Eisai Presents New Findings for Antibody Drug Conjugate Farletuzumab Ecteribulin at 2022 ASCO Annual Meeting – QNT Press Release


Poster Discussion Features Investigational Safety and Efficacy Data from the Platinum-Resistant Ovarian Cancer Cohort Expansion of a Phase 1 Study Evaluating Farletuzumab Ecteribulin (MORAb-202) in Solid Tumors (Abstract: #5513)

Poster Presentation Features Analyses Based on PK/PD Modeling/Simulations for Dose Optimization of Farletuzumab Ecteribulin Including Findings for Body Surface Area-Based Dosing (Abstract: #3090)

NUTLEY, NJ, June 5, 2022 /PRNewswire/ — Eisai announced today new investigational data from the platinum-resistant ovarian cancer (PROC) cohort expansion of a Phase 1 study (Study 101) evaluating the antibody drug conjugate (ADC) co-developed by Eisai and Bristol Myers Squibb, farletuzumab ecteribulin (MORAb-202). The safety and efficacy findings are being featured in a poster discussion at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO22), a hybrid meeting in Chicago from June 3 to 7 (NCT03386942; Abstract: #5513). Farletuzumab ecteribulin is composed of Eisai’s in-house developed farletuzumab, a humanized IgG1 monoclonal antibody that binds to the folate receptor alpha (FRα), and Eisai’s anticancer agent eribulin, a microtubule dynamics inhibitor, using an enzymatically cleavable linker.

“We are encouraged by the clinical safety and efficacy results, as measured by the preliminary antitumor activity observed in patients with platinum-resistant ovarian cancer being treated with each dose of farletuzumab ecteribulin, and with varying levels of folate receptor alpha expression,” said Shin NishioMD, PhD, Principal Investigator and Associate Professor, Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan. “Based on the data from pre-clinical studies, farletuzumab ecteribulin has the clinical potential to elicit a bystander effect through an enzymatically cleavable linker that releases a toxic payload from the antibody, therefore acting not only on the folate receptor alpha-positive cancer cells , but also the folate receptor alpha-negative cancer cells surrounding the folate receptor alpha-positive cancer cells. As the field of targeted therapy continues to evolve, antibody drug conjugates are anticipated to become a key modality in the treatment of recurrent, platinum-resistant disease.”

Ovarian cancer is typically diagnosed at advanced stages of disease, with most patients facing a poor prognosis because of high rates of recurrence and subsequent development of chemoresistance.1 High-grade serous ovarian cancer (HGSOC) is the most common type of ovarian cancer and tends to spread before it can be detected.2-3 Ovarian tumors express a great number of tumor-antigens that can be used to guide targeted medicines, including the FRα biomarker, which is often overexpressed in epithelial ovarian carcinomas.4-5 FRα is considered as a marker of tumor aggressiveness and is associated with poorer response rates to treatment.6

“As part of our human health care mission, Eisai remains dedicated to exploring novel treatment approaches with the goal of addressing unmet needs of people living with cancer,” said Dr. Takashi OwaPresident, Oncology Business Group at Eisai. “The data for our first antibody drug conjugate, which was discovered in-house with Eisai technology, demonstrate the company’s commitment to working to advance precision medicine to improve care for women in need of additional treatment options . We look forward to sharing further results assessing farletuzumab ecteribulin as a potential treatment for patients with platinum-resistant ovarian cancer.”

Trial Design
The primary objective of this Phase 1 study conducted in Japan (Study 101) was to determine the safety and tolerability of farletuzumab ecteribulin. Selected secondary objectives included determining the recommended dose of farletuzumab ecteribulin for future studies, pharmacokinetic characterization and an efficacy assessment, including objective response rate (ORR) and disease control rate (DCR ). Doses of farletuzumab ecteribulin from 0.3 to 1.2 mg/kg, administered by intravenous (IV) fusion every 3 weeks (Q3W), were then evaluated. The dose-escalation part of Study 101 suggested that treatment with farletuzumab ecteribulin led to antitumor activity in patients with FRα-positive solid tumors, including patients with ovarian cancer. Based on the efficacy and safety results from the dose-escalation part of this study, farletuzumab ecteribulin 0.9 mg/kg (Cohort 1) and 1.2 mg/kg (Cohort 2 ) administered by IV fusion Q3W were selected for the expansion part of this study in patients with platinum-resistant ovarian cancer. Patients were required to hav e FRα-positive tumors, assessed by immunohistochemistry assay, with positive expression defined as > 5% of cells stained on a slide at 1+, 2+ or 3+ intensity …

Full story available on Benzinga.com


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