{"doi":"10.1200/jco.22.00996","title":"Phase IIa Study of SurVaxM Plus Adjuvant Temozolomide for Newly Diagnosed Glioblastoma","abstract":"PURPOSE: Despite intensive treatment with surgery, radiation therapy, temozolomide (TMZ) chemotherapy, and tumor-treating fields, mortality of newly diagnosed glioblastoma (nGBM) remains very high. SurVaxM is a peptide vaccine conjugate that has been shown to activate the immune system against its target molecule survivin, which is highly expressed by glioblastoma cells. We conducted a phase IIa, open-label, multicenter trial evaluating the safety, immunologic effects, and survival of patients with nGBM receiving SurVaxM plus adjuvant TMZ following surgery and chemoradiation (ClinicalTrials.gov identifier: NCT02455557). METHODS: Sixty-four patients with resected nGBM were enrolled including 38 men and 26 women, in the age range of 20-82 years. Following craniotomy and fractionated radiation therapy with concurrent TMZ, patients received four doses of SurVaxM (500 μg once every 2 weeks) in Montanide ISA-51 plus sargramostim (granulocyte macrophage colony-stimulating factor) subcutaneously. Patients subsequently received adjuvant TMZ and maintenance SurVaxM concurrently until progression. Progression-free survival (PFS) and overall survival (OS) were reported. Immunologic responses to SurVaxM were assessed. RESULTS: SurVaxM plus TMZ was well tolerated with no serious adverse events attributable to SurVaxM. Of the 63 patients who were evaluable for outcome, 60 (95.2%) remained progression-free 6 months after diagnosis (prespecified primary end point). Median PFS was 11.4 months and median OS was 25.9 months measured from first dose of SurVaxM. SurVaxM produced survivin-specific CD8+ T cells and antibody/immunoglobulin G titers. Apparent clinical benefit of SurVaxM was observed in both methylated and unmethylated patients. CONCLUSION: SurVaxM appeared to be safe and well tolerated. The combination represents a promising therapy for nGBM. For patients with nGBM treated in this manner, PFS may be an acceptable surrogate for OS. A large randomized clinical trial of SurVaxM for nGBM is in progress.","journal":"Journal of Clinical Oncology","year":2022,"id":232874,"datarank":2.320140618308719,"base_score":5.075173815233827,"endowment":5.075173815233827,"self_citation_contribution":0.7612760722850741,"citation_network_contribution":1.558864546023645,"self_endowment_contribution":0.7612760722850741,"citer_contribution":1.558864546023645,"corpus_percentile":null,"corpus_rank":null,"citation_count":159,"citer_count":100,"citers_with_citation_signal":100,"citers_with_endowment":100,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9493,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02455557"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":25295,"name":"David A. Reardon","orcid":"0000-0001-6674-0157","position":1,"is_corresponding":false},{"id":707092,"name":"Ajay Abad","orcid":null,"position":2,"is_corresponding":false},{"id":11408,"name":"William T. Curry","orcid":"0000-0002-8036-1847","position":3,"is_corresponding":false},{"id":844284,"name":"Eric T. Wong","orcid":"0000-0001-7112-6207","position":4,"is_corresponding":false},{"id":767824,"name":"Sheila Figel","orcid":"0000-0001-8105-4278","position":5,"is_corresponding":false},{"id":706512,"name":"Laszlo Mechtler","orcid":"0000-0002-6105-9159","position":6,"is_corresponding":false},{"id":255947,"name":"David M. Peereboom","orcid":"0000-0001-7798-5176","position":7,"is_corresponding":false},{"id":328926,"name":"Alan D. Hutson","orcid":"0000-0002-7353-5650","position":8,"is_corresponding":false},{"id":844285,"name":"Henry Withers","orcid":"0000-0002-9746-9352","position":9,"is_corresponding":false},{"id":247366,"name":"Song Liu","orcid":"0000-0001-6351-2941","position":10,"is_corresponding":false},{"id":534638,"name":"Ahmed Belal","orcid":null,"position":11,"is_corresponding":false},{"id":406216,"name":"Jingxin Qiu","orcid":"0000-0003-4595-4134","position":12,"is_corresponding":false},{"id":845298,"name":"Kathleen Mogensen","orcid":null,"position":13,"is_corresponding":false},{"id":768473,"name":"Sanam Dharma","orcid":null,"position":14,"is_corresponding":false},{"id":261747,"name":"Andrew Dhawan","orcid":"0000-0002-5027-1277","position":15,"is_corresponding":false},{"id":768472,"name":"Meaghan Birkemeier","orcid":null,"position":16,"is_corresponding":false},{"id":845299,"name":"Danielle Casucci","orcid":null,"position":17,"is_corresponding":false},{"id":767825,"name":"Michael J. Ciesielski","orcid":"0000-0002-3373-9421","position":18,"is_corresponding":false},{"id":706515,"name":"Robert A. Fenstermaker","orcid":"0000-0003-0309-8130","position":19,"is_corresponding":false},{"id":225594,"name":"Manmeet S. Ahluwalia","orcid":"0000-0003-3794-9511","position":0,"is_corresponding":true}],"reference_count":33,"raw_metadata":null,"created_at":"2026-07-19T00:21:18.683916Z","pmid":"36521103","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":[]}