David OMalley, Director of Translational and Clinical Research Partnerships; Leader, Clinical Trial Innovation at Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute, shared on LinkedIn:
“Proud to share our first in human results for sofetabart mipitecan (Sofe-M), a novel FRα targeting antibody drug conjugate, now published in Annals of Oncology.
At The James, our team was a leader in US enrollment, and the results became the foundation for multiple phase 3 trials.
In 105 heavily pretreated patients with high grade ovarian cancer (median 5 prior lines):
- Overall response rate of 50.5%, and 58.8% at the 3 mg/kg recommended phase 3 dose
- Responses across all FRα expression levels, including tumors below the threshold for currently approved FRα therapy
- 57.9% response rate in patients previously treated with mirvetuximab
These data supported FDA Breakthrough Therapy Designation and launched the registrational FRAmework-01 program in both platinum resistant and platinum sensitive disease.
This is what Tomorrow’s Therapies Today means at Ohio State University Comprehensive Cancer Center-James Cancer Hospital & Solove Research Institute: our patients gaining access to the next generation of treatment years before it reaches standard practice.
My sincere thanks to the patients and families who made this possible, our research team at OSUCCC-James, Prof. Isabelle Ray-Coquard and our international coauthors, and our partners at Eli Lilly.”
Title: Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study
Authors: I. Ray-Coquard, D.M. O’Malley, A. Oaknin, A. Madariaga, N. Lakhani, W. McKean, A. Perez-Fidalgo, M. Okera, S. Kitano, T. Koyama, J.S. Frenel, G. Curigliano, M.R. Khajawa, M. Cheol Lim, D. Lorusso, V. Pilla Reddy, R.M. Speck, A.M. Gilligan, A.M. Szpurka, M. Manvelyan, B. Pothuri
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