Abstract 150P
Background
HER2/neu is overexpressed in 15% - 25% of gastric cancers. IMU-131 is a B-cell peptide vaccine composed of 3 epitopes of the extracellular domain of HER2/neu. 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 positive gastric cancer in an open-label phase 1b dose escalation trial with 14 Asian and Eastern European sites. Each patient received IMU-131 on Days 0, 14, and 35, with cisplatin and 5-fluorouracil or capecitabine every 21 days. Patients remained on study until disease progression. Ongoing patients received boosters at D98 then every 84 days.
Results
14 patients were enrolled with 10 HER2 overexpressing (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 10, 30 and 50 µg with 3, 6, and 5 patients respectively. 11 patients received all 3 doses and 3 patients received only 2 doses due to disease progression. P467 and HER2 antibodies were generated at all dose levels with patients dosed at 50µg responding to the vaccine with equally high antibody levels. There were no DLTs or SAEs related to IMU-131. 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, 5 PR, 4 SD and 1 PD. Two patients, both dosed at 50µg IMU-131, remain on study after D266, with one patient’s tumor reduced by approximately 80% from 177mm at baseline to 37mm at D266.
Conclusions
Safety data indicate that IMU-131 is well tolerated with no significant local or systemic reactions. There were no dose-limiting toxicities observed, no significant injection site reactions and no IMU-131 related SAEs. The 50µg dose produced the most consistent P467 and HER-2 specific antibodies compared to 10 and 30µg doses with preliminary response data demonstrating 50µg of IMU-131 is associated with tumor size reduction. The 50µg dose of IMU-131 is being used in the phase 2 study.
Clinical trial identification
Identifier: NCT02795988.
Editorial acknowledgement
Legal entity responsible for the study
Imugene Ltd.
Funding
Imugene Ltd.
Disclosure
N. Ede: Full / Part-time employment: Imugene. L. Chong: Full / Part-time employment, Officer / Board of Directors: Imugene. A. Good: Full / Part-time employment: Imugene. All other authors have declared no conflicts of interest.
Resources from the same session
504P - A single center report for safety and efficacy of CT-707 in Chinese patients with advanced, anaplastic lymphoma kinase-rearranged non-small cell lung cancer or other tumours
Presenter: Peng Song
Session: Poster display session
Resources:
Abstract
519P - Initial results of lung cancer genomic screening project for individualized medicine in Asia: LC-SCRUM-Asia
Presenter: Chih-Hsi Kuo
Session: Poster display session
Resources:
Abstract
521P - A randomized, phase II study comparing irinotecan versus amrubicin as maintenance therapy after first-line induction therapy for extensive disease small cell lung cancer (HOT1401/NJLCG1401)
Presenter: Keisuke Baba
Session: Poster display session
Resources:
Abstract
526P - A phase II study of apatinib in patients with recurrent/metastatic esophageal squamous cell carcinoma (ESCC)
Presenter: Li Chu
Session: Poster display session
Resources:
Abstract
499P - Prevalence of uncommon epidermal growth factor receptor (EGFR) alterations detected by circulating tumour DNA (ctDNA) in non-small cell lung cancer (NSCLC) patients in Hong Kong
Presenter: Oscar Siu Hong Chan
Session: Poster display session
Resources:
Abstract
489P - Overall survival in patients with EGFRm+ NSCLC receiving sequential afatinib and osimertinib: Updated analysis of the GioTag study
Presenter: Maximilian J. Hochmair
Session: Poster display session
Resources:
Abstract
509P - Second-line treatment after first-line vinorelbine in advanced platinum unfit NSCLC patients: An exploratory analysis of randomized Tempo-Lung trial
Presenter: Andrea Camerini
Session: Poster display session
Resources:
Abstract
500P - Clinico-molecular characteristics of Chinese primary non-small cell lung cancer patients with compound EGFR mutations
Presenter: Jianchun Duan
Session: Poster display session
Resources:
Abstract
527P - A multicenter study of NRG1 fusions in Chinese non-small cell lung cancer patients and response to afatinib using next generation sequencing
Presenter: Xingliang Li
Session: Poster display session
Resources:
Abstract
481P - Updated survival outcomes of the phase II study of low starting dose of afatinib as first-line treatment in patients with EGFR mutation-positive non-small cell lung cancer (KTORG1402)
Presenter: Toshihide Yokoyama
Session: Poster display session
Resources:
Abstract