Aosaikang Pharma begins phase 3 dosing for lung cancer treatment ASKC202

Beijing Aosaikang Pharmaceutical's wholly-owned subsidiary, Jiangsu Aosaikang Pharmaceutical, has announced the completion of first patient dosing in the registrational phase 3 clinical study for its Class 1 innovative drug, ASKC202. This study evaluates ASKC202 in combination with lianertinib for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification/overexpression, which has progressed after EGFR-TKI treatment. The study is a randomized, controlled, open-label, multi-center trial, planning to enroll 286 subjects.

The primary endpoint of the study is progression-free survival (PFS) as assessed by an independent review committee (IRC), with key secondary endpoints including overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety. ASKC202 is an oral cMET inhibitor developed for patients who have progressed after EGFR TKI treatment due to MET amplification/overexpression.

Previous phase 1/2 studies have demonstrated ASKC202's promising efficacy and good tolerability. In a phase 1 dose-escalation study, ASKC202 monotherapy showed an ORR of 62.5% and DCR of 75.0% in patients with MET amplification or missense mutations. The company anticipates ASKC202 in combination with lianertinib will provide an effective treatment option, enhancing its anti-tumor product pipeline.