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Review
Mirvetuximab soravtansine-gynx: first antibody/antigen-drug conjugate (ADC) in advanced or recurrent ovarian cancer
  1. Giorgio Bogani1,
  2. Robert L Coleman2,
  3. Ignace Vergote3,
  4. Toon van Gorp4,
  5. Isabelle Ray-Coquard5,6,
  6. Ana Oaknin7,
  7. Ursula Matulonis8,
  8. David O’Malley9,
  9. Francesco Raspagliesi10,
  10. Giovanni Scambia11 and
  11. Bradley J Monk12
  1. 1Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy
  2. 2Gynecologic Oncology, Texas Oncology Houston Memorial City, Shenandoah, Texas, USA
  3. 3Department of Gynecology and Obstetrics, Gynecologic Oncology, Leuven Cancer Institute, Catholic University Leuven, Leuven, Belgium
  4. 4Gynaecological Oncology, KU Leuven University Hospitals Leuven, Leuven, Belgium
  5. 5Centre Leon Berard, LYON CEDEX 08, Centre, France
  6. 6Hesper lab, Université Claude Bernard Lyon 1, Villeurbanne, France
  7. 7Vall d'Hebron Institute of Oncology, Barcelona, Spain
  8. 8Dana Farber Cancer Institute, Boston, Massachusetts, USA
  9. 9The Ohio State University Comprehensive Cancer Center Arthur G James Cancer Hospital and Richard J Solove Research Institute, Columbus, Ohio, USA
  10. 10Deparment of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  11. 11Dipartimento Scienze della Salute della Donna e del Bambino, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
  12. 12Virginia G Piper Cancer Center – Biltmore Cancer Center, Phoenix, Arizona, USA
  1. Correspondence to Dr Giorgio Bogani, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy; bogani.giorgio{at}gmail.com

Abstract

Mirvetuximab soravtansine-gynx (MIRV) is a conjugate of a folate receptor alpha (FRα)-directed antibody and the maytansinoid microtubule inhibitor, DM4. Accumulating pre-clinical and clinical data supported the safety and anti-tumor activity of MIRV in tumors expressing FRα. In 2017, a phase I expansion study reported the first experience of MIRV in FRα-positive platinum-resistant ovarian cancer with promising results. However, the phase III FORWARD I study failed to demonstrate a significant benefit of MIRV in FRα-positive tumors. On the basis of the data reported from this latter study, MIRV was then explored in the FRα-high population only and using a different folate receptor assay. The phase II SORAYA trial supported the adoption of MIRV in this setting. Hence, the US Food and Drug Administration granted accelerated approval of MIRV for patients with FRα-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1–3 prior systemic treatment regimens. Moreover, the results of the MIRASOL trial showed a significant reduction in the risk of tumor progression or death among patients treated with MIRV versus chemotherapy. VENTANA FOLR1 (FOLR-2.1) was approved as a companion diagnostic test to identify FRα patients. MIRV appears to be a significant asset in managing advanced or recurrent ovarian cancer. Further trials are needed to confirm these promising results, even in the neoadjuvant, adjuvant, and maintenance settings.

  • Ovarian Cancer

https://doi.org/10.1136/ijgc-2023-004924

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    Footnotes

    • Twitter @BoganiGiorgio, @rcoledude

    • Contributors Conceptualization: GB, BJM. Methodology: all authors. Project administration: BJM. Supervision: IV, RLC, BJM. Writing – original draft: all authors. Writing – review and editing: all authors.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests GB: Consulting/advisory role with Novartis. RLC: Consulting/advisory role: Merck, Genentech/Roche, Paravance, AstraZeneca, Novartis, Genmab, GSK, Gilead, Daiichi-Sankyo, Easai, OncXerna, Immunogen, Mersana, Novocure, Verastem, AbbVie; research funding: AstraZeneca, Clovis, Merck, Roche/Genentech, Abbott/AbbVie, Karyopharm. IV: Consulting fees from Agenus, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F Hoffmann-La Roche, Genmab, GSK, Immunogen, Jazzpharma, Karyopharm, Mersana, MSD, Novocure, Novartis, Oncoinvent, OncXerna, Sanofi, Regeneron, Seagen, Sotio, Verastem Oncology, Zentalis. IRC: Consulting fees from Agenus, Amgen, Akesobio, AstraZeneca, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, F Hoffmann-La Roche, Genmab, GSK, Immunogen, Mersana, MSD, Novocure, Novartis, Netrispharma, OncXerna, Sanofi, Transgene, Seagen, Adaptimmune, Verastem Oncology. AO: Consulting/Advisory role: Roche, AstraZeneca, PharmaMar, Clovis Oncology, Tesaro, ImmunoGen, Genmab, Mersana, GSK, Deciphera, AGENUS, Corcept Therapeutics, Eisai, EMD Serono, Medison, Merck Sharp & Dohme, Novocure, prIME Oncology, Shattuck Labs, Sutro Biopharma, ITeos Therapeutics, Amgen; research funding: AbbVie, Abililty Pharmaceuticals, Advaxis, Aeterna Zentaris, Aprea Therapeutics, Clovis Oncology, Eisai, Roche, Regeneron, Agenus, AstraZeneca, BeiGene, Belgian Gynaecological Oncology Group (BGOG), Bristol Myers Squibb International Corporation (BMS), Corcept Therapeutics, ImmunoGen, Iovance Biotherapeutics, Lilly, Medimmune, Merck, Merck Sharp & Dohme, Mundipharma Research, Novartis FarmacÃutica, Seagen, Seattle Genetics, Sutro Biopharma, Tesaro, Verastem (all payments institutional); travel, accommodations, expenses: AstraZeneca, Clovis Oncology, PharmaMar, Roche. DOM: Consult and/or Advisory Boards: AbbVie, AdaptImmune, Agenus, Arquer Diagnostics, AstraZeneca, Atossa Therapeutics, Boston Biomedical, Cardiff Oncology, Celcuity, Clovis Oncology, Celcuity, Clovis Oncology, Corcept Therapeutics, Duality Bio, Eisai, Elevar, Exelixis, Genentech, Genelux, GlaxoSmithKline, GOG Foundation, Hoffmann-La Roche, ImmunoGen, Imvax, InterVenn, INXMED, IOVANCE Biotherapeutics, Janssen, Jazz Pharmaceuticals, Laekna, Leap Therapeutics, Luzsana Biotechology, Merck & Co, Merck Sharp & Dohme Corp, Mersana Therapeutics, Myriad, Novartis, NovoCure, OncoC4, Onconova, Regeneron Pharmaceuticals, RepImmune, R Pharm, Roche Diagnostics, Seattle Genetics (SeaGen), Sorrento, Sutro Biopharma, Tarveda Therapeutics, Toray, Trillium, Umoja, Verastem, VBL Therapeutics, Vincerx Pharma, Xencor, Zentalis. Institution received funds for research: AbbVie, Advaxis, Agenus, AlkermesAravive, Aravive, Arcus Biosciences, AstraZeneca, BeiGene USA, Boston Biomedical, Bristol Myers Squibb, Clovis Oncology, Deciphera Pharma, Eisai, EMD Serono, Exelixis, Genentech, Genmab, GlaxoSmithKline, GOG Foundation, Hoffmann-La Roche, ImmunoGen, Incyte Corporation, IOVANCE Biotherapeutics, Karyopharm, Leap Therapeutics, Ludwig Institute, Merck & Co, Merck Sharp & Dohme Corp, Mersana Therapeutics, NCI, Novartis, NovoCure, NRG Oncology, OncoC4, OncoQuest, Pfizer, Precision Therapeutics, Prelude Therapeutics, Regeneron Pharmaceuticals, RTOG, Rubius Therapeutics, Seattle Genetics (SeaGen), Sutro Biopharma, SWOG, TESARO, Verastem. FR: Honoraria from GSK, Pharmamar, Clovis, MSD and Roche. UAM: Consulting or advisory fees: NextCure, Allarity, Ovarian Cancer Research Alliance, Pfizer, Profound Bio, Eisai, CureLab, Immunogen, Trillium, Agenus, Novartis, Boerhinger Ingelheim; participation in a Data Safety Monitoring Board: Alkermes, Symphogen; speakers’ bureau: Med Learning Group. TVG: Consulting/advising with AstraZeneca, Eisai, GSK, ImmunoGen, MSD/Merck, OncXerna Therapeutics, Seagen and Tubulis; travel, accommodations, and/or expenses from AstraZeneca, ImmunoGen, MSD/Merck, and PharmaMar; research funding from Amgen, Roche and AstraZeneca. All payments institutional. GS: research funding from MSD/Merck and honoraria from Clovis Oncology; consultant for Tesaro and Johnson & Johnson. BJM: consulting with Agenus, Akeso Bio, Amgen, Aravive, Bayer, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, ImmunoGen, Iovance, Karyopharm, Macrogenics, Mersana, Myriad, Novocure, Novartis, Pfizer, Puma, Regeneron, Sorrento, US Oncology Research, and VBL; speakers’ bureau honoraria from AstraZeneca, Clovis, Eisai, Merck, Roche/Genentech, and Tesaro/GSK.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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