Latest Clinical Update of FWD1802 Phase I Study Presented at ASCO 2025
From May 30 to June 2, 2025, local time in the United States, the world's largest academic conference in cancer research and treatment - the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting - will convene at the McCormick Place Convention Center in Chicago. The theme this year is “Driving Knowledge to Action: Building a Better Future.” ASCO brings together leading oncology experts from global to explore the latest breakthroughs in cancer treatment and innovations in clinical practice.
Forward Pharma announced the latest progress of its phase I clinical trial for FWD1802, a next-generation orally available, selective estrogen receptor degrader (oral SERD) for ER+/HER2- breast cancer endocrine therapy, at the ASCO 2025 Annual Meeting.
As of January 6, 2025, a total of 47 patients were enrolled in the FWD1802 phase I clinical trial. Based on the clinical data, FWD1802 monotherapy demonstrated good tolerability, excellent safety, and promising efficacy in breast cancer patients who had previously received multiple lines of endocrine therapy. Objective responses were observed in patients with both wild-type and mutant ESR1, with superior efficacy noted in mESR1 (ESR1-mutant) patients. The Recommended Phase 2 Dose (RP2D) will be determined once additional patient data are collected.
This research abstract has been published in the supplement of the Journal of Clinical Oncology (JCO), a leading academic journal in oncology.
Image source: ASCO Publications
The clinical updates of FWD1802 published by Forward Pharm at the ASCO 2025 Annual Meeting aligns closely with key directions for the future development of SERD drugs, demonstrating the promising development potential of FWD1802 as a next-generation backbone drug for endocrine therapy in breast cancer!
FWD1802 is anticipated to initiate the pivotal Phase III clinical trial. Forward Pharma is committed to strengthening comprehensive collaboration with global partners to accelerate clinical development and product commercialization, thereby bringing clinical benefits to breast cancer patients worldwide.
About ASCO
Founded in 1964, the American Society of Clinical Oncology (ASCO) is one of the world's leading academic organizations in oncology, with over 45,000 members from more than 150 countries. Its mission is to conquer cancer through research, education, and the promotion of high-quality patient care. Its annual meeting is the largest and most influential international oncology conference, serving as a premier global platform where leading scientists, clinicians, and pharmaceutical companies share cutting-edge research findings and clinical practices.
About Forward Pharmaceuticals
Forward Pharmaceuticals is an innovative biopharmaceutical company with independent R&D capabilities spanning the entire drug discovery process - from target validation, drug discovery, early-stage development, translational medical research, and preclinical studies to clinical development and regulatory registration. Headquartered in Nanshan, Shenzhen, the company has established international operations and R&D teams in Pudong, Shanghai, and Wuhan Optics Valley. Forward Pharma has built a drug discovery platform with core proprietary intellectual property and a distinctive drug R&D innovation system over its decade-long journey. Leveraging this platform, the company has developed a product pipeline matrix featuring over 10 innovative drugs, with indications spanning multiple solid tumors and autoimmune diseases.
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