AbbVie(US:ABBV) Prnewswire·2024-06-06 12:45Group 1 - AbbVie announced positive topline results from the Phase 2 PICCOLO trial for mirvetuximab soravtansine (ELAHERE®) in patients with platinum-sensitive ovarian cancer, achieving an objective response rate (ORR) of 51.9% [1] - The median duration of response (DOR) was reported at 8.25 months, indicating promising efficacy [1] - The safety profile of mirvetuximab soravtansine was consistent with previous studies, with no new safety concerns identified [1] Group 2 - The PICCOLO trial is a single-arm Phase 2 study focusing on patients with high folate receptor-alpha (FRα) positive platinum-sensitive ovarian cancer who have undergone at least two prior lines of platinum therapy [3] - The trial was designed to statistically rule out an ORR of 28% or lower, which is the response rate observed with non-platinum, single-agent chemotherapy in similar patient populations [3] - There is a significant unmet need for effective treatments in this patient group, as subsequent lines of therapy often show decreased efficacy and tolerability [2] Group 3 - Mirvetuximab soravtansine is also being evaluated in the Phase 3 GLORIOSA trial, which studies its combination with bevacizumab versus bevacizumab alone in maintenance therapy after second-line platinum-doublet therapy [4] - Ovarian cancer remains the leading cause of death from gynecological cancers in the U.S., with approximately 20,000 new diagnoses each year [5] - Patients who relapse after platinum-based chemotherapy are classified as either platinum-sensitive or platinum-resistant, impacting treatment options and outcomes [5][6] Group 4 - Mirvetuximab soravtansine is a first-in-class antibody-drug conjugate (ADC) designed to target and kill cancer cells expressing folate receptor alpha [7] - The drug has received regulatory approval in the U.S. for treating FRα positive, platinum-resistant ovarian cancer and is under review in Europe and other countries [8]