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2022-RA-660-ESGO Characterization of extended treatment benefit from three phase 1 and 3 clinical trials examining patients with folate receptor alpha-positive recurrent ovarian cancer treated with single-agent mirvetuximab soravtansine
  1. Ana Oaknin1,
  2. Domenica Lorusso2,
  3. Amit Oza3,
  4. Nicoletta Colombo4,
  5. Toon van Gorp5,
  6. David O’Malley6,
  7. Susana Banerjee7,
  8. Conleth Murphy8,
  9. Philipp Harter9,
  10. Gottfried Konecny10,
  11. Marie-Christine Kaminsky11,
  12. Michael Method12,
  13. Jiuzhou Wang12,
  14. Robert L Coleman13,
  15. Michael Birrer14,
  16. Ursula Matulonis15 and
  17. Kathleen Moore16
  1. 1Vall d´Hebron University Hospital, Barcelona, Spain
  2. 2Fondazione IRCCS National Cancer Institute of Milan, Milan, Italy
  3. 3Ontario Institute for Cancer Research, Toronto, ON, Canada
  4. 4Istituto Europeo Oncologia, Milan, Italy
  5. 5University Hospital Leuven, Leuven, Belgium
  6. 6James Cancer Center/The Ohio State University, Columbus, OH
  7. 7The Institute for Cancer Research, London, UK
  8. 8Bon Secours Hospital, Cork, Ireland
  9. 9Kliniken Essen Mitte Evang, Essen, Germany
  10. 10UCLA Health, Los Angeles, CA
  11. 11GINECO/Centre Alexis Vautrin, Nancy, France
  12. 12ImmunoGen Inc., Waltham, MA
  13. 13US Oncology Research, The Woodlands, TX
  14. 14University of Arkansas for Medical Sciences, Little Rock, AR
  15. 15Dana-Farber Cancer Institute, Boston, MA
  16. 16Stephenson Cancer Center/University of Oklahoma, Oklahoma City, OK


Introduction/Background Mirvetuximab soravtansine (MIRV) is a first-in-class antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent that has demonstrated significant antitumor activity in this difficult-to-treat ovarian cancer population. The objective was to characterize the patients with FRα-positive recurrent ovarian cancer who achieved extended treatment benefit ([ETB]; progression-free survival for >12 months) with MIRV monotherapy.

Methodology Retrospective pooled analysis included patients enrolled across three trials: phase 1 first-in-human, phase 3 FORWARD I, and phase 3 SORAYA. Analysis included patients with low, medium, and high FRα expression by immunohistochemistry. All patients received intravenous MIRV at 6 mg/kg, adjusted ideal body weight, every three weeks until disease progression or unacceptable toxicity.

Results Of the 464 patients included in the analysis, 40 ETB patients were identified: median age 63 years, median of one prior therapy, 52.5% with prior PARPi, and 60% with prior bevacizumab. ETB patients had an overall response rate of 75.0%, with 9 (22.5%) achieving a complete response and 21 (52.5%) achieving a partial response by RECIST v1.1 and demonstrated a median duration of response of 22.1 months (95% CI, 13.8–60.0; interquartile range 13.5–60.0). The most common treatment-related adverse events (TRAEs) (all grade, grade 3+) included blurred vision (60%, 0%), fatigue (50%, 2.5%), nausea (50%, 0%), and keratopathy (40%, 2.5%). Peripheral neuropathy was present in 35% (no grade 3+) and pneumonitis was present in 20% (no grade 3+). TRAEs led to dose delay or reduction in 65% and 47.5% of ETB patients, respectively, and discontinuation in six patients.

Conclusion In a pooled analysis of 464 patients, MIRV monotherapy demonstrated ETB in ~10% patients. The safety profile consisted primarily of low-grade gastrointestinal and ocular events and reinforces MIRV’s potential to become a new standard of care for FRα-positive ovarian cancer.

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