Ocular toxicity and safety profile of mirvetuximab soravtansine in ovarian cancer: A systematic review and meta-analysis of clinical trials and real-world studies.

5558 Background: Mirvetuximab soravtansine (MIRV) is a folate receptor alpha (FRα)–targeting antibody–drug conjugate approved for FRα-positive, platinum-resistant ovarian cancer. Ocular adverse events are a characteristic toxicity of MIRV; however, the incidence and severity of ocular and selected non-ocular toxicities across clinical trials and real-world studies have not been comprehensively synthesized. Methods: This systematic review and meta-analysis study was conducted according to PRISMA guidelines and registered in PROSPERO (CRD420251270297). MEDLINE/PubMed, Embase, Scopus, and CENTRAL were searched from inception through December 2025 for prospective phase I–III trials and real-world observational studies evaluating MIRV in epithelial ovarian, fallopian tube, or primary peritoneal cancer. Two reviewers independently screened studies and extracted data. Primary outcomes included any-grade and grade ≥3 ocular adverse events, as well as ocular toxicity–related dose reductions and treatment discontinuations. Secondary outcomes included grade ≥3 pneumonitis and thrombocytopenia. Clinical trial and real-world data were analyzed separately. Random-effects meta-analyses of proportions were performed using logit transformation, with heterogeneity assessed using the I² statistic. Analyses were conducted in R version 4.5.2. Results: Fourteen studies comprising approximately 750 patients were included. In pooled analyses of clinical trials, any-grade ocular adverse events were common (56.2%; 95% CI, 5.2–96.8) with substantial heterogeneity contributing to wide confidence intervals, whereas grade ≥3 ocular adverse events were rare (1.41%; 95% CI, 0.47–4.13) with no observed heterogeneity. Dose reduction due to ocular toxicity occurred in 31.2% (95% CI, 18.0–48.4) of patients, while treatment discontinuation due to ocular adverse events was less frequent (9.98%; 95% CI, 0.70–63.58). Severe non-ocular toxicities were uncommon, with pooled incidences of 1.41% (95% CI, 0.47–4.13) for grade ≥3 pneumonitis and 1.44% (95% CI, 0.09–19.44) for grade ≥3 thrombocytopenia. Across three real-world studies involving 289 patients, treatment discontinuation due to ocular adverse events was rare (0.35%; 95% CI, 0.00–20.54), with safety findings consistent with those from clinical trials. Conclusions: MIRV is associated with frequent, but predominantly low-grade, ocular adverse events, which are commonly managed with dose modification, while severe ocular and non-ocular toxicities are rare. Real-world evidence supports the tolerability profile observed in clinical trials, highlighting the importance of proactive ocular monitoring to optimize treatment continuity.