Mirvetuximab soravtansine-gynx extends survival for certain women with ovarian cancer
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Mirvetuximab soravtansine-gynx conferred a 33% reduction in risk for death compared with chemotherapy for women with folate receptor alpha-positive platinum-resistant ovarian cancer, according to topline data from the agent’s manufacturer.
Results of the phase 3 MIRASOL trial also showed a similar reduction in risk for disease progression or death and a higher objective response rate with mirvetuximab soravtansine-gynx (Elahere, ImunoGen) vs. investigator’s choice of chemotherapy for these women, who had received one to three previous lines of therapy.
Researchers observed no new safety signals.
“I believe the data from the confirmatory MIRASOL trial are practice-changing,” Kathleen N. Moore, MD, MS, associate director of clinical research and director of the Oklahoma TSET/Sarah Cannon phase 1 program, professor in the section of gynecologic oncology at The University of Oklahoma and MIRASOL principal investigator, said in an ImmunoGen press release. “[Folate receptor-alpha] status is a ‘must know’ for all [patients with ovarian cancer] and, for those with platinum-resistant disease who test positive, I believe Elahere should be their first treatment option.”
Mirvetuximab soravtansine-gynx, a first-in-class antibody-drug conjugate, received FDA accelerated approval in November for women with folate receptor-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received one to three prior systemic treatment regimens. ORR and duration of response data from the SORAYA trial served as the basis for that approval. FDA also approved a companion diagnostic device, the Ventana FOLR1 (FOLR-2.1) RxDx assay (Ventana Medical Systems Inc.), to select women for treatment with the agent.
The MIRASOL trial included 453 women with platinum-resistant ovarian cancer whose tumors had high folate receptor alpha levels as measured with the Ventana assay. Nearly half (47%) had three previous lines of treatment, 39% had two previous lines and 14% had one previous line. Most (62%) had previously received bevacizumab (Avastin, Genentech).
Researchers randomly assigned the women to mirvetuximab soravtansine-gynx or investigator's choice of single-agent chemotherapy, including weekly paclitaxel, pegylated liposomal doxorubicin or topotecan.
PFS according to investigator assessment served as the primary endpoint. Secondary endpoints included ORR and OS.
Median follow-up for OS was 13.1 months.
Topline results showed median OS of 16.46 months in the mirvetuximab soravtansine-gynx group vs. 12.75 months in the chemotherapy group (HR = 0.67; P = .0046), median PFS of 5.62 months vs. 3.98 months (HR = 0.65; P < .0001), and an investigator-assessed ORR of 42.3%, including 12 complete responses, vs. 15.9% with no complete responses.
Toxicities with mirvetuximab soravtansine-gynx consisted primarily of low-grade ocular and gastrointestinal events. The agent includes a boxed warning for ocular toxicity.
The mirvetuximab soravtansine-gynx group had lower rates of grade 3 or greater treatment-emergent adverse events (42% vs. 54%), serious adverse events (24% vs. 33%) and treatment-emergent adverse events leading to drug discontinuation (9% vs. 16%).
“Importantly, Elahere is the first drug to show an overall survival benefit in this patient population,” Anna Berkenblit, MD, senior vice president and chief medical officer of ImmunoGen, said in the press release. “These results are remarkable and we extend our appreciation to all of the patients and physicians who participated in MIRASOL. We look forward to presenting full data from the trial at a medical meeting later this year.”
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