Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a China-based pharmaceutical innovator, has published data from a Phase I clinical study for its novel anti-tumor drug, LX-039. This oral selective estrogen receptor modulator (SERD) was in the spotlight at the European Society for Medical Oncology (ESMO) Congress 2023, where its potential in treating advanced breast cancer was discussed.
Study Design and Patient Demographics
The study was structured to evaluate the safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics, as well as the preliminary anti-tumor activity of LX-039. It focused on postmenopausal patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who had not responded to endocrine therapy. Using a “3+3” protocol, the dosage was escalated from 50mg once daily to 1,200mg once daily, exploring the drug’s safety across a range of doses.
Results and Therapeutic Potential
Among the 44 patients enrolled, who had received multiple lines of anti-tumor endocrine therapy, four subjects achieved partial response. This resulted in an objective response rate of 10.8% and a clinical benefit rate of 40% at 24 weeks. LX-039 showed good tolerability and favorable PK/PD characteristics, indicating its potential as a treatment for ER+ and HER2- advanced breast cancer. The study’s findings have paved the way for a Phase II clinical trial, which is anticipated to further explore the drug’s efficacy and safety.-Fineline Info & Tech
