Chia Tai Tianqing’s next-generation ALK inhibitor, envonalkib, has received approval from the National Medical Products Administration (NMPA) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for anaplastic lymphoma kinase (ALK) and have not been previously treated with ALK inhibitors.
A multi-center, randomized, controlled Phase III study compared the Category 1 product envonalkib with the first-generation ALK inhibitor crizotinib in first-line ALK-positive NSCLC. As of August 31, 2022, the median progression-free survival (mPFS) for envonalkib was 24.87 months compared to 11.6 months for crizotinib. In patients with assessable brain metastases at baseline, the objective response rates (ORR) for envonalkib and crizotinib were 78.95% and 23.81%, respectively, with durations of response (DOR) at 25.82 months and 7.39 months, respectively. The results were published in the journal Signal Transduction and Targeted Therapy in August last year.- Flcube.com
