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oai:recercat.cat:11351/128852025-05-03T03:20:28Zcom_2072_378070com_2072_378040col_2072_378092

The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial Secord, Angeles Lewin, Sharyn Murphy, Conleth Barquin, Arantzazu Gálvez Montosa, Fernando Cecere, Sabrina Chiara OAKNIN, ANA Institut Català de la Salut [Alvarez Secord A] Duke Cancer Institute, Duke University School of Medicine, Durham, USA. [Lewin SN] Holy Name Medical Center Regional Cancer Center, Teaneck, USA. [Murphy CG] Bon Secours Hospital Cork, Cork, Ireland. Cancer Trials Ireland, Dublin, Ireland. [Cecere SC] Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy. Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples, Italy. [Barquín A] Gynecological, Genitourinary, and Skin Cancer Unit, Hospital Universitario HM Sanchinarro, Madrid, Spain. [Gálvez-Montosa BF] Medical Oncology Department, Hospital Universitario de Jaén, Jaén, Spain. [Oaknin A] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Avaluació de resultats (Assistència sanitària) Ovaris - Càncer - Tractament Anticossos monoclonals - Ús terapèutic ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Ovarian Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Serum Globulins::Immunoglobulins::Antibodies::Immunoconjugates Other subheadings::Other subheadings::/therapeutic use TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias ováricas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::globulinas séricas::inmunoglobulinas::anticuerpos::inmunoconjugados Otros calificadores::Otros calificadores::/uso terapéutico Antibody–drug conjugate; Folate receptor alpha; Platinum-sensitive ovarian cancer Conjugado anticuerpo-fármaco; Receptor de folato alfa; Cáncer de ovario sensible al platino Conjugat anticòs-fàrmac; Receptor de folat alfa; Càncer d'ovari sensible al platí Background Mirvetuximab soravtansine-gynx (MIRV) is a first-in-class, folate receptor alpha (FRα)-targeting antibody–drug conjugate with United States Food and Drug Administration approval for FRα-positive platinum-resistant ovarian cancer. PICCOLO is a phase II, global, open-label, single-arm trial of MIRV as third-line or greater (≥3L) treatment in patients with FRα-positive (≥75% of cells with ≥2+ staining intensity) recurrent platinum-sensitive ovarian cancer (PSOC). Patients and methods Participants received MIRV (6 mg/kg adjusted ideal body weight every 3 weeks) until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death. Primary endpoint was investigator-assessed objective response rate (ORR). Key secondary endpoint was investigator-assessed duration of response (DOR). Additional endpoints included investigator-assessed progression-free survival (PFS), overall survival (OS), and safety. Analyses of subgroups by disease characteristics (e.g. platinum-free interval) and treatment history [e.g. prior bevacizumab and poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi) treatment] were exploratory. Results Seventy-nine participants were enrolled and efficacy assessable. The primary endpoint was met; ORR was 51.9% [95% confidence interval (CI) 40.4% to 63.3%]. Median DOR was 8.25 months (95% CI 5.55-10.78 months) and median PFS was 6.93 months (95% CI 5.85-9.59 months). OS was not mature at data cut-off. ORR was 45.8% (95% CI 32.7% to 59.2%) in participants with PD while on/within 30 days of prior PARPi (n = 59) and 60.0% (95% CI 14.7% to 94.7%) in those without PD with prior PARPi (n = 5). No new safety signals occurred; most common treatment-emergent adverse events (TEAEs) were gastrointestinal, neurosensory, and resolvable ocular events. TEAEs led to discontinuation in 13 participants (16%) and death in 2 participants (3%). Conclusions MIRV as ≥3L treatment in heavily pretreated recurrent FRα-positive PSOC demonstrated notable efficacy and tolerable safety, including among those with prior PD on or within 30 days of PARPi (NCT05041257). This work was supported by ImmunoGen, Inc. (no grant number). The sponsor designed, collected, analyzed, and interpreted the trial data in collaboration with the authors. 2025-04-02T12:46:23Z 2025-04-02T12:46:23Z 2025-03 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Alvarez Secord A, Lewin SN, Murphy CG, Cecere SC, Barquín A, Gálvez-Montosa F, et al. The efficacy and safety of mirvetuximab soravtansine in FRα-positive, third-line and later, recurrent platinum-sensitive ovarian cancer: the single-arm phase II PICCOLO trial. Ann Oncol. 2025 Mar;36(3):321-30. 0923-7534 http://hdl.handle.net/11351/12885 10.1016/j.annonc.2024.11.011 39617145 001430364700001 http://hdl.handle.net/11351/12885 eng Annals of Oncology;36(3) https://doi.org/10.1016/j.annonc.2024.11.011 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia