FORWARD I: a Phase III study of mirvetuximab soravtansine versus chemotherapy in platinum-resistant ovarian cancer.

Abstract

Mirvetuximab soravtansine, an antibody-drug conjugate that binds with high affinity to folate receptor-α to provide tumor-directed delivery of the potent microtubule-disrupting agent DM4, has emerged as a promising investigational agent for the treatment of ovarian cancer, particularly in the setting of platinum-resistant disease. Here we describe the rationale and design of FORWARD I (NCT02631876), the first randomized, multicenter Phase III study to compare the safety and efficacy of mirvetuximab soravtansine versus investigator's choice of chemotherapy in women with folate receptor-α-positive, platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancer. Patients will be randomized in a 2:1 ratio. The primary end point is progression-free survival, and key secondary objectives include comparison of overall response rates, overall survival and duration of response.

• Authors: Kathleen N Moore, Ignace Vergote, Ana Oaknin, Nicoletta Colombo, Susana Banerjee, Amit Oza, Patricia Pautier, Karim Malek, Michael J Birrer
• Journal: Future oncology (London, England) (Future Oncol) Vol. 14 Issue 17 Pg. 1669-1678 (Jul 2018) ISSN: 1744-8301 [Electronic] England
• PMID: 29424243 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal, Humanized
• Immunoconjugates
• Maytansine
• Platinum
• mirvetuximab soravtansine

Topics

• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carcinoma, Ovarian Epithelial
• Drug Resistance, Neoplasm (drug effects)
• Female
• Follow-Up Studies
• Humans
• Immunoconjugates (therapeutic use)
• Maytansine (analogs & derivatives, therapeutic use)
• Neoplasms, Glandular and Epithelial (drug therapy)
• Ovarian Neoplasms (drug therapy)
• Platinum (pharmacology)
• Prognosis
• Survival Rate