Bio-Thera Solutions has initiated dosing in the randomised Phase III trial of the antibody-drug conjugate (ADC), BAT8006, aimed at treating platinum-resistant ovarian cancer (PROC).
This open-label, parallel-group study will compare the efficacy of BAT8006 against a standard single-agent chemotherapy of the investigator’s choice.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIt targets those with platinum-resistant, high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Early clinical data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting showcased the ADC’s promising outcomes in treating PROC.
Regardless of the levels of folate receptor α (FRα) expression or previous therapy lines, in the 133 subjects who enrolled, the ADC achieved a median progression-free survival (PFS) of 7.63 months, with a disease control rate (DCR) of 80.5%, and an objective response rate (ORR) of 40.7%.
There were no cases of interstitial lung disease or ocular toxicity reported.
According to the company, PROC presents a significant challenge in clinical settings, often resulting in poor patient outcomes and limited treatment alternatives.
BAT8006 claims to be one of the first FRα ADCs in China to enter a Phase III trial, and could potentially offer a new treatment option for a broader range of individuals with PROC, regardless of FRα expression levels.
Bio-Thera has five approved products in progress, including Qletli and Betagrin in China, Starjemza in the US, and BAT1806/Tofidencetm and Avzivi in the US and European Union (EU), known as Pobevcy in China.
The company also has more than 20 candidates in clinical trials, focusing on immuno-oncology and targeted therapies, such as ADCs.
Last year, Bio-Thera progressed its monoclonal antibody BAT6026 into a Phase Ia/IIb trial for the treatment of atopic dermatitis.
In 2023, the company shared encouraging Phase I clinical data assessing BAT8006 for the treatment of advanced solid tumours.
ADC content on Pharmaceutical Technology (Or Clinical Trials Arena) is supported by Syngene. Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.
