Mirvetuximab soravtansine 100mg/20ml solution for infusion vials

BackgroundMirvetuximab soravtansine (MIRV) is an antibody-drug conjugate comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent. The randomized, open-label, phase III study FORWARD I compared MIRV and investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian cancer (EOC).Patients and methodsEligible patients with 1-3 prior lines of therapy and whose tumors were positive for FRα expression were randomly assigned, in a 2 : 1 ratio, to receive MIRV (6 mg/kg, adjusted ideal body weight) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary endpoint was progression-free survival [PFS, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, blinded independent central review] in the intention-to-treat (ITT) population and in the prespecified FRα high population.ResultsA total of 366 patients were randomized; 243 received MIRV and 109 received chemotherapy. The primary endpoint, PFS, did not reach statistical significance in either the ITT [hazard ratio (HR), 0.98, P = 0.897] or the FRα high population (HR, 0.69, P = 0.049). Superior outcomes for MIRV over chemotherapy were observed in all secondary endpoints in the FRα high population including improved objective response rate (24% versus 10%), CA-125 responses (53% versus 25%), and patient-reported outcomes (27% versus 13%). Fewer treatment-related grade 3 or higher adverse events (25.1% versus 44.0%), and fewer events leading to dose reduction (19.8% versus 30.3%) and treatment discontinuation (4.5% versus 8.3%) were seen with MIRV compared with chemotherapy.ConclusionsIn patients with platinum-resistant EOC, MIRV did not result in a significant improvement in PFS compared with chemotherapy. Secondary endpoints consistently favored MIRV, particularly in patients with high FRα expression. MIRV showed a differentiated and more manageable safety profile than chemotherapy.

Abstract licence: CC BY-NC-ND

Background Mirvetuximab Soravtansine (MIRV) is a promising antibody‒drug conjugate (ADC) that targets folate receptor alpha (FRα), which is overexpressed in several types of solid tumors. In November 2022, MIRV was approved in the USA for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who received 1–3 prior systemic treatment regimens. Therefore, high-quality evidence for its efficacy and safety in different cancers is urgently needed. Methods A systematic search (e.g., PubMed, Embase, Web Of Science, Cochrane Library) was conducted to identify all relevant clinical trials of MIRV alone or in combination with chemo- and/or target-therapies in solid tumors. The primary end-point was median progression-free survival (mPFS). The secondary endpoints were the Objective response rate (ORR) and adverse effects (AEs). A random-effects model was applied. Results The study included nine research studies with a total of 682 patients. The pooled mPFS and pooled ORR were 6.70 months (95% CI 4.54–8.86, I2 = 96.21%) and 36% (95% CI: 28% to 44%, I2 = 76.79%), respectively. Significant differences were observed among intervention regimens and response to platinum. The pooled mPFS of MIRV monotherapy and MIRV+ Bevacizumab (BEV) combined therapy was 4.28 (95% CI 3.90–4.65, I2 = 0.00%) and 7.78 (95% CI 6.62–8.95, I2 = 0.00%), respectively. The pooled ORRs of MIRV monotherapy and MIRV+BEV combined therapy were 25% (95% CI 21%–29%, I2 = 25.20%) and 43% (95% CI 36%–50%, I2 = 0.01%), respectively. The pooled ORRs of the platinum-sensitive, platinum-resistant groups were 59% (95% CI 36%–81%, I2 = 61.88%), 33% (95% CI 25%–40%, I2 = 69.73%), respectively. In addition, we conducted supplementary subgroup analyses to explore the influence of FRα receptor expression levels and the number of prior treatments on treatment outcomes. The most common adverse effects were blurred vision (45.20%), nausea (40.13%), diarrhea (39.52%), fatigue (33.84%) and keratopathy (31.20%). Conclusions MIRV has significant therapeutic effects in solid tumors, especially when combined with BEV. In platinum-tolerant tumors, the efficacy of MIRV is also considerable. Overall, MIRV is relatively safe in solid tumors, and adverse reactions are relatively rare and mild.

Abstract licence: CC BY 4.0

IntroductionThis meta-analysis aims to evaluate the efficacy and safety of mirvetuximab soravtansine (MIRV) in patients with recurrent ovarian cancer, with particular emphasis on those with platinum-resistant disease.MethodA comprehensive search of PubMed, EMBASE, and the Cochrane Library was conducted through August 31, 2025. Data on progression-free survival (PFS), overall response rate (ORR), overall survival (OS), duration of response (DOR), cancer antigen 125 response, and treatment-related adverse events (TRAEs) were extracted and analyzed using meta-analysis to assess the efficacy and safety of MIRV.ResultTwelve studies involving a total of 1112 patients with recurrent ovarian cancer were included in this meta-analysis. The PFS with MIRV was 6.28 months (95% confidence interval CI 5.70-6.87), and the ORR was 0.37 (95% CI 0.34-0.40). Among platinum-resistant patients treated with a combination of MIRV and bevacizumab, the PFS was 7.66 months (95% CI 6.45-8.87), while the ORR reached 0.42 (95% CI, 0.34-0.50). In addition, MIRV achieved an OS of 16.00 months (95% CI 12.36-19.63) and a DOR of 7.69 months (95% CI 6.80-8.58). The overall incidence of TRAEs was 93% (95% CI 92-95), with grade ≥ 3 adverse events occurring in 34% of patients (95% CI 31-37). The most common TRAEs were blurred vision (incidence 0.45; 95% CI, 0.42-0.48), nausea (0.39; 95% CI 0.37-0.42), and diarrhea (0.37; 95% CI 0.34-0.39).ConclusionMIRV demonstrates significant efficacy and an acceptable safety profile in the treatment of recurrent ovarian cancer. Its use in platinum-resistant ovarian cancer with high FRα expression represents a particularly promising Therapeutic approach. Furthermore, the combination of MIRV and bevacizumab shows substantial potential for improving outcomes in patients with platinum-resistant disease.

Abstract licence: CC BY-NC-ND 4.0

Ovarian cancer is a major cause of gynecological cancer mortality, frequently associated with platinum-resistant recurrences. Given the limited efficacy of conventional chemotherapy in this setting, alternative targeted therapeutics are needed. Mirvetuximab soravtansine (MIRV) is an antibody–drug conjugate designed to deliver the cytotoxic maytansinoid DM4 to folate receptor alpha (FRα)-overexpressing cells. This systematic review of PubMed, ClinicalKey, and SpringerLink databases (2019–2026) evaluates five publications across three clinical trials (one phase II, two phase III) encompassing 925 patients with platinum-resistant disease. Notably, the phase III MIRASOL trial demonstrated improved survival outcomes with MIRV over standard chemotherapy, extending median overall survival (16.46 vs. 12.75 months; HR 0.67) and progression-free survival (5.62 vs. 3.98 months; HR 0.65), with an objective response rate (ORR) of 42.3% versus 15.9%. Furthermore, the single-arm phase II SORAYA trial reported an ORR of 32.4% in pretreated patients, including those with prior PARP inhibitor and bevacizumab exposure. Although the preceding FORWARD I trial missed its primary endpoint in the unselected population, its high-FRα subgroup analysis revealed a clinical benefit that influenced subsequent biomarker-driven enrollment strategies. From a safety perspective, MIRV exhibited lower rates of severe neutropenia and anemia than chemotherapy, with toxicities primarily consisting of manageable, reversible ocular events. Ultimately, MIRV serves as a therapeutic option for platinum-resistant, FRα-positive ovarian cancer, offering survival advantages; however, rigorous biomarker-based screening remains necessary to optimize therapeutic outcomes.

Abstract licence: CC BY 4.0

IntroductionThis meta-analysis aims to systematically analyze the efficacy and toxicity of mirvetuximab soravtansine (MIRV) as second-line and above treatment for advanced or recurrent ovarian cancer.MethodsCandidate studies were identified in PubMed, Embase, Cochrane Library, CNKI, and Wanfang databases up to 1 May 2023. Objective response rate (ORR), progression-free survival (PFS), the incidence of adverse events (AEs), and incidence of grade ≥ 3 AEs were extracted and calculated by meta-analysis of merging ratios or mean to describe the efficacy and toxicity of MIRV.ResultsSeven eligible prospective studies were included in this meta-analysis, including 605 patients with advanced ovarian cancer who received second-line or higher therapy. ORR of MIRV was 34.2% (95% confidence interval [CI] 25.0-43.5), and PFS was 5.82 months (95%CI 4.47-7.18). The overall incidence of AEs was 87.4% (95%CI 52.9-100.0) and the incidence of grade ≥ 3 AEs was 27.1% (95%CI 18.9-36.1). The most common AEs were vision blurring, nausea, and diarrhea, with incidence of 46.7% (39.6-53.8), 41.8% (34.0-49.9), and 41.3% (30.4-52.5), respectively.ConclusionsMIRV has definite efficacy and good safety as a novel choice for second-line and above treatment of advanced or recurrent FRα positive ovarian cancer. This may have promising application in patients with platinum-resistant diseases.Prospero registration numberCRD42023428599.

Abstract licence: CC BY-NC-ND