Date: 2017-01-26
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: immunogen (USA - MA)
Product: IMGN853 - mirvetuximab soravtansine
Action
mechanism: antibody drug conjugate (ADC). Mirvetuximab soravtansine (IMGN853) is a FRalpha-targeting antibody drug conjugate (ADC) developed and wholly owned by ImmunoGen. It is the first and only ADC to this target to enter clinical testing, and comprises a FRalpha-binding antibody conjugated to DM4, a potent cancer-cell killing agent developed by ImmunoGen specifically for use in ADCs. The antibody serves to target the DM4 specifically to FRalpha-positive cancer cells which the DM4 can then kill. FRalpha is highly expressed on many cases of epithelial ovarian cancer, and on other types of solid tumors including endometrial cancer and some non-small cell lung cancers. Mirvetuximab soravtansine is currently being assessed for the treatment of FRalpha-positive, platinum-resistant ovarian cancer and for FRalpha-positive relapsed/refractory endometrial cancer, with additional assessments anticipated.
Disease: epithelial ovarian cancer, primary peritoneal carcinoma, Fallopian tube cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: FORWARD I is a Phase 3 trial in which 333 patients will be randomized 2:1 to receive either mirvetuximab soravtansine or the physician's choice of single-agent chemotherapy (pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel). Eligible patients will have been diagnosed with platinum-resistant ovarian cancer that expresses medium or high levels of FR? and will have been treated with up to three prior regimens. The primary endpoint of this study is progression free survival (PFS), which will be assessed in the entire study population and in the subset of patients with high FR? expression. ImmunoGen estimates that 12,000-14,000 patients per year in the U.S. meet these criteria, with a comparable number in the major markets in Europe . (NCT02631876)
Latest
news: * On January 26, 2017, ImmunoGen announced that the first patient has been dosed in FORWARD I, the Company's Phase 3 clinical trial evaluating mirvetuximab soravtansine as a single-agent therapy for the treatment of platinum-resistant ovarian cancer.
* On November 8, 2015, Immunogen announced that the FORWARD I trial will assess mirvetuximab soravtansine as single-agent therapy for the treatment of ovarian cancer previously treated with three to four prior regimens. Patients will have medium or high expression of FR? to qualify for enrollment in this Phase 2 study. Patient enrollment is expected to start in late 2015.
