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dc.contributor.authorMoore, KN
dc.contributor.authorOza, AM
dc.contributor.authorColombo, N
dc.contributor.authorOaknin, A
dc.contributor.authorScambia, G
dc.contributor.authorLorusso, D
dc.contributor.authorKonecny, GE
dc.contributor.authorBanerjee, S
dc.contributor.authorMurphy, CG
dc.contributor.authorTanyi, JL
dc.contributor.authorHirte, H
dc.contributor.authorKonner, JA
dc.contributor.authorLim, PC
dc.contributor.authorPrasad-Hayes, M
dc.contributor.authorMonk, BJ
dc.contributor.authorPautier, P
dc.contributor.authorWang, J
dc.contributor.authorBerkenblit, A
dc.contributor.authorVergote, I
dc.contributor.authorBirrer, MJ
dc.date.accessioned2021-08-12T10:09:44Z
dc.date.available2021-08-12T10:09:44Z
dc.identifier.citationAnnals of oncology : official journal of the European Society for Medical Oncology, 2021, 32 (6), pp. 757 - 765
dc.identifier.issn0923-7534
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4748
dc.identifier.eissn1569-8041
dc.identifier.eissn1569-8041en_US
dc.identifier.doi10.1016/j.annonc.2021.02.017
dc.identifier.doi10.1016/j.annonc.2021.02.017en_US
dc.description.abstractBackground Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. The randomized, open-label, phase III study FORWARD I compared MIRV and investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian cancer (EOC).Patients and methods Eligible patients with 1-3 prior lines of therapy and whose tumors were positive for FRα expression were randomly assigned, in a 2 : 1 ratio, to receive MIRV (6 mg/kg, adjusted ideal body weight) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary endpoint was progression-free survival [PFS, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, blinded independent central review] in the intention-to-treat (ITT) population and in the prespecified FRα high population.Results A total of 366 patients were randomized; 243 received MIRV and 109 received chemotherapy. The primary endpoint, PFS, did not reach statistical significance in either the ITT [hazard ratio (HR), 0.98, P = 0.897] or the FRα high population (HR, 0.69, P = 0.049). Superior outcomes for MIRV over chemotherapy were observed in all secondary endpoints in the FRα high population including improved objective response rate (24% versus 10%), CA-125 responses (53% versus 25%), and patient-reported outcomes (27% versus 13%). Fewer treatment-related grade 3 or higher adverse events (25.1% versus 44.0%), and fewer events leading to dose reduction (19.8% versus 30.3%) and treatment discontinuation (4.5% versus 8.3%) were seen with MIRV compared with chemotherapy.Conclusions In patients with platinum-resistant EOC, MIRV did not result in a significant improvement in PFS compared with chemotherapy. Secondary endpoints consistently favored MIRV, particularly in patients with high FRα expression. MIRV showed a differentiated and more manageable safety profile than chemotherapy.
dc.formatPrint-Electronic
dc.format.extent757 - 765
dc.languageeng
dc.language.isoeng
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectHumans
dc.subjectOvarian Neoplasms
dc.subjectMaytansine
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectImmunoconjugates
dc.subjectDrug Resistance, Neoplasm
dc.subjectFemale
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectCarcinoma, Ovarian Epithelial
dc.titlePhase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I.
dc.typeJournal Article
dcterms.dateAccepted2021-02-25
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1016/j.annonc.2021.02.017
dc.relation.isPartOfAnnals of oncology : official journal of the European Society for Medical Oncology
pubs.issue6
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume32en_US
pubs.embargo.termsNot known
dc.contributor.icrauthorBanerjee, Susanaen


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