The U.S. Meals and Drug Administration (FDA) has granted breakthrough remedy designation to sofetabart mipitecan for grownup sufferers with platinum-resistant epithelial ovarian, fallopian tube or main peritoneal most cancers who beforehand obtained bevacizumab and mirvetuximab soravtansine, Eli Lilly and Firm introduced in a information launch, primarily based on early medical knowledge exhibiting responses throughout all ranges of folate receptor alpha expression.
The designation is meant to assist velocity the event and evaluate of remedies for severe circumstances when preliminary medical proof suggests significant enchancment over out there therapies, in line with the FDA.
Major knowledge that assist the findings of sofetabart mipitecan
The breakthrough remedy designation was primarily based on preliminary outcomes from a part 1a/b examine of sofetabart mipitecan. Preliminary knowledge have been introduced on the 2025 ASCO Annual Assembly in June, with up to date outcomes shared on the 2025 ESMO Congress in October.
Based on Lilly, the early findings confirmed tumor responses in any respect dose ranges studied and throughout all ranges of folate receptor alpha expression. Responses have been additionally noticed in sufferers whose most cancers had progressed following prior remedy with Elahere (mirvetuximab soravtansine).
Investigators reported that the preliminary knowledge recommended a promising tolerability profile. Low charges of interstitial lung illness, peripheral neuropathy and alopecia have been noticed. No vital ocular toxicity was reported within the examine inhabitants.
“Platinum-resistant ovarian most cancers stays probably the most difficult settings in gynecologic oncology, with restricted remedy choices and poor outcomes for sufferers,” Dr. Bhavana Pothuri, professor of Obstetrics/Gynecology and Medication at NYU Grossman College of Medication, NYU Langone Well being and director of Scientific Trials Workplace on the Perlmutter Most cancers Middle, stated within the information launch. “The breakthrough remedy designation and preliminary medical knowledge for sofetabart mipitecan throughout all ranges of FRα expression are encouraging and level to its potential as a significant remedy choice for sufferers.”
Trial particulars
Sofetabart mipitecan is a folate receptor alpha antibody-drug conjugate that makes use of a proprietary linker know-how and an exatecan payload. The remedy was designed to focus on folate receptor alpha throughout all expression ranges.
Following the part 1 findings, sofetabart mipitecan has superior into the part 3 FRAmework-01 examine. The worldwide trial is evaluating the remedy in two settings. One cohort is learning sofetabart mipitecan as a monotherapy in sufferers with platinum-resistant ovarian most cancers. One other cohort is evaluating the remedy together with Avastin (bevacizumab) in sufferers with platinum-sensitive ovarian most cancers.
The FRAmework-01 examine is being performed in partnership with a number of worldwide analysis teams, together with the European Community for Gynaecological Oncological Trial teams, the GOG Basis and the Asia-Pacific Gynecologic Oncology Trials Group.
Lilly acknowledged that the part 3 program goals to review the remedy throughout all ranges of folate receptor expression in sufferers with superior ovarian most cancers.
Security of sofetabart mipitecan
Security observations from the part 1a/b examine indicated that sofetabart mipitecan had a positive tolerability profile within the sufferers handled to this point, in line with the corporate.
Low charges of interstitial lung illness, peripheral neuropathy and alopecia have been reported within the early evaluation. Investigators additionally reported no vital ocular toxicity, an necessary consideration for remedies focusing on folate receptor alpha.
Lilly famous that the findings are primarily based on preliminary knowledge and that ongoing and future research will additional consider each the security and effectiveness of sofetabart mipitecan in bigger affected person populations.
Reference
- “Lilly’s sofetabart mipitecan receives U.S. FDA’s Breakthrough Remedy designation for the remedy of sure sufferers with platinum-resistant ovarian most cancers.” Information Launch. Eli Lilly and Firm. Jan 20, 2026.
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