Bio-Thera Solutions Inc. has initiated dosing in a pivotal phase 3 clinical trial for BAT8006, an antibody-drug conjugate targeting folate receptor α (FRα) for the treatment of platinum-resistant ovarian cancer. The Chinese biopharmaceutical company announced on June 25, 2025, that the first patient has been dosed in the randomized, open-label, parallel-group study designed to evaluate BAT8006's efficacy compared to investigator's choice of single-agent chemotherapy.
Promising Early Clinical Results
Early clinical data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated encouraging results for BAT8006 in platinum-resistant ovarian cancer. Among 133 enrolled patients in the dose-escalation and expansion study, regardless of FRα expression levels or prior lines of therapy, BAT8006 achieved a median progression-free survival of 7.63 months. The therapy demonstrated an objective response rate of 40.7% and a disease control rate of 80.5%.
Notably, the safety profile appeared favorable, with no cases of interstitial lung disease or ocular toxicity observed during the study. These findings suggest BAT8006 exhibits significant clinical efficacy while maintaining a manageable safety profile.
Addressing Unmet Medical Need
Platinum-resistant ovarian cancer represents a significant clinical challenge characterized by poor patient prognosis and limited treatment options. Currently, only one FRα-targeting antibody-drug conjugate is approved globally, with its indication restricted to patients with FRα expression ≥75%, representing only 25%-30% of the platinum-resistant population. This approved therapy demonstrates limited median progression-free survival and is associated with ocular toxicity.
BAT8006 has the potential to demonstrate clinically meaningful efficacy across the full spectrum of platinum-resistant ovarian cancer patients, regardless of FRα expression levels. This broader applicability could address a significant unmet medical need for patients who do not qualify for existing FRα-targeted therapies.
Phase 3 Trial Design
The phase 3 clinical trial (Clinical Trial Registration Number: CTR20251345) is designed to assess BAT8006's efficacy versus investigator's choice of single-agent chemotherapy in patients with platinum-resistant high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. As one of the first FRα ADCs in China entering a pivotal phase 3 clinical trial, BAT8006 represents a potentially significant advancement in the treatment landscape for this challenging indication.
Company Background
Bio-Thera Solutions, Ltd., based in Guangzhou, China, is a commercial-stage biopharmaceutical company focused on developing innovative therapeutics and biosimilars. The company has five approved products, including QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® in the US, and BAT1806/TOFIDENCE™ (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and EU. The company maintains more than 20 candidates in clinical trials, with a focus on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates.
