Zhejiang-based TYK Medicines Inc. (HKG: 2410) announced positive results from a pivotal Phase II study positioning TY-9591 against osimertinib as a first-line treatment for epidermal growth factor receptor (EGFR) mutated lung cancer with brain metastasis. The data demonstrated statistical significance and significant clinical benefits, marking a potential breakthrough in the treatment of this specific cancer indication.
Study Details and Results
The trial enrolled a total of 224 subjects, with the proportions of patients with exon 19 deletion and exon 21 L858R mutation being 53.1% and 46.9%, respectively. These figures align with the real-world distribution of gene mutation levels in patients. The primary endpoint of the study, the intracranial objective response rate (iORR), was successfully met.
Superiority of TY-9591
TY-9591, a tyrosine kinase inhibitor (TKI) targeting EGFR mutant lung cancer with brain metastasis, demonstrated statistically significant and clinically meaningful improvements compared to osimertinib. The drug showed significant statistical differences in both the entire study population and across various subgroups, including genotype, number of intracranial lesions, and ECOG score.
Market Implications
With these results, TY-9591 becomes the world’s first and only drug to show significant superiority over osimertinib in clinical trials for EGFR mutant lung cancer brain metastases. The company expects to file for market approval in China in the near term, which could potentially reshape the treatment landscape for this condition.-Fineline Info & Tech
Leave a Reply