Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE)
DC Field | Value | Language |
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dc.contributor.author | Moehler, M. | - |
dc.contributor.author | Heo, J. | - |
dc.contributor.author | Lee, H. C. | - |
dc.contributor.author | Tak, W. Y. | - |
dc.contributor.author | Chao, Y. | - |
dc.contributor.author | Paik, S. W. | - |
dc.contributor.author | Yim, H. J. | - |
dc.contributor.author | Byun, K. S. | - |
dc.contributor.author | Baron, A. | - |
dc.contributor.author | Ungerechts, G. | - |
dc.contributor.author | Jonker, D. | - |
dc.contributor.author | Ruo, L. | - |
dc.contributor.author | Cho, M. | - |
dc.contributor.author | Kaubisch, A. | - |
dc.contributor.author | Wege, H. | - |
dc.contributor.author | Merle, P. | - |
dc.contributor.author | Ebert, O. | - |
dc.contributor.author | Habersetzer, F. | - |
dc.contributor.author | Blanc, J. F. | - |
dc.contributor.author | Rosmorduc, Olivier | - |
dc.contributor.author | Lencioni, R. | - |
dc.contributor.author | Patt, R. | - |
dc.contributor.author | Leen, A. M. | - |
dc.contributor.author | Foerster, F. | - |
dc.contributor.author | Homerin, M. | - |
dc.contributor.author | Stojkowitz, N. | - |
dc.contributor.author | Lusky, M. | - |
dc.contributor.author | Limacher, J. M. | - |
dc.contributor.author | Hennequi, M. | - |
dc.contributor.author | Gaspar, N. | - |
dc.contributor.author | McFadden, B. | - |
dc.contributor.author | De Silva, N. | - |
dc.contributor.author | Shen, D. | - |
dc.contributor.author | Pelusio, A. | - |
dc.contributor.author | Kirn, D. H. | - |
dc.contributor.author | Breitbach, C. J. | - |
dc.contributor.author | Burke, J. M. | - |
dc.date.accessioned | 2021-09-01T09:40:06Z | - |
dc.date.available | 2021-09-01T09:40:06Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2019-08-03 | - |
dc.identifier.issn | 2162-4011 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/63561 | - |
dc.description.abstract | Pexastimogene devacirepvec (Pexa-Vec) is a vaccinia virus-based oncolytic immunotherapy designed to preferentially replicate in and destroy tumor cells while stimulating anti-tumor immunity by expressing GM-CSF. An earlier randomized Phase IIa trial in predominantly sorafenib-naive hepatocellular carcinoma (HCC) demonstrated an overall survival (OS) benefit. This randomized, open-label Phase IIb trial investigated whether Pexa-Vec plus Best Supportive Care (BSC) improved OS over BSC alone in HCC patients who failed sorafenib therapy (TRAVERSE). 129 patients were randomly assigned 2:1 to Pexa-Vec plus BSC vs. BSC alone. Pexa-Vec was given as a single intravenous (IV) infusion followed by up to 5 IT injections. The primary endpoint was OS. Secondary endpoints included overall response rate (RR), time to progression (TTP) and safety. A high drop-out rate in the control arm (63%) confounded assessment of response-based endpoints. Median OS (ITT) for Pexa-Vec plus BSC vs. BSC alone was 4.2 and 4.4 months, respectively (HR, 1.19, 95% CI: 0.78-1.80; p = .428). There was no difference between the two treatment arms in RR or TTP. Pexa-Vec was generally well-tolerated. The most frequent Grade 3 included pyrexia (8%) and hypotension (8%). Induction of immune responses to vaccinia antigens and HCC associated antigens were observed. Despite a tolerable safety profile and induction of T cell responses, Pexa-Vec did not improve OS as second-line therapy after sorafenib failure. The true potential of oncolytic viruses may lie in the treatment of patients with earlier disease stages which should be addressed in future studies. ClinicalTrials.gov: NCT01387555 | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | TAYLOR & FRANCIS INC | - |
dc.subject | MODIFIED RECIST MRECIST | - |
dc.subject | 2ND-LINE TREATMENT | - |
dc.subject | CLINICAL-TRIAL | - |
dc.subject | DOUBLE-BLIND | - |
dc.subject | CANCER | - |
dc.subject | JX-594 | - |
dc.subject | THERAPY | - |
dc.subject | PLACEBO | - |
dc.subject | HEPATITIS | - |
dc.subject | TARGETS | - |
dc.title | Vaccinia-based oncolytic immunotherapy Pexastimogene Devacirepvec in patients with advanced hepatocellular carcinoma after sorafenib failure: a randomized multicenter Phase IIb trial (TRAVERSE) | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Byun, K. S. | - |
dc.identifier.doi | 10.1080/2162402X.2019.1615817 | - |
dc.identifier.scopusid | 2-s2.0-85067007305 | - |
dc.identifier.wosid | 000471565100001 | - |
dc.identifier.bibliographicCitation | ONCOIMMUNOLOGY, v.8, no.8 | - |
dc.relation.isPartOf | ONCOIMMUNOLOGY | - |
dc.citation.title | ONCOIMMUNOLOGY | - |
dc.citation.volume | 8 | - |
dc.citation.number | 8 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.subject.keywordPlus | MODIFIED RECIST MRECIST | - |
dc.subject.keywordPlus | 2ND-LINE TREATMENT | - |
dc.subject.keywordPlus | CLINICAL-TRIAL | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | CANCER | - |
dc.subject.keywordPlus | JX-594 | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | PLACEBO | - |
dc.subject.keywordPlus | HEPATITIS | - |
dc.subject.keywordPlus | TARGETS | - |
dc.subject.keywordAuthor | Hepatocellular carcinoma | - |
dc.subject.keywordAuthor | Pexa-Vec | - |
dc.subject.keywordAuthor | sorafenib | - |
dc.subject.keywordAuthor | oncolytic immunotherapy | - |
dc.subject.keywordAuthor | oncolytic vaccinia | - |
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