Elahere (mirvetuximab soravtansine-gynx)

P3, N=520, Active, not recruiting, AbbVie | Trial primary completion date: May 2032 --> Apr 2027

Platinum-based chemotherapy increased Cyclin-E1 expression. These patients were less likely to benefit from PARP inhibitors (75% are BRCA-wildtype) or mirvetuximab-soravtansine (67% were not FRα-high), highlighting a distinct patient population in need of novel therapies.

P2, N=110, Recruiting, AbbVie | Trial primary completion date: Mar 2028 --> Jul 2026

P3, N=520, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | Trial primary completion date: Apr 2027 --> May 2032

Cataracts represent an under-recognized ocular adverse event associated with mirvetuximab soravtansine-gynx treatment. Although the etiology remains unclear, potentially related to mirvetuximab soravtansine-gynx exposure, ocular corticosteroids, or both, the frequency and tempo observed in this cohort underscore the need for close ophthalmologic monitoring. However, it is reassuring that cataracts can be treated with a minimally invasive procedure with generally excellent outcomes. Further research is warranted to elucidate underlying mechanisms and optimize supportive eye care strategies.

MIRV showed anticipated pharmacokinetics, safety, tolerability, and efficacy profiles in Chinese patients with FRα-positive platinum-resistant ovarian cancers, supporting its potential as a targeted therapeutic agent for this patient population.

MIRV is highly likely to be a more effective treatment option than the chemotherapies currently available for patients with FRα-positive, platinum-resistant ovarian cancer, as approximately 75-90% of ovarian cancers are FRα-positive. However, in the current circumstances, MIRV is unlikely to be considered cost-effective within the German healthcare context without reduction in the drug price.

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.

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.

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.