China-based firm InxMed (Nanjing) Co., Ltd has updated two clinical studies for its first-in-class small-molecule FAK inhibitor ifebemtinib (IN10018) at the European Society for Medical Oncology (ESMO) Congress 2023. The studies evaluated the drug’s efficacy and safety in treating platinum-resistant recurrent ovarian cancer and advanced triple negative breast cancer.
Phase Ib Clinical Study for Ovarian Cancer
The Phase Ib clinical study assessed IN10018 in combination with pegylated liposomal doxorubicin (PLD) for platinum-resistant recurrent ovarian cancer. With 61 patients enrolled and 54 eligible for efficacy evaluation, the study reported 1 complete response (CR) and 24 partial responses (PR), achieving an objective response rate (ORR) of 46.3%. A total of 20 cases of stable disease (SD) were observed, resulting in a disease control rate (DCR) of 83.3%. Median progression-free survival (mPFS) was approximately 7.56 months, and median overall survival (mOS) was about 20.9 months. The IN10018 regimen demonstrated good safety and tolerability, equivalent to that of the respective single drugs.
Phase Ib/II Study for Triple Negative Breast Cancer
The Phase Ib/II study evaluated IN10018 combined with PLD plus toripalimab in advanced triple negative breast cancer. The study enrolled 12 patients treated with IN10018 combined with PLD, and 14 subjects treated with IN10018 combined with PLD plus toripalimab. The three-drug combination group showed significant synergistic anti-tumor effects and survival benefits, with mPFS at 7.43 months and mOS not yet reached, with a lower limit of 9.26 months for 95% CI. Both combinations demonstrated good safety and tolerability.
Global Rights and Regulatory Milestones
InxMed owns global exclusive development and commercial operation rights to IN10018, which has been awarded fast-track status in the United States and breakthrough therapy designation (BTD) in China. A market filing for the drug is expected next year.-Fineline Info & Tech
