Investigational Rinatabart Sesutecan (Rina-S®) Continues to Show Encouraging Antitumor Activity in Patients with Advanced Ovarian Cancer

Core Insights - Genmab A/S announced promising results from the Phase 1/2 RAINFOL-01 study of rinatabart sesutecan (Rina-S), showing a confirmed objective response rate (ORR) of 55.6% in heavily pre-treated ovarian cancer patients [2][4][8] - The study highlights the potential of Rina-S as a treatment option for patients with platinum-resistant ovarian cancer (PROC), a group with historically poor prognosis [3][6] Company Overview - Genmab is an international biotechnology company focused on developing innovative antibody therapeutics, with a vision to transform cancer treatment by 2030 [13][14] - The company is headquartered in Copenhagen, Denmark, and has a global presence across North America, Europe, and Asia Pacific [14] Study Details - The RAINFOL-01 trial is an open-label, multicenter Phase 1/2 study evaluating the safety and efficacy of Rina-S in solid tumors expressing folate receptor-alpha (FRα) [7] - The B1 cohort specifically targets advanced ovarian cancer, with patients receiving either 100 mg/m or 120 mg/m doses of Rina-S [4][9] Clinical Results - In the B1 cohort, Rina-S at 120 mg/m resulted in a confirmed ORR of 55.6% and a disease control rate (DCR) of 88.9% [4][8] - The median duration of response (mDOR) was not reached, indicating sustained efficacy [4][8] - Common treatment-emergent adverse events included anemia, nausea, and fatigue, but no new safety signals were observed [5][6] Future Directions - Rina-S 120 mg/m has been selected for further evaluation in ongoing Phase 3 trials (RAINFOL-02) for PROC patients [4][11] - The FDA granted Fast Track designation to Rina-S for treating FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer [11]