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

On June 6, 2024, AbbVie announced encouraging results from the Phase 2 PICCOLO trial, which evaluated mirvetuximab soravtansine (ELAHERE) as a monotherapy in patients with heavily pre-treated, folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The trial achieved its primary goal with an objective response rate (ORR) of 51.9%, according to the 95% confidence interval (40.4 – 63.3%).

The secondary endpoint, which measured the median duration of response (DOR), indicated a period of 8.25 months. The safety profile of mirvetuximab soravtansine was consistent with previous findings, and no new safety issues were detected. Detailed data from the PICCOLO trial are expected to be presented at an upcoming medical conference.

Dr. Angeles Alvarez Secord from the Duke Cancer Institute emphasized the importance of these findings, stating, "Patients with platinum-sensitive disease face significant unmet needs as each subsequent line of therapy offers reduced efficacy and tolerability. This underscores the necessity for alternative treatments." She added that the PICCOLO data further highlight the potential of mirvetuximab soravtansine for these patients.

About the PICCOLO Trial

The PICCOLO trial is a single-arm Phase 2 study designed to assess the efficacy and safety of mirvetuximab soravtansine in patients with high FR-alpha platinum-sensitive ovarian cancer who have undergone at least two prior lines of platinum-based therapy or have a documented platinum allergy. The study aimed to statistically rule out an ORR of 28% or lower, which is a response rate observed with non-platinum, single-agent chemotherapy in platinum-sensitive diseases.

The trial specifically targets patients with multiple prior lines of platinum-based therapy or those ineligible for such treatments, who currently lack an established benchmark standard of care, especially after disease progression on a PARP inhibitor.

Mirvetuximab soravtansine is also being evaluated in the Phase 3 GLORIOSA trial, in combination with bevacizumab, compared to bevacizumab alone, for maintenance therapy following second-line platinum-doublet therapy in PSOC patients.

Ovarian Cancer Overview

Ovarian cancer is the leading cause of death from gynecological cancers in the U.S., with approximately 20,000 new diagnoses annually. Most patients present with advanced-stage disease and typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of these patients experience disease recurrence, necessitating multiple further lines of treatment with decreasing efficacy and tolerability. Patients who respond to initial platinum-based chemotherapy and relapse after six months are classified as platinum-sensitive, while those who relapse within six months are considered platinum-resistant.

Although platinum-based chemotherapy remains the most active treatment for earlier lines of ovarian cancer, each subsequent line generally shows reduced benefits. For third-line or later patients whose cancers have progressed on PARP inhibitors, there is no widely accepted standard of care with a clear efficacy benchmark based on prospective trials.

About Mirvetuximab Soravtansine

Mirvetuximab soravtansine, marketed as ELAHERE in the U.S., is a first-in-class antibody-drug conjugate (ADC) that combines a folate receptor alpha-binding antibody with a cleavable linker and the potent tubulin inhibitor DM4. It is designed to target and kill cancer cells. ELAHERE has received regulatory approval in the U.S. for adults with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatments. Regulatory submissions are also under review in multiple other countries.

AbbVie’s Commitment to Oncology

AbbVie remains dedicated to transforming cancer care standards, advancing a robust pipeline of investigational therapies across various cancer types, including both blood cancers and solid tumors. The company focuses on creating targeted medicines that aim to either impede cancer cell reproduction or facilitate their elimination using various treatment modalities, including ADCs, Immuno-Oncology, bi-specific antibodies, and CAR-T platforms.

AbbVie's oncology portfolio includes both approved and investigational treatments for a wide range of cancers. The company is actively evaluating over 20 investigational medicines in clinical trials for some of the most prevalent and debilitating cancers. As part of its commitment, AbbVie aims to ensure patient access to its cancer medications and continues to explore solutions that could significantly impact patients' lives.

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