TYK MEDICINES-B(02410): The key Phase II clinical trial data comparing TY-9591 to osimertinib as first-line treatment for EGFR mutation lung cancer with brain metastasis showed that the study met expectations, demonstrating statistical significance and significant clinical benefits.

TYK MEDICINES-B(02410) announced that their independently developed TY-9591 (trade name: Kadasa) has shown significant clinical benefits in a phase II clinical trial compared to osimertinib (trade name: Tagrisso) as a first-line treatment for EGFR-mutated lung cancer with brain metastasis. The study data presented by researchers indicate statistically significant and clinically significant improvements. The primary endpoint of intracranial objective response rate (iORR) was achieved, with TY-9591 showing statistically and clinically significant improvement compared to osimertinib, with significant statistical differences observed in the overall population and different subgroups (including genetic subtypes, number of intracranial lesions, ECOG score, etc). The company plans to submit a New Drug Application (NDA) for market approval to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in the near future.