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Poster display session

3202 - FORWARD I: A phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRa)-positive, platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer

Date

09 Sep 2017

Session

Poster display session

Presenters

Kathleen Moore

Citation

Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372

Authors

K.N. Moore1, I. Vergote2, A. Oaknin3, N. Colombo4, S. Banerjee5, A.M. Oza6, P. Pautier7, C.M. Kelly8, K. Malek9, M.J. Birrer10

Author affiliations

  • 1 Obstetrics And Gynecology, Stephenson Cancer Center/University of Oklahoma, 73104 - Oklahoma City/US
  • 2 Gynaecologie-verloskunde, University Hospital Leuven, 3000 - Leuven/BE
  • 3 Medical Oncology Department, Vall d'Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 4 Department Of Gynecological Oncology, Istituto Europeo di Oncologia, 20141 - Milan/IT
  • 5 Gynaecology Unit, The Royal Marsden, SW3 6JJ - London/GB
  • 6 Division Of Medical Oncology And Hematology, Princess Margaret Cancer Centre, M5G 1Z5 - Toronto/CA
  • 7 Medical Oncology, Gustave Roussy Institut de Cancérologie, 94805 - Villejuif/FR
  • 8 Medical Oncology, Mater Misericordiae University Hospital University College Dublin, 7 - Dublin/IE
  • 9 Clinical Development, ImmunoGen, Inc, 02451 - Waltham/US
  • 10 Gynecologic Oncology, Massachusetts General Hospital, 2114 - Boston/US
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Resources

Abstract 3202

Background

Elevated FRa expression is characteristic of a number of solid tumors, including epithelial ovarian cancer (EOC), thus providing an attractive candidate for targeted therapeutic approaches. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC) comprising a potent cytotoxic effector molecule, the tubulin-disrupting maytansinoid DM4, linked to a humanized anti-FRa monoclonal antibody. In a recently completed phase 1 trial in heavily pre-treated ovarian cancer patients, mirvetuximab soravtansine showed a favorable safety profile and promising single-agent clinical activity.

Trial design

FORWARD I is a randomized phase 3 study designed to evaluate the efficacy of mirvetuximab soravtansine compared to standard-of-care chemotherapy in adult patients with platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer. Inclusion criteria include confirmation of tumor FRa positivity by immunohistochemistry (medium or high receptor expression; ≥ 50% of cells with at least moderate staining intensity) and ≤ 3 prior lines of therapy. A total of 333 patients are expected to be recruited, who will be randomized 2:1 to mirvetuximab soravtansine dosed intravenously at 6.0 mg/kg, calculated according to adjusted ideal body weight, on Day 1 of a 21-day cycle or investigators’ choice chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). Progression-free survival (PFS; assessed by blinded independent central review) is the primary efficacy endpoint; secondary endpoints include objective response rate, quality of life, overall survival, safety and tolerability, and duration of response. The first patient enrolled in January 2017.

Clinical trial identification

NCT02631876

Legal entity responsible for the study

ImmunoGen, Inc.

Funding

ImmunoGen, Inc

Disclosure

K.N. Moore, I. Vergote: Advisory board service for ImmunoGen, Inc. K. Malek: Employed by ImmunoGen, Inc. M.J. Birrer: Advisory board service for ImmunoGen, Inc. All other authors have declared no conflicts of interest.

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