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New England Journal of Medicine


Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer.

Last Revised:
PMID: 38055253
DOI: 10.1056/NEJMoa2309169


The study was a phase 3, global, randomized trial to compare the efficacy and safety of Mirvetuximab soravtansine-gynx (MIRV) with chemotherapy in treating platinum-resistant, high-grade serous ovarian cancer. Patients with high folate receptor α (FRα) tumor expression were administered either MIRV or standard chemotherapy. Results showed patients treated with MIRV had a longer median progression-free survival of 5.62 months compared to chemotherapy's 3.98 months, and a higher objective response rate. Also, MIRV showed a significant overall survival benefit and fewer adverse events compared to chemotherapy.

Key Takeaways

  • MIRV showed a significantly longer median progression-free survival compared to standard chemotherapy in platinum-resistant, high-grade serous ovarian cancer patients with high FRα tumor expression.
  • Patients treated with MIRV had a higher objective response rate and overall survival compared to those treated with chemotherapy.
  • MIRV treatment recorded fewer adverse events of grade 3 or higher, serious adverse events of any grade, and events leading to discontinuation compared to chemotherapy.

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Kathleen N Moore, Antoine Angelergues, Gottfried E Konecny, Yolanda García, Susana Banerjee, Domenica Lorusso, Jung-Yun Lee, John W Moroney, Nicoletta Colombo, Andrzej Roszak, Jacqueline Tromp, Tashanna Myers, Jeong-Won Lee, Mario Beiner, Casey M Cosgrove, David Cibula, Lainie P Martin, Renaud Sabatier, Joseph Buscema, Purificación Estévez-García, Lan Coffman, Shibani Nicum, Linda R Duska, Sandro Pignata, Fernando Gálvez, Yuemei Wang, Michael Method, Anna Berkenblit, Diana Bello Roufai, Toon Van Gorp,

Full Abstract

  • BACKGROUND: Mirvetuximab soravtansine-gynx (MIRV), a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), is approved for the treatment of platinum-resistant ovarian cancer in the United States.
  • METHODS: We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator's choice of chemotherapy in the treatment of platinum-resistant, high-grade serous ovarian cancer. Participants who had previously received one to three lines of therapy and had high FRα tumor expression (≥75% of cells with ≥2+ staining intensity) were randomly assigned in a 1:1 ratio to receive MIRV (6 mg per kilogram of adjusted ideal body weight every 3 weeks) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary end point was investigator-assessed progression-free survival; key secondary analytic end points included objective response, overall survival, and participant-reported outcomes.
  • RESULTS: A total of 453 participants underwent randomization; 227 were assigned to the MIRV group and 226 to the chemotherapy group. The median progression-free survival was 5.62 months (95% confidence interval [CI], 4.34 to 5.95) with MIRV and 3.98 months (95% CI, 2.86 to 4.47) with chemotherapy (P<0.001). An objective response occurred in 42.3% of the participants in the MIRV group and in 15.9% of those in the chemotherapy group (odds ratio, 3.81; 95% CI, 2.44 to 5.94; P<0.001). Overall survival was significantly longer with MIRV than with chemotherapy (median, 16.46 months vs. 12.75 months; hazard ratio for death, 0.67; 95% CI, 0.50 to 0.89; P = 0.005). During the treatment period, fewer adverse events of grade 3 or higher occurred with MIRV than with chemotherapy (41.7% vs. 54.1%), as did serious adverse events of any grade (23.9% vs. 32.9%) and events leading to discontinuation (9.2% vs. 15.9%).
  • CONCLUSIONS: Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV showed a significant benefit over chemotherapy with respect to progression-free and overall survival and objective response. (Funded by ImmunoGen; MIRASOL number, NCT04209855.).


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