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Cancer. 2017 Aug 15;123(16):3080-3087. doi: 10.1002/cncr.30736. Epub 2017 Apr 25.

Phase 1 dose-escalation study of mirvetuximab soravtansine (IMGN853), a folate receptor α-targeting antibody-drug conjugate, in patients with solid tumors.

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Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.
Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
Department of Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio.
Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, Texas.
Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.
Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, Tennessee.
Division of Hematology/Oncology, University of Kansas, Fairway, Kansas.
Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts.
ImmunoGen, Inc., Waltham, Massachusetts.
Gillette Center for Gynecologic Oncology, Massachusetts General Hospital, Boston, Massachusetts.



Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate that selectively targets folate receptor α (FRα). In this phase 1 dose-escalation study, the authors investigated IMGN853 in patients with FRα-positive solid tumors.


Patients received IMGN853 on day 1 of a 21-day cycle (once every 3 weeks dosing), with cycles repeated until patients experienced dose-limiting toxicity or progression. Dose escalation commenced in single-patient cohorts for the first 4 planned dose levels and then followed a standard 3 + 3 scheme. The primary objectives were to determine the maximum tolerated dose and the recommended phase 2 dose. Secondary objectives were to determine safety and tolerability, to characterize the pharmacokinetic profile, and to describe preliminary clinical activity.


In total, 44 patients received treatment at doses escalating from 0.15 to 7.0 mg/kg. No meaningful drug accumulation was observed with the dosing regimen of once every 3 weeks. The most common treatment-related adverse events were fatigue, blurred vision, and diarrhea, the majority of which were grade 1 or 2. The dose-limiting toxicities observed were grade 3 hypophosphatemia (5.0 mg/kg) and grade 3 punctate keratitis (7.0 mg/kg). Two patients, both of whom were individuals with epithelial ovarian cancer, achieved confirmed tumor responses according to Response Evaluation Criteria in Solid Tumors 1.1, and each was a partial response.


IMGN853 demonstrated a manageable safety profile and encouraging preliminary clinical activity, particularly in patients with ovarian cancer. The results establish a recommended phase 2 dosing of 6.0 mg/kg (based on adjusted ideal body weight) once every 3 weeks. Cancer 2017. © 2017 American Cancer Society. Cancer 2017;123:3080-7. © 2017 American Cancer Society.


antibody-drug conjugate; clinical trial; folate receptor; phase 1; targeted therapy

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