Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer
- Moore, Kathleen N. M.D.
- Angelergues, Antoine M.D.
- Konecny, Gottfried E. M.D.
- García, Yolanda M.D.
- Banerjee, Susana Ph.D.
- Lorusso, Domenica M.D.
- Lee, Jung-Yun M.D.
- Moroney, John W. M.D.
- Colombo, Nicoletta M.D.
- Roszak, Andrzej M.D.
- Tromp, Jacqueline M.D.
- Myers, Tashanna M.D.
- Lee, Jeong-Won M.D.
- Beiner, Mario M.D.
- Cosgrove, Casey M. M.D.
- Cibula, David M.D.
- Martin, Lainie P. M.D.
- Sabatier, Renaud M.D.
- Buscema, Joseph M.D.
- Estévez-García, Purificación M.D.
- Coffman, Lan M.D.
- Nicum, Shibani M.D.
- Duska, Linda R. M.D.
- Pignata, Sandro Ph.D.
- Gálvez, Fernando M.D.
- Wang, Yuemei Ph.D.
- Method, Michael M.D.
- Berkenblit, Anna M.D.
- Roufai, Diana Bello M.D.
- Van Gorp, Toon M.D.
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 ClinicalTrials.gov number, NCT04209855.)
MIRV in FRα-Positive, Platinum-Resistant Ovarian Cancer
Mirvetuximab soravtansine-gynx is an antibody-drug conjugate targeting FRα. Among women with FRα-positive, platinum-resistant ovarian cancer, median overall survival was 16.46 months with MIRV and 12.75 months with chemotherapy.