On June 25, 2025 Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, reported that dosing has begun in a phase 3 clinical study for BAT8006, an antibody drug conjugate targeting folate receptor α for the treatment of platinum-resistant ovarian cancer (Press release, BioThera Solutions, JUN 25, 2025, View Source;for-the-treatment-of-platinum-resistant-ovarian-cancer-302490679.html [SID1234654121]). The phase 3, randomized, open-label, parallel-group clinical trial (Clinical Trial Registration Number: CTR20251345) of BAT8006 is designed to assess the efficacy of BAT8006 versus investigator’s choice of single-agent chemotherapy in patients with platinum-resistant high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
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At the Rapid Oral Abstract Session of the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, early clinical data of BAT8006 demonstrated promising results in platinum-resistant ovarian cancer. Among 133 enrolled patients (regardless of FRα expression levels or prior lines of therapy) in the dose-escalation and expansion study, the therapy achieved a median progression-free survival (PFS) of 7.63 months, with an objective response rate (ORR) of 40.7% and disease control rate (DCR) of 80.5%. Importantly, no cases of interstitial lung disease or ocular toxicity were observed. These findings indicate that BAT8006 exhibits significant clinical efficacy and a favorable safety profile, highlighting its strong clinical potential for platinum-resistant ovarian cancer.
Platinum-resistant ovarian cancer remains a significant clinical challenge with poor patient prognosis and limited treatment options. Currently, only one FRα-targeting antibody-drug conjugate (ADC) is approved globally, and its indication is restricted to patients with FRα expression ≥75% (only 25%-30% of the platinum-resistant population). This approved therapy demonstrates limited median progression-free survival (mPFS) and is associated with ocular toxicity.
As one of the first FRα ADCs in China entering a pivotal phase 3 clinical trial, BAT8006 has the potential to demonstrate clinically meaningful efficacy across the full spectrum of platinum-resistant ovarian cancer patients (regardless of FRα expression levels). These promising data suggest BAT8006 may offer a novel therapeutic option for this difficult-to-treat population.