Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted a clinical trial application for the combination of two pipeline candidates, ASKC202 tablets and ASK120067 tablets. The company is seeking to evaluate this combination therapy in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has progressed after previous treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and has been confirmed as having MET gene abnormalities or protein overexpression.
ASKC202: A c-MET Inhibitor
ASKC202 is a Class 1 innovative, potent, and highly selective oral small-molecule c-MET inhibitor with independent intellectual property rights. The clinical trial application for ASKC202 in advanced solid tumors with abnormal MET expression was previously approved by NMPA, with a Phase I study currently underway. Early data from this study have shown positive results for both efficacy and safety.
ASK120067: A Third-Generation EGFR-TKI
ASK120067 is a third-generation EGFR-TKI under development to treat patients with locally advanced or metastatic NSCLC following disease progression during or after initial EGFR-TKI treatment, confirmed as having an EGFR T790M mutation-positive disease. A marketing authorization application for this indication is under review by the NMPA. Additionally, a Phase III clinical trial for the drug’s use in the first-line NSCLC setting in patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations has completed enrollment and is ongoing.
Overcoming Resistance with Combined Inhibition
Abnormal activation of the MET pathway is believed to be related to resistance mechanisms of various targeted therapies, particularly those that bypass resistance to EGFR inhibitors. Preclinical pharmacodynamic studies of combined drugs have shown that the combination of EGFR-TKI with c-MET inhibition can produce good therapeutic results in overcoming EGFR-TKI resistance, offering a potential new treatment approach for patients with NSCLC.- Flcube.com
