dc.contributor.author | Moore, KN | |
dc.contributor.author | Oza, AM | |
dc.contributor.author | Colombo, N | |
dc.contributor.author | Oaknin, A | |
dc.contributor.author | Scambia, G | |
dc.contributor.author | Lorusso, D | |
dc.contributor.author | Konecny, GE | |
dc.contributor.author | Banerjee, S | |
dc.contributor.author | Murphy, CG | |
dc.contributor.author | Tanyi, JL | |
dc.contributor.author | Hirte, H | |
dc.contributor.author | Konner, JA | |
dc.contributor.author | Lim, PC | |
dc.contributor.author | Prasad-Hayes, M | |
dc.contributor.author | Monk, BJ | |
dc.contributor.author | Pautier, P | |
dc.contributor.author | Wang, J | |
dc.contributor.author | Berkenblit, A | |
dc.contributor.author | Vergote, I | |
dc.contributor.author | Birrer, MJ | |
dc.date.accessioned | 2021-08-12T10:09:44Z | |
dc.date.available | 2021-08-12T10:09:44Z | |
dc.identifier.citation | Annals of oncology : official journal of the European Society for Medical Oncology, 2021, 32 (6), pp. 757 - 765 | |
dc.identifier.issn | 0923-7534 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4748 | |
dc.identifier.eissn | 1569-8041 | |
dc.identifier.doi | 10.1016/j.annonc.2021.02.017 | |
dc.description.abstract | Background 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.format | Print-Electronic | |
dc.format.extent | 757 - 765 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Ovarian Neoplasms | |
dc.subject | Maytansine | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Immunoconjugates | |
dc.subject | Drug Resistance, Neoplasm | |
dc.subject | Female | |
dc.subject | Antibodies, Monoclonal, Humanized | |
dc.subject | Carcinoma, Ovarian Epithelial | |
dc.title | Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2021-02-25 | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1016/j.annonc.2021.02.017 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Annals of oncology : official journal of the European Society for Medical Oncology | |
pubs.issue | 6 | |
pubs.notes | Not 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-status | Published | |
pubs.volume | 32 | |
pubs.embargo.terms | Not known | |
dc.contributor.icrauthor | Banerjee, Susana | |