Rationale for the Study Population Sample Clauses

Rationale for the Study Population. The study population included in this study was initially based on clinical observations from a Phase 1 study of MIRV (Study IMGN853-0401), which showed promising clinical activity in patients with PROC. Results from that study suggested that higher FRα levels correlated with response to treatment (Xxxxxx 2015). Based on those results, a large, randomized Phase 3 study in patients with platinum-resistant advanced high-grade EOC, primary peritoneal, or fallopian tube cancers was initiated. Eligible patients were required to have tumors expressing what was considered a medium or high level FRα expression per the Ventana IHC assay using a newly implemented “10x” scoring method. Results from this study showed that while the study did not meet the primary endpoint per Xxxxxxxx procedure, MIRV showed consistently favorable efficacy when compared to IC Chemo in measures of PFS, XXX, OS, DOR, PFS2, CA-125, and PRO endpoints in patients high FRα expression. Subsequent review demonstrated that the “10x” scoring method for the FOLR1 IHC assay misclassified a significant percentage of patients, and thus further impacted the study results. Ad hoc analyses of the PS2+ high FRα patients revealed enhanced benefit from MIRV for XXX, PFS and OS compared to IC Chemo controls. These findings warranted a follow-up study focusing solely on patients with high FRα expression using the original “PS2+” scoring method. Thus, the present study will enroll a similar PROC population to the prior Phase 3 study, with the exception that patients are required to have high FRα expression by PS2+ scoring as determined by the Ventana FOLR1 (FOLR-2.1) CDx assay. Please refer to the Investigator Xxxxxxxx for more details on the Ventana FOLR1 assay and the FRα expression threshold selected for this study.
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