Shanghai-based TYK Medicines has announced that it has received the green light from the Center for Drug Evaluation (CDE) to proceed with a pivotal Phase II clinical study for its drug candidate TY-9591, a novel therapy targeting lung cancer with brain metastases. This trial is strategically designed to support a conditional market authorization, indicating a significant step forward in the treatment of non-small cell lung cancer (NSCLC) with brain metastases.
High Incidence and Mortality of NSCLC in China and the Challenge of Brain Metastases
Non-small cell lung cancer (NSCLC) is the malignancy with the highest incidence and mortality rates in China, with approximately 20%-40% of patients developing brain metastases during the disease’s progression. The incidence is particularly high in patients with the driver gene of lung cancer, and brain metastases can occur in up to 44-63% of advanced lung adenocarcinoma with EGFR mutation. Existing standard clinical therapies offer limited benefits, with objective intracranial remission rates of about 23%-45% and median survival of approximately 3-6 months with radiotherapy.
TY-9591: An Innovative EGFR Inhibitor for Lung Cancer with Brain Metastases
TY-9591 is an innovative, highly selective, and safe novel Epidermal Growth Factor Receptor (EGFR) inhibitor with a full intellectual patent of Category 1 chemical drug granted by CDE. Since the approval of its Investigational New Drug (IND) application in October 2019, a Phase I study exploring safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) has been conducted, along with a Phase II study evaluating efficacy for lung cancer with brain metastases. Additionally, a study comparing the pharmacokinetics of TY-9591 with osimertinib and the effect of food on the pharmacokinetics of TY-9591 has been initiated. TY-9591 has demonstrated excellent efficacy and a favorable safety profile in the treatment of non-small cell lung cancer with brain metastases, positioning it as a promising new treatment option.-Fineline Info & Tech
