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• W4308396319 abstract "<h3>Background</h3> Individualized neoantigen cancer vaccines aim to benefit patients by generating strong, durable neoantigen-specific CD8 T cells. Previous data showed extended overall survival (OS) in patients with metastatic colorectal cancer (CRC) who achieved a molecular response (MR) versus those who did not after individualized neoantigen vaccination in combination with nivolumab and ipilimumab.¹ We report updated OS and analysis of clinicopathologic features of patients achieving a MR. <h3>Methods</h3> Patients with metastatic CRC, non-small cell lung cancer, or gastroesophageal adenocarcinoma who had received routine chemotherapy were treated in a Phase 1/2 first-in-human study (NCT03639714). The vaccine regimen consisted of sequential administrations of chimpanzee adenovirus and self-amplifying mRNA (samRNA) vectors encoding 20 patient-specific neoantigens in combination with nivolumab (IV 480 mg Q4W) and ipilimumab (SC 30 mg). <h3>Results</h3> Thirteen of 29 patients treated had CRC. Six of these 13 had stable disease (SD) and 7 had progressive disease (PD) per RECIST v1.1. Six patients achieved a MR defined as ≥ -30% reduction in ctDNA. Patients with a MR had prolonged overall survival (OS) compared to patients without a MR (see Table 1). MR was not associated with primary tumor location, presence of liver metastases, or <i>RAS</i> mutations and patients with a MR were not enriched for higher tumor mutation burden (TMB), PD-L1, or T cell inflamed gene expression profiles (GEP), and had similar baseline ctDNA values based on variant allele frequency (VAF) (p-value=0.18) (table 1). <h3>Conclusions</h3> Patients who achieved MR had extended OS compared with those patients without MR. Patients with a MR were not enriched based on primary or metastatic tumor site or known correlates of response to checkpoint inhibitors. The lower baseline VAF observed in patients with a MR may be reflective of VAF in early metastatic disease. A subsequent, ongoing randomized study is evaluating individualized neoantigen vaccine in the 1L maintenance setting (NCT05141721). <h3>Acknowledgements</h3> We thank patients and their families for participating in this clinical study and Bristol-Myers Squibb for supply of nivolumab and ipilimumab. <h3>Trial Registration</h3> NCT03639714 <h3>Reference</h3> Catenacci <i>et al</i>. Clinical outcomes and immune responses in a phase I/II study of personalized, neoantigen-directed immunotherapy in patients with advanced MSS-CRC, GEA and NSCLC. European Society of Medical Oncology Annual Meeting 2021. https://doi.org/10.1016/j.annonc.2021.08.1345 <h3>Ethics Approval</h3> This study was reviewed and approved by institutional review boards at participating clinical sites and all patients gave informed consent before taking part in this clinical study." @default.
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• W4308396319 date "2022-11-01" @default.
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• W4308396319 title "660 Clinicopathologic characteristics of patients with metastatic colorectal cancer with molecular responses following treatment with an individualized neoantigen vaccine regimen" @default.
• W4308396319 doi "https://doi.org/10.1136/jitc-2022-sitc2022.0660" @default.
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