{"doi":"10.1158/2767-9764.c.6762524","title":"Data from A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer","abstract":"<div>Purpose:<p>Neoadjuvant combination immune checkpoint blockade and intralesional oncolytic virotherapy have the potential to activate antitumor responses in patients with breast cancer.</p>Experimental Design:<p>Eligibility for this pilot phase I trial included patients with localized HER2-negative breast cancer who received systemic nivolumab and ipilimumab and intratumor talimogene laherparepvec (T-VEC; NCT04185311). The primary objective was to evaluate the safety and adverse event profile of immunotherapy combined with T-VEC in patients with localized, HER2-negative breast cancer.</p>Results:<p>Six patients were enrolled, 4 having relapses after prior neoadjuvant chemotherapy and 2 who were previously untreated. Toxicities included 1 patient having grade 3 hypotension and type 1 diabetes mellitus, 3 patients with hypothyroidism, and all patients having constitutional symptoms known to be associated with the administration of T-VEC. One patient had a pathologic complete response, 3 patients had pathologic partial responses, 1 showed no significant response, and 1 had disease progression. Biopsies demonstrated increased immune cell infiltration in samples from patients who responded to therapy.</p>Conclusions:<p>This triple immunotherapy regimen provided responses in patients with advanced or relapsed HER2-negative breast cancer, at the expense of long-term toxicities.</p>Significance:<p>Systemic immune checkpoint blockade with a programmed death receptor 1 and a CTL antigen-4 blocking antibody, combined with intralesional oncolytic virotherapy, is a chemotherapy-free combination aimed at inducing an antitumor immune response locally and systemic immunity.</p></div>","journal":null,"year":2023,"id":409902,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.8934,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":226341,"name":"Katie M. Campbell","orcid":"0000-0001-6491-4432","position":1,"is_corresponding":false},{"id":378458,"name":"Theodore S. Nowicki","orcid":"0000-0002-3815-6137","position":2,"is_corresponding":false},{"id":1067317,"name":"Nila Elumalai","orcid":null,"position":3,"is_corresponding":false},{"id":230456,"name":"Egmidio Medina","orcid":"0000-0002-3284-5329","position":4,"is_corresponding":false},{"id":370750,"name":"Ignacio Baselga-Carretero","orcid":"0000-0003-0229-4690","position":5,"is_corresponding":false},{"id":944974,"name":"Maggie L. DiNome","orcid":"0000-0002-1926-292X","position":6,"is_corresponding":false},{"id":602019,"name":"Helena R. Chang","orcid":"0000-0001-6939-4499","position":7,"is_corresponding":false},{"id":1066886,"name":"Denise K. Oseguera","orcid":"0009-0001-1793-1720","position":8,"is_corresponding":false},{"id":58599,"name":"Antoni Ribas","orcid":"0000-0003-3669-8458","position":9,"is_corresponding":false},{"id":58593,"name":"John A. Glaspy","orcid":"0000-0002-1800-9076","position":10,"is_corresponding":false},{"id":1066885,"name":"Vina P. Nguyen","orcid":"0000-0001-6851-3628","position":0,"is_corresponding":true}],"reference_count":27,"raw_metadata":null,"created_at":"2026-07-19T01:21:31.144858Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}