Efficacy and Safety of Mirvetuximab Soravtansine in Patients With Platinum-Resistant Ovarian Cancer With High Folate Receptor Alpha Expression: Results From the SORAYA Study

• Published in: Journal of clinical oncology Vol. 41; no. 13; pp. 2436 - 2445
• Main Authors: Matulonis, Ursula A., Lorusso, Domenica, Oaknin, Ana, Pignata, Sandro, Dean, Andrew, Denys, Hannelore, Colombo, Nicoletta, Van Gorp, Toon, Konner, Jason A., Marin, Margarita Romeo, Harter, Philipp, Murphy, Conleth G., Wang, Jiuzhou, Noble, Elizabeth, Esteves, Brooke, Method, Michael, Coleman, Robert L.
• Format: Journal Article
• Language: English
• Published: United States Wolters Kluwer Health 01.05.2023
• Subjects: Adenosine Diphosphate Ribose - therapeutic use; Antineoplastic Agents - therapeutic use; Bevacizumab - therapeutic use; Carcinoma, Ovarian Epithelial - drug therapy; Female; Folate Receptor 1 - therapeutic use; Humans; Immunoconjugates - adverse effects; ORIGINAL REPORTS; Ovarian Neoplasms - drug therapy; Poly(ADP-ribose) Polymerase Inhibitors - therapeutic use
• ISSN: 0732-183X; 1527-7755; 1527-7755
• DOI: 10.1200/JCO.22.01900

PURPOSESingle-agent chemotherapies have limited activity and considerable toxicity in patients with platinum-resistant epithelial ovarian cancer (PROC). Mirvetuximab soravtansine (MIRV) is an antibody-drug conjugate targeting folate receptor α (FRα). SORAYA is a single-arm, phase II study evaluating efficacy and safety of MIRV in patients with PROC.METHODSSORAYA enrolled FRα-high patients with PROC who had received one to three prior therapies, including required bevacizumab. The primary end point was confirmed objective response rate (ORR) by investigator; duration of response was the key secondary end point.RESULTSOne hundred six patients were enrolled; 105 were evaluable for efficacy. All patients had received prior bevacizumab, 51% had three prior lines of therapy, and 48% received a prior poly ADP-ribose polymerase inhibitor. Median follow-up was 13.4 months. ORR was 32.4% (95% CI, 23.6 to 42.2), including five complete and 29 partial responses. The median duration of response was 6.9 months (95% CI, 5.6 to 9.7). In patients with one to two priors, the ORR by investigator was 35.3% (95% CI, 22.4 to 49.9) and in patients with three priors was 30.2% (95% CI, 18.3 to 44.3). The ORR by investigator was 38.0% (95% CI, 24.7 to 52.8) in patients with prior poly ADP-ribose polymerase inhibitor exposure and 27.5% (95% CI, 15.9 to 41.7) in those without. The most common treatment-related adverse events (all grade and grade 3-4) were blurred vision (41% and 6%), keratopathy (29% and 9%), and nausea (29% and 0%). Treatment-related adverse events led to dose delays, reductions, and discontinuations in 33%, 20%, and 9% of patients, respectively.CONCLUSIONMIRV demonstrated consistent clinically meaningful antitumor activity and favorable tolerability and safety in patients with FRα-high PROC who had received up to three prior therapies, including bevacizumab, representing an important advance for this biomarker-selected population.