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Proffered Paper 2 – Gynaecological cancers

4093 - FORWARD I (GOG 3011): A Phase III study of mirvetuximab soravtansine, a folate receptor alpha (FRa)-targeting antibody-drug conjugate (ADC), versus chemotherapy in patients (pts) with platinum-resistant ovarian cancer (PROC)

Date

29 Sep 2019

Session

Proffered Paper 2 – Gynaecological cancers

Presenters

Kathleen Moore

Citation

Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250

Authors

K.N. Moore1, A.M. Oza2, N. Colombo3, A. Oaknin4, G. Scambia5, D. Lorusso6, R. Farias-Eisner7, S. Banerjee8, C.G. Murphy9, J.L. Tanyi10, H. Hirte11, J.A. Konner12, P.C. Lim13, M. Prasad Hayes14, B.J. Monk15, S.K. Kim16, J. Wang17, P. Pautier18, I.B. Vergote19, M.J. Birrer20

Author affiliations

  • 1 Department Of Obstetrics And Gynecology University, Stephenson Cancer Center/University of Oklahoma, 73104 - Oklahoma City/US
  • 2 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto/CA
  • 3 Department Of Gynecologic Oncology, European Institute of Oncology and University of Milan-Bicocca, Milan/IT
  • 4 Medical Oncology Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona/ES
  • 5 -, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, Rome/IT
  • 6 Gynecologic Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 7 Department Of Obstetrics And Gynecology, University of California at Los Angeles, Los Angeles/US
  • 8 Gynaecology, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 9 Medical Oncology, Bon Secours Hospital, T12 DV56 - Cork/IE
  • 10 Obstetrics And Gynecology, University of Pennsylvania, Philadelphia/US
  • 11 Oncology, Juravinski Cancer Centre, L8V 5C2 - Hamilton/CA
  • 12 Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York/US
  • 13 Gynecologic Oncology, The Center of Hope, Reno/US
  • 14 Obstetrics And Gynecology, Icahn School of Medicine at Mount Sinai, New York/US
  • 15 Gynecologic Oncology, Arizona Oncology, University of Arizona, College of Medicine, Creighton University School of Medicine at St. Joseph’s Hospital, Phoenix/US
  • 16 Mcgovern Medical School, University of Texas, Houston/US
  • 17 Clinical Development, ImmunoGen Inc., Waltham/US
  • 18 Medecine, Gustave Roussy, 94805 - Villejuif/FR
  • 19 Gynaecology, University Hospitals Leuven - Campus Gasthuisberg, 3000 - Leuven/BE
  • 20 Comprehensive Cancer Center, University of Alabama at Birmingham, 35294-3300 - Birmingham/US
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Resources

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Abstract 4093

Background

Mirvetuximab soravtansine (MIRV) is an ADC comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. FORWARD I, a phase III study, evaluated the safety and efficacy of MIRV compared to chemotherapy in pts with PROC.

Methods

Pts with PROC, 1-3 prior lines of therapy, and FRα positivity by immunohistochemistry (stratified by predefined medium or high expression) were enrolled. Pts were randomized 2:1 to MIRV (6 mg/kg, adjusted ideal body weight) once every 21 days or investigators’ choice chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary endpoint was progression-free survival (PFS) by blinded independent review committee, in both the intention-to-treat (ITT) population (medium and high FRα expression) and, separately, in pts with high FRα. Secondary endpoints included objective response rate (ORR) and overall survival (OS). Median follow-up time was 12.5 months.

Results

Of 366 pts randomized, 248 received MIRV and 118 chemotherapy. Baseline characteristics were well balanced across arms. In the ITT population, the PFS hazard ratio (HR) was 0.981 (median PFS of 4.1 vs 4.4 months for MIRV and chemotherapy, respectively). For the high FRα pt subset (n = 218), additional outcomes favored MIRV over chemotherapy: PFS HR of 0.693 (4.8 vs 3.3 months; p = 0.049, not significant by Hochberg procedure), ORR (24% vs 10%), and interim OS (83/213 events (34%); median not reached vs 11.8 months; HR, 0.618). The most common adverse events (AEs) observed with MIRV were nausea (54%), diarrhea (44%), and blurred vision (43%). Fewer high grade (≥ 3) events, dose modifications, and discontinuations due to AEs were seen with MIRV.

Conclusions

While the study did not meet the primary endpoint, promising and consistent efficacy measures were observed in the predefined subset of high FRα PROC pts treated with MIRV. Along with favorable tolerability and differentiated safety, these findings suggest a favorable benefit-risk profile for MIRV in this biomarker-defined and difficult-to-treat population.

Clinical trial identification

NCT02631876.

Editorial acknowledgement

Legal entity responsible for the study

ImmunoGen, Inc.

Funding

ImmunoGen, Inc.

Disclosure

K.N. Moore: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Clovis; Advisory / Consultancy: ImmunoGen; Advisory / Consultancy: Genentech/Roche; Advisory / Consultancy: Tesaro; Advisory / Consultancy: VBL Therapeutics; Advisory / Consultancy: Aravive. A. Oaknin: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy, Travel / Accommodation / Expenses: PharmaMar; Advisory / Consultancy, Travel / Accommodation / Expenses: Clovis; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro; Advisory / Consultancy: ImmunoGen. D. Lorusso: Advisory / Consultancy, Research grant / Funding (institution): Tesaro; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy, Research grant / Funding (institution): Clovis; Advisory / Consultancy: Merrimack. C.G. Murphy: Advisory / Consultancy: Janssen; Advisory / Consultancy: Roche; Advisory / Consultancy: Nordic Pharma; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Pfizer. J.A. Konner: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Clovis; Advisory / Consultancy: ImmunoGen. M. Prasad Hayes: Research grant / Funding (institution): AstraZeneca. S.K. Kim: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: AbbVie; Advisory / Consultancy: Cytomx; Advisory / Consultancy: ImmunoGen; Advisory / Consultancy: Seattle Genetics; Advisory / Consultancy, Travel / Accommodation / Expenses: Astellas/Agensys. J. Wang: Full / Part-time employment: ImmunoGen Inc. P. Pautier: Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Clovis; Advisory / Consultancy, Travel / Accommodation / Expenses: Tesaro. M.J. Birrer: Advisory / Consultancy: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: Merck Sharp & Dome; Advisory / Consultancy: Genentech USA; Advisory / Consultancy: AstraZeneca. All other authors have declared no conflicts of interest.

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