P2/3, N=311, Not yet recruiting, Eli Lilly & Co.

To our knowledge, no published studies or case reports have yet documented central nervous system activity of mirvetuximab soravtansine in ovarian cancer. This case highlights a potential new therapeutic role for this agent in patients with ovarian cancer and central nervous system involvement and underscores the need for prospective clinical trials to rigorously assess its central nervous system penetration and efficacy in larger patient cohorts.

Mirvetuximab soravtansine (MIRV), which targets folate receptor-1 (FOLR1), is FDA-approved for platinum-resistant tubo-ovarian cancers with ≥75% moderate/strong staining, and emerging studies show meaningful responses to MIRV combination therapy even at lower FOLR1 expression. FOLR1 met current MIRV treatment criteria in one case, while ten others showed expression ranging from 5% to 70%. Although most tumors did not meet current biomarker thresholds for Trastuzumab or MIRV monotherapy, detectable expression supports exploring anti-HER2 T-Dxd and MIRV combination treatments in selected MA/MLA cases.

P3, N=660, Recruiting, Genmab | Trial completion date: Feb 2029 --> Nov 2029 | Trial primary completion date: Nov 2028 --> Aug 2029

P2, N=160, Recruiting, Genmab | Not yet recruiting --> Recruiting

We report a 65-year-old patient with heavily pretreated, FRα-positive ovarian cancer who developed therapy-related myelodysplastic syndrome with increased blasts (MDS-IB2, DNMT3A-mutated) during therapy with MIRV in combination with carboplatin having received prior PARPi maintenance therapy. This case demonstrates that MIRV can be safely and effectively administered alongside azacitidine, providing clinically meaningful tumor control without compromising hematologic outcomes. These findings support the concurrent management of ovarian cancer and therapy-related MDS as a viable and underutilized treatment approach in a highly challenging clinical setting.

P3, N=688, Not yet recruiting, Genmab

The results demonstrated significantly higher uptake in CAL51 models compared to MDA-MB-231 models (17.17 ± 2.24%ID/g vs 3.79 ± 1.15%ID/g, P < 0.001), which was further confirmed by subsequent immunohistochemical analysis. In conclusion, 89Zr-DFO-Mirvetuximab holds significant potential for noninvasively identifying TNBC patients with sufficient FRα expression for targeted therapies like Mirvetuximab soravtansine, thereby supporting improved patient stratification and treatment response monitoring.

P1, N=495, Recruiting, Eli Lilly and Company | N=223 --> 495

P3, N=1100, Recruiting, AstraZeneca | N=309 --> 1100

P2, N=240, Recruiting, Genmab | N=107 --> 240

In conclusion, NFTs show an age-dependent FOLR1 expression pattern, which likely reflects hormonal repression of FOLR1 in premenopausal women. NFT tissue from postmenopausal women is appropriate and meets the requirements for the current FOLR1 CDx assay.