FWD1802 Combo Study Achieved First Patient In
On June 24, 2025, Forward Pharma announced the successful enrollment of the first patient in the clinical study evaluating FWD1802 in combination with either palbociclib, ribociclib, abemaciclib, or everolimus for the treatment of ER+/HER2- unresectable locally advanced or metastatic breast cancer. This combination study for HR+/HER2- locally advanced or metastatic breast cancer demonstrates the significant development potential of FWD1802 as a next-generation endocrine therapy backbone drug.
The leading principal investigator for this study is Professor Zhang Jian, Chief Physician of the Department of Medical Oncology at Fudan University Shanghai Cancer Center, doctoral supervisor, and Executive Director of the Phase I Clinical Trial Unit at Fudan University Shanghai Cancer Center.
FWD1802 received Investigational New Drug (IND) approval from the FDA (U.S.) on March 23, 2023, and from the NMPA (China) on July 5, 2023, authorizing the initiation of the monotherapy clinical trial. Subsequently, on May 16, 2025, another IND was approved from the NMPA to conduct a combination therapy clinical trial.
FWD1802 is a third-generation oral selective estrogen receptor degrader (oral SERD) for breast cancer endocrine therapy. FWD1802 acts as a competitive antagonist of the estrogen receptor (ER), inducing conformational changes in the ER protein and promoting its degradation, ad well as ER antagonism, thereby as a complete ER antabonist, demonstrating superior in vitro and in vivo efficacy compared to other oral SERDs under development. It remains effective against ESR1 mutations emerging after standard endocrine therapy. This positions FWD1802 not only as a treatment option for ESR1-mutated breast cancer resistant to conventional endocrine therapy but also as a potential replacement for existing endocrine regimens, establishing it as a new standard endocrine treatment. Additionally, FWD1802 demonstrates favorable in vivo bioavailability, enabling convenient oral administration for patients in clinical settings.
With the achievement of successful FPI in the combination study, FWD1802 has advanced to the next level of clinical development.
Forward Pharma anticipates that through this clinical study, FWD1802 will benefit patients with HR+/HER2- locally advanced or metastatic breast cancer whose clinical needs remain unmet. This represents not only clinical research progress but also a significant stride by China's innovative pharmaceutical industry and enterprises in contributing to global breast cancer treatment regimens.
About Forward Pharmaceuticals
Forward Pharmaceuticals is an innovative biopharmaceutical company with an independent R&D pipeline spanning target validation, drug discovery, early-stage development, translational medicine research, preclinical studies, clinical development, and regulatory affairs. The company has established international R&D and operational teams in Nanshan District, Shenzhen; Pudong, Shanghai; and Optics Valley, Wuhan. Forward Pharmaceuticals has established a proprietary drug discovery platform with core intellectual property rights and a distinctive drug R&D innovation system since its inception. Building upon this platform, the company has developed a product pipeline matrix featuring over 10 innovative drugs, with indications spanning multiple solid tumors and autoimmune diseases.
Related Reading: