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360 Health-related quality of life in patients with FRα positive platinum-resistant ovarian cancer treated with mirvetuximab soravtansine vs. investigator’s choice chemotherapy: analysis from the phase 3 MIRASOL trial
  1. Yolanda Garcia Garcia1,
  2. Toon Van Gorp2,
  3. Gottfried E Konecny3,
  4. Alexandra Leary4,
  5. Alessandro D Santin5,
  6. Shanthini Mary Crusz6,
  7. Gina Mantia-Smaldone7,
  8. Domenica Lorusso8,
  9. Nicoletta Colombo9,
  10. Jessica Thomes-Pepin10,
  11. Andrzej Roszak11,
  12. Petronella B Ottevanger12,
  13. Mario Beiner13,
  14. David Cibula14,
  15. Charles Leath15,
  16. Lingling Li16,
  17. Michael Method17 and
  18. Kathleen N Moore18
  1. 1Hospital Universitari Parc Taulí, Sabadell, Spain
  2. 2University Hospital Leuven Leuven Cancer Institute, Leuven, Belgium
  3. 3University of California Los Angeles, Los Angeles, USA
  4. 4Department of Adult Medicine, Villejuif, France
  5. 5Institut de Cancérologie Gustave Roussy, New Haven, USA
  6. 6Department of Obstetrics, London, UK
  7. 7Gynecology, Philadelphia, USA
  8. 8and Reproductive Sciences, Rome, Italy
  9. 9Division of Gynecologic Oncology, Milan, Italy
  10. 10Yale School of Medicine, Maplewood, USA
  11. 11Oncology Department, Poznan, Poland
  12. 12St Bartholomew’s Hospital, Nijmegen, The Netherlands
  13. 13Fox Chase Cancer Center, Kfar Saba, Israel
  14. 14Dipartimento Scienze della Salute della Donna, Columbus, USA
  15. 15del Bambino e di Sanita` Pubblica, Birmingham, USA
  16. 16Fondazione Policlinico Universitario Agostino Gemelli, Waltham, USA
  17. 17IRCCS, Waltham, USA
  18. 18Department of Gynecology, Oklahoma City, USA


Introduction/Background Mirvetuximab soravtansine-gynx (MIRV), an antibody-drug conjugate targeting folate receptor-alpha (FRα), is the first novel treatment to demonstrate a benefit in overall survival in platinum-resistant ovarian cancer (PROC) in a phase 3 trial. MIRASOL is the confirmatory, randomized, global phase 3 trial of MIRV vs standard-of-care chemotherapy in patients with PROC. Here we report quality of life (QoL) findings from the MIRASOL trial, measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 instrument.

Methodology 453 patients with FRα positive PROC (Roche FOLR1–2.1 Assay) who received 1–3 prior lines of therapy were randomized 1:1 to MIRV 6 mg/kg, adjusted ideal body weight every 3 weeks or investigator’s choice chemotherapy (ICC) [paclitaxel, pegylated liposomal doxorubicin, or topotecan]. Global health status (GHS), physical functioning (PF), role functioning (RF), and fatigue symptom (FS) subscales were collected. Responder analyses at week 8/9 were analyzed using the Cochran-Mantel-Haenszel (CMH) to test for differences between the MIRV arm and the IC Chemo arm. Change from baseline was analyzed with mixed model repeated measures.

Results Across all subscales, a higher proportion of patients treated with MIRV vs ICC showed improvement at week 8/9 with statistically significant differences across arms in the GHS (22.9% vs 10.4%, p-value = 0.0023), RF (10.1% vs 3.9%, p-value=0.0386), and FS scales (14.3% vs 4.6%, p-value=0.0038). PF was (11.8% vs 5.8%, p-value= 0.0672). Change from baseline scores favored MIRV across all subscales, with statistically significant differences in all subscales at week 8/9, week 15/16, and week 24 (figure 1).

Abstract 360 Figure 1

Change from baseline in EORTC QLQ-C30 subscales score with MIRV versus IC Chemotherapy during the MIRASOL trial. The EORTC QLQ-C30 is a 30-item questionnaire that assesses quality of life in patients with cancer by measuring functional domains, symptoms, and global health status/quality of life (generally focusing on the past week of their life). Higher functional and global health scale scores indicate a perceived better level of functioning. Higher symptom subscale scores represent a higher perceived level of symptom severity. (A) The global health status/quality of life score assesses overall physical condition and quality of life. (B) The physical functioning subscale determines how physically able a person is (eg, ability to perform more strenuous physical activities). (C) The role functioning subscale determines how well a person can do either a job or household chores. (D) The fatigue symptom measurement indicates how severe a person’s feelings of tiredness/weakness are. aDifference in LS mean (vs IC Chemotherapy). Abbreviations: CI, confidence interval; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; FS, fatigue symptoms; GHS/QoL, global health status/quality of life; IC, investigator’s choice; LS, least squares; MIRV, mirvetuximab soravtansine-gynx; PF, physical functioning; RF, role functioning; SE, standard error

Conclusion In the MIRASOL study, patients treated with MIRV maintained HRQoL while deterioration in HRQoL was observed in the ICC arm. The efficacy and safety of MIRV is supported by PRO data from the MIRASOL trial and position MIRV as a new standard of care for pts with FRα positive PROC.

Disclosures N/A.

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