-8'?> <oai_dc:dc xmlns:dc='http://purl.org/dc/elements/1.1/' xmlns:oai_dc='http://www.openarchives.org/OAI/2.0/oai_dc/' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance' xsi:schemaLocation='http://www.openarchives.org/OAI/2.0/oai_dc/ http://www.openarchives.org/OAI/2.0/oai_dc.xsd'> <dc:creator>Maglakelidze, M.</dc:creator> <dc:creator>Yau, T.</dc:creator> <dc:creator>Bulat, I.B.</dc:creator> <dc:creator>Yen, C.</dc:creator> <dc:creator>Chao, Y.</dc:creator> <dc:creator>Bai, L.</dc:creator> <dc:creator>Good, A.</dc:creator> <dc:creator>Ede, N.</dc:creator> <dc:creator>Chong, L.</dc:creator> <dc:creator>Tanasanvimon, S.</dc:creator> <dc:date>2019-07-01</dc:date> <dc:description xml:lang='en'><p><strong>Introduction:</strong> 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> 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> 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> IMU-131 is a promising B-Cell vaccine against HER2. Further work in a controlled phase 2 trial is ongoing.</p></dc:description> <dc:identifier>10.1093/annonc/mdz157.003</dc:identifier> <dc:source>Annals of oncology 30 (10) 0-0</dc:source> <dc:title>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</dc:title> <dc:type>info:eu-repo/semantics/article</dc:type> </oai_dc:dc>
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