FORWARD I (GOG 3011): A randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer.

Authors

Kathleen Moore

Kathleen N. Moore

University of Oklahoma Health Sciences Center, Oklahoma City, OK

Kathleen N. Moore , Ignace Vergote , Ana Oaknin , Nicoletta Colombo , Susana N. Banerjee , Amit M. Oza , Patricia Pautier , Catherine Margaret Kelly , Karim S. Malek , Rodrigo Ruiz-Soto , Michael J. Birrer

Organizations

University of Oklahoma Health Sciences Center, Oklahoma City, OK, BGOG and University of Leuven, Leuven Cancer Institute, Leuven, Belgium, Vall d’Hebron University Hospital Institute of Oncology (VHIO), Barcelona, Spain, University of Milano-Bicocca and Istituto Europeo di Oncologia, Milan, Italy, The Royal Marsden NHS Foundation Trust, London, United Kingdom, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, GINECO and Gustave Roussy Cancer Center, Villejuif, France, Cancer Trials Ireland, Dublin, Ireland, ImmunoGen, Inc., Waltham, MA, Massachusetts General Hospital, Boston, MA

Research Funding

Pharmaceutical/Biotech Company

Background: Elevated FRα expression is characteristic of a number of solid tumors, including EOC, thereby providing an attractive candidate for targeted therapeutic approaches. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC), comprising a FRα-binding antibody linked to the tubulin-disrupting maytansinoid DM4, that has shown single agent clinical activity and a favorable safety profile in an ongoing, first-in-human phase 1 trial (NCT01609556). Methods: FORWARD I is a randomized phase 3 study designed to evaluate the efficacy of mirvetuximab soravtansine compared with that of standard-of-care chemotherapy in adult patients with platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer. Confirmation of FRα positivity by immunohistochemistry (medium or high expression; ≥ 50% of cells with at least moderate staining intensity) and ≤ 3 prior lines of therapy are required for inclusion. A maximum of 333 patients are expected to be recruited. Patients will be randomized 2:1 to Arm 1 (intravenous mirvetuximab soravtansine at a dose of 6.0 mg/kg, calculated using adjusted ideal body weight, on Day 1 of a 21-day cycle) or Arm 2 (investigators’ choice chemotherapy: paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary efficacy endpoint is progression-free survival (PFS; by blinded independent central review) and secondary endpoints include objective response rate, quality of life, overall survival, safety and tolerability, and duration of response. The first patient was enrolled in January 2017. Clinical trial information: NCT02631876

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Abstract Details

Meeting

2017 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Ovarian Cancer

Clinical Trial Registration Number

NCT02631876

Citation

J Clin Oncol 35, 2017 (suppl; abstr TPS5607)

DOI

10.1200/JCO.2017.35.15_suppl.TPS5607

Abstract #

TPS5607

Poster Bd #

425b

Abstract Disclosures