By Fineline Cube China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for LY01005 in breast cancer treatment has successfully met pre-set endpoints. The study demonstrated that LY01005 effectively controls serum estradiol to postmenenopausal levels, with clinical efficacy comparable to a control drug, achieving a non-inferiority standard.
Study Details
The randomized, open, positive-controlled study involved intramuscular administration of LY01005 at a dose of 3.6 mg every 28 days. Results showed that the drug’s safety profile is similar to the control, with no adverse reactions at the injection site. This enhances patient compliance and overall safety and tolerance.
Drug Profile
LY01005 is a microsphere preparation of gonadotropin-releasing hormone agonist goserelin, designed for monthly intramuscular injection. It is intended to treat prostate cancer, breast cancer, and endometriosis. AstraZeneca’s subcutaneous implant form of goserelin acetate is currently available globally for prostate cancer treatment. Luye filed for market approval of LY01005 for prostate cancer in December 2021.-Fineline Info & Tech