Qilu Pharmaceutical, a leading pharmaceutical company based in China, has presented updated results from the Phase II INTELLECT study for its Category 1 drug iruplinalkib at the World Conference on Lung Cancer (WCLC). The study focuses on patients with cizotinib-resistant anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC).
As of December 29, 2023, the study enrolled a total of 146 subjects with a median follow-up time of 42.41 months. The median overall survival (OS) was recorded at 41.79 months. The objective response rate (ORR) and disease control rate (DCR), as evaluated by researchers, were 63.7% and 94.5%, respectively. The median duration of response (DoR) and progression-free survival (PFS) were 14.06 months and 14.55 months, respectively. In terms of safety, 93.8% of the participants (137 cases) experienced treatment-related adverse events (TRAEs), with 30.8% (45 cases) being grade 3 or 4. The most frequently reported TRAEs included elevated aspartate aminotransferase (45.2%), hypercholesterolemia (37.7%), and elevated alanine aminotransferase (37.0%), with no new safety concerns identified.
Iruplinalkib, an ALK inhibitor, received initial approval in China in June 2023 for the treatment of ALK-positive locally advanced or metastatic NSCLC patients who have progressed on or are intolerant to crizotinib. It was further approved in January of this year as a first-line treatment for ALK-positive NSCLC, marking a significant expansion in its therapeutic application. – Flcube.com
