dc.contributor.author | Somaiah, N | |
dc.contributor.author | Chawla, SP | |
dc.contributor.author | Block, MS | |
dc.contributor.author | Morris, JC | |
dc.contributor.author | Do, K | |
dc.contributor.author | Kim, JW | |
dc.contributor.author | Druta, M | |
dc.contributor.author | Sankhala, KK | |
dc.contributor.author | Hwu, P | |
dc.contributor.author | Jones, RL | |
dc.contributor.author | Gnjatic, S | |
dc.contributor.author | Kim-Schulze, S | |
dc.contributor.author | Tuballes, K | |
dc.contributor.author | Yishak, M | |
dc.contributor.author | Lu, H | |
dc.contributor.author | Yakovich, A | |
dc.contributor.author | Ter Meulen, J | |
dc.contributor.author | Chen, M | |
dc.contributor.author | Kenney, RT | |
dc.contributor.author | Bohac, C | |
dc.contributor.author | Pollack, SM | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-09-02T13:56:24Z | |
dc.date.available | 2022-09-02T13:56:24Z | |
dc.date.issued | 2020-11-19 | |
dc.identifier | ARTN 1847846 | |
dc.identifier | 1847846 | |
dc.identifier.citation | OncoImmunology, 2020, 9 (1), pp. 1847846 - | en_US |
dc.identifier.issn | 2162-4011 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5395 | |
dc.identifier.eissn | 2162-402X | |
dc.identifier.eissn | 2162-402X | |
dc.identifier.doi | 10.1080/2162402X.2020.1847846 | |
dc.description.abstract | Preclinical data suggest that a "prime-boost" vaccine regimen using a target-expressing lentiviral vector for priming, followed by a recombinant protein boost, may be effective against cancer; however, this strategy has not been evaluated in a clinical setting. CMB305 is a prime-boost vaccine designed to induce a broad anti-NY-ESO-1 immune response. It is composed of LV305, which is an NY-ESO-1 expressing lentiviral vector, and G305, a recombinant adjuvanted NY-ESO-1 protein. This multicenter phase 1b, first-in-human trial evaluated CMB305 in patients with NY-ESO-1 expressing solid tumors. Safety was examined in a 3 + 3 dose-escalation design, followed by an expansion with CMB305 alone or in a combination with either oral metronomic cyclophosphamide or intratumoral injections of a toll-like receptor agonist (glucopyranosyl lipid A). Of the 79 patients who enrolled, 81.0% had sarcomas, 86.1% had metastatic disease, and 57.0% had progressive disease at study entry. The most common adverse events were fatigue (34.2%), nausea (26.6%), and injection-site pain (24.1%). In patients with soft tissue sarcomas, a disease control rate of 61.9% and an overall survival of 26.2 months (95% CI, 22.1-NA) were observed. CMB305 induced anti-NY-ESO-1 antibody and T-cell responses in 62.9% and 47.4% of patients, respectively. This is the first trial to test a prime-boost vaccine regimen in patients with advanced cancer. This approach is feasible, can be delivered safely, and with evidence of immune response as well as suggestion of clinical benefit. | |
dc.format | Electronic | |
dc.format.extent | 1847846 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | TAYLOR & FRANCIS INC | en_US |
dc.relation.ispartof | OncoImmunology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.subject | G305 | |
dc.subject | LV305 | |
dc.subject | NY-ESO-1 | |
dc.subject | immunotherapy | |
dc.subject | lentivirus | |
dc.subject | myxoid liposarcoma | |
dc.subject | prime-boost | |
dc.subject | synovial sarcoma | |
dc.subject | vaccine | |
dc.subject | Adjuvants, Immunologic | |
dc.subject | Antigens, Neoplasm | |
dc.subject | Cancer Vaccines | |
dc.subject | Humans | |
dc.subject | Membrane Proteins | |
dc.subject | Sarcoma | |
dc.title | A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine Regimen, in Patients with Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2020-11-03 | |
dc.date.updated | 2022-09-02T13:55:14Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1080/2162402X.2020.1847846 | en_US |
rioxxterms.licenseref.startdate | 2020-11-19 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/33312760 | |
pubs.issue | 1 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials (R Jones)/Sarcoma Clinical Trials (R Jones) (hon.) | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1080/2162402x.2020.1847846 | |
pubs.volume | 9 | |
dc.contributor.icrauthor | Jones, Robin | |
icr.provenance | Deposited by Mr Arek Surman on 2022-09-02. Deposit type is initial. No. of files: 1. Files: A Phase 1b Study Evaluating the Safety, Tolerability, and Immunogenicity of CMB305, a Lentiviral-Based Prime-Boost Vaccine R.pdf | |