AbbVie Reports Positive Phase 2 Results for Mirvetuximab Soravtansine in Platinum-Sensitive Ovarian Cancer

AbbVie has announced promising top-line results from the Phase 2 PICCOLO trial, which evaluated the investigational monotherapy mirvetuximab soravtansine (ELAHERE®) in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The study achieved its primary endpoint, with an objective response rate (ORR) of 51.9% (95%CI 40.4 – 63.3%). The median duration of response (DOR), a key secondary endpoint, was 8.25 months.

The safety profile of mirvetuximab soravtansine remained consistent with previous studies, with no new safety concerns identified. Comprehensive data from the PICCOLO study will be presented at an upcoming medical meeting. Dr. Angeles Alvarez Secord of the Duke Cancer Institute emphasized the significance of these results, noting the ongoing need for new treatment options for patients with platinum-sensitive disease, as current therapies often become less effective over time.

The PICCOLO trial is a Phase 2, single-arm study focusing on the efficacy and safety of mirvetuximab soravtansine in patients with FRα high platinum-sensitive ovarian cancer who have undergone at least two prior lines of platinum-based therapy or have a documented platinum allergy. The trial aimed to statistically rule out an ORR of 28% or lower, a threshold previously observed with non-platinum, single-agent chemotherapy in PSOC. For patients with multiple prior lines of therapy or those ineligible for platinum-based therapy, as included in the PICCOLO trial population, there is no established benchmark standard of care especially after disease progression on a PARP inhibitor.

Additionally, mirvetuximab soravtansine is under investigation in the Phase 3 GLORIOSA trial for PSOC, in combination with bevacizumab versus bevacizumab alone in maintenance settings post second-line platinum-doublet therapy.

Ovarian cancer remains the leading cause of death among gynecological cancers in the United States, with approximately 20,000 diagnoses annually. Most patients are diagnosed at a late stage and typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, recurrence is common, requiring multiple subsequent lines of therapy with diminishing efficacy and tolerability. Patients who respond to initial platinum-based chemotherapy and relapse six months or later are classified as platinum sensitive, while those who relapse within six months are considered platinum resistant. Platinum-based chemotherapy remains the most effective treatment for early lines of ovarian cancer, but its benefits decrease with each subsequent line of therapy. There is no universally accepted standard of care for third-line or later patients, particularly after progression on PARP inhibitors.

Mirvetuximab soravtansine is a first-in-class Antibody-Drug Conjugate (ADC) targeting folate receptor alpha, consisting of an FRα-binding antibody, a cleavable linker, and the cytotoxic agent DM4, which inhibits tubulin to kill cancer cells. Approved under the brand name ELAHERE® in the U.S., it is indicated for adults with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatments. Patient selection is based on an FDA-approved test. The Marketing Authorization Application for ELAHERE in Europe has been accepted by the European Medicines Agency, with regulatory submissions under review in several other countries. The safety and efficacy of mirvetuximab soravtansine for platinum-sensitive ovarian cancer have not been established.

AbbVie is committed to transforming oncology care through a dynamic pipeline of investigational therapies across various cancer types. The company focuses on creating targeted medicines to impede cancer cell reproduction or facilitate their destruction, employing diverse treatment modalities including ADCs, Immuno-Oncology, bi-specific antibodies, and CAR-T platforms. AbbVie collaborates with innovative partners to expedite the delivery of breakthrough medicines and is evaluating over 20 investigational treatments in clinical trials globally, aiming to significantly impact patients' lives and improve access to cancer medicines.