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532P Analyses of patient-reported outcomes (PROs) with mirvetuximab soravtansine (MIRV) versus standard chemotherapy in the randomized phase III FORWARD I study in ovarian cancer (GOG 3011)

2022; Elsevier BV; Volume: 33; Linguagem: Inglês

10.1016/j.annonc.2022.07.660

1569-8041

K.N. Moore, A.M. Oza, N. Colombo, A. Oaknin, Giovanni Scambia, D. Lorusso, Susana Banerjee, C. Murphy, J. Konner, P. Lim, M. Prasad-Hayes, B.J. Monk, J. Wang, M.J. Birrer, I.B. Vergote,

Ovarian cancer diagnosis and treatment

MIRV, a first-in-class antibody-drug conjugate targeting folate receptor α (FRα), is currently under investigation for the treatment of patients (pts) with platinum-resistant ovarian cancer in the phase 3 clinical trial MIRASOL. Analyses of PROs collected as part of the phase 3 FORWARD I trial informed the collection of PRO data for MIRASOL. PROs from the EORTC-QLQ-OV28 (OV28), EORTC-QLQ-C30 (C30), and FOSI modules were collected during the FORWARD I trial, and preplanned analyses were conducted on data from the intent-to-treat (ITT) and FRα-high populations. To inform future studies, additional exploratory analyses were conducted. In the ITT population, the primary analysis of OV28 gastrointestinal (GI) symptoms demonstrated a statistically significant improvement of ≥15 points at week 8/9 in pts treated with MIRV vs chemotherapy (CTX) (31.7% vs 14.0%; P = 0.0162). The likelihood of GI symptom deterioration was 70% lower with MIRV compared with CTX (P = 0.0007). Analyses of C30 demonstrated a statistically significant benefit in physical functioning for MIRV over CTX (P= 0.0369). There were improvements in the chemotherapy side effects, sexuality, hair loss, pain severity, body image, and a general improvement in ovarian cancer-specific symptoms on the FOSI, for MIRV vs CTX. In the FRα-high population, analysis of OV28 also demonstrated improvement in GI symptoms for MIRV vs CTX, although this did not achieve statistical significance (27.3% vs 13.3%; P = 0.1426). The likelihood of GI symptom deterioration was 80% lower with MIRV compared with CTX (P = 0.0007). Median time to symptom worsening on the OV28 abdominal/GI scale was longer for MIRV vs CTX (4.0 mo vs 2.1 mo; P = 0.0229). Improvements were seen in chemotherapy side effects, sexuality, hair loss, and body image with MIRV vs CTX. Analyses of PROs from FORWARD I support MIRV in favor of CTX in pts with ovarian cancer, including those with high FRα expression, with improvements across a number of QoL measures. With the addition of an anchor assessment, we look to confirm these findings in MIRASOL and to further understand the degree of change in PROs that is meaningful to patients.