China-based Qilu Pharmaceutical has announced that its Category 1 chemical drug, iruplinalkib, an ALK inhibitor, has obtained marketing approval from the National Medical Products Administration (NMPA). This approval allows the use of iruplinalkib to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbor anaplastic lymphoma kinase (ALK) mutations or are intolerant to crizotinib.
Phase II INTELLECT Study Results
The Phase II INTELLECT study evaluated the efficacy of iruplinalkib in ALK-positive NSCLC patients resistant to crizotinib. The study demonstrated an objective response rate (ORR) of up to 69.9%, a disease control rate (DCR) of 96.6%, and a median progression-free survival (mPFS) of 19.8 months in this patient population. Notably, among patients with baseline brain metastasis, the intracranial remission rate for those treated with iruplinalkib reached 64%.
Phase III Clinical Study and ROS1 Positive NSCLC Patients
Furthermore, a Phase III clinical study comparing iruplinalkib to crizotinib for the first-line treatment of ALK-positive NSCLC has completed a mid-term analysis, showing significant advantages for iruplinalkib. In additional clinical studies focusing on ROS1-positive NSCLC patients previously untreated with crizotinib, iruplinalkib achieved an ORR of 74%, a DCR of 96%, and a median duration of remission at 14.51 months. The drug also demonstrated efficacy in patients with resistance to crizotinib, with 2 out of 9 patients achieving partial response and a 6-month response rate of 100%.-Fineline Info & Tech
