{"entity":{"id":"soraya","kind":"trial","name":"SORAYA","aka":[],"tldr":"SORAYA showed that mirvetuximab soravtansine, an antibody-drug conjugate aimed at the folate receptor, shrank about a third of platinum-resistant ovarian cancers that had already been treated with bevacizumab, and earned the first approval of a biomarker-directed drug for this setting.","summary":"Platinum-resistant ovarian cancer responds to single-agent chemotherapy in roughly one patient in ten. SORAYA was a single-arm pivotal study of mirvetuximab soravtansine, an antibody against folate receptor alpha carrying a maytansinoid payload, in 106 patients with platinum-resistant high-grade serous ovarian cancer whose tumours had high folate receptor alpha expression and who had received one to three prior lines including bevacizumab. The primary endpoint was objective response rate by investigator.\n\nAbout a third of patients responded, with responses lasting several months and a toxicity profile dominated by reversible ocular events, which require eye examinations and steroid drops. The drug received accelerated approval in the United States in November 2022, and the randomised MIRASOL trial then confirmed a survival benefit over chemotherapy.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT04296890","url":"https://clinicaltrials.gov/study/NCT04296890"}],"tags":["subtype-trials"],"related":[],"cancers":["platinum-resistant-ovarian-cancer","high-grade-serous-ovarian-cancer","ovarian"],"sections":[],"technologies":[],"targets":[],"drugs":["mirvetuximab-soravtansine"],"companies":["abbvie"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["ursula-matulonis"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04296890","phase":"3","setting":"Platinum-resistant high-grade serous ovarian cancer with high folate receptor alpha expression after one to three prior regimens including bevacizumab: single-arm mirvetuximab soravtansine","sponsor":"ImmunoGen (AbbVie)","result":"Objective responses in about a third of patients with folate receptor alpha-high platinum-resistant ovarian cancer; accelerated approval in November 2022.","yearReported":2022,"enrolled":106,"outcomes":[]},"route":"/trials/soraya/","neighbours":{"cancer":[{"id":"high-grade-serous-ovarian-cancer","kind":"cancer","name":"High-grade serous ovarian cancer","route":"/cancers/high-grade-serous-ovarian-cancer/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-resistant-ovarian-cancer","kind":"cancer","name":"Platinum-resistant ovarian cancer","route":"/cancers/platinum-resistant-ovarian-cancer/"}],"drug":[{"id":"mirvetuximab-soravtansine","kind":"drug","name":"Mirvetuximab soravtansine","route":"/drugs/mirvetuximab-soravtansine/"}],"company":[{"id":"abbvie","kind":"company","name":"AbbVie (incl. ImmunoGen, Capstan)","route":"/companies/abbvie/"}],"person":[{"id":"ursula-matulonis","kind":"person","name":"Ursula A. Matulonis","route":"/people/ursula-matulonis/"}]}}