Mirvetuximab soravtansine-gynx (Elahere) received full FDA approval for the treatment of folate receptor alpha–positive (FRα+), platinum-resistant ovarian cancer (PROC) based on findings from the confirmatory phase 3 MIRASOL trial.
Mirvetuximab soravtansine-gynx (Elahere; AbbVie) received full FDA approval for the treatment of folate receptor alpha–positive (FRα+), platinum-resistant ovarian cancer (PROC) following 1 to 3 prior lines of therapy, AbbVie announced in a press release.1
Mirvetuximab soravtansine, an FRα–directed antibody and microtubule inhibitor conjugate, was granted accelerated FDA approval in November 2022 based on results from the SOYAYA study (Study 0417),2 with the conversion to a full approval supported by findings from the confirmatory phase 3 MIRASOL trial (NCT04209855).1
In the randomized, phase 3 MIRASOL trial, 453 patients with FRα+ PROC received either mirvetuximab soravtansine (n = 227) or investigator's choice single-agent chemotherapy (n = 226).3 The main end point was progression-free survival, which was longer in the mirvetuximab soravtansine cohort (5.62 months [95% CI, 4.34-5.95]) compared with the chemotherapy cohort (3.98 months [95% CI, 2.86-4.47]).
Patients in the mirvetuximab soravtansine cohort also experienced significantly longer median overall survival at 16.46 months (95% CI, 14.46-24.57), compared with 12.75 months (95% CI, 10.91-14.36) in the chemotherapy group (HR, 0.67; 95% CI, 0.50-0.89; P = .005).
"As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, [mirvetuximab soravtansine] provides an effective new option for patients with folate receptor alpha positive tumors," Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator, said in a statement.1 "These patients previously had very limited options and [mirvetuximab soravtansine] changes that."
Another key secondary end point was investigator-assessed objective response, which was significantly higher in the mirvetuximab soravtansine group (42.3% [95% CI, 35.8%-49.0%]) vs the chemotherapy group (15.9% [95% CI, 11.4%-21.4%]), which translates to an OR of 3.81 (95% CI, 2.44-5.94; P < .001). Of those who responded to mirvetuximab soravtansine, 5.3% (n = 12) experienced complete response and 37% (n = 84) had a partial response. Among responders in the chemotherapy group, no patients experienced complete response, and 15.9% (n = 36) experienced complete responses.
The incidence of grade 3 or higher adverse events was lower with mirvetuximab soravtansine vs chemotherapy, as was the incidence of discontinuation due to adverse events. The most common adverse reactions occurring in at least 20% of patients were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.
References
1. U.S. Food and Drug Administration (FDA) grants full approval for Elahere (mirvetuximab soravtansine-gynx) for certain ovarian cancer patients. News release. AbbVie. March 22, 2024. Accessed March 22, 2024. https://www.prnewswire.com/news-releases/us-food-and-drug-administration-fda-grants-full-approval-for-elahere-mirvetuximab-soravtansine-gynx-for-certain-ovarian-cancer-patients-302097362.html
2. Joszt L. FDA approves mirvetuximab soravtansine-gynx for platinum-resistant ovarian cancer. AJMC. November 15, 2022. Accessed March 22, 2024. https://www.ajmc.com/view/fda-approves-mirvetuximab-soravtansine-gynx-for-platinum-resistant-ovarian-cancer
3. Moore KN, Angelergues A, Konecny GE, et al. Mirvetuximab soravtansine in FRα-positive, patinum-resistant ovarian cancer. N Engl J Med. 2023;389(23):2162-2174. doi:10.1056/NEJMoa2309169
CMS Medicare Final Rule: Advancing Benefits, Competition, and Consumer Protection
May 7th 2024On this episode of Managed Care Cast, we're talking with Karen Iapoce, senior director of government products and programs at ZeOmega, about the recent CMS final rule on Medicare Part D and Medicare Advantage.
Listen
Following Roe v Wade Overturn, Research Focuses on Male Contraceptives
May 6th 2024Stephanie T. Page, MD, PhD, UW Medicine Diabetes Institute, presented on ongoing research and growing interest in new male contraceptive options, such as an oral pill and a hormonal transdermal gel, at the American Urological Association 2024 Annual Meeting.
Read More
Access Denied: CMS’ Action Hurts Patients With Cancer in Rural America
May 6th 2024CMS rules hindered the access of rural patients with cancer to medically integrated pharmacies in 2023. The authors discuss the impact on equity in health care, emphasizing the need for regulatory change.
Read More