Shots:

• The approval of Augtyro (160mg, oral, QD for 14 days then BID until progression) was based on P-I/II (TRIDENT-1) study of its safety, tolerability, PK & anti-tumor activity in adults & pediatrics (≥12yrs.) with NTRK+, locally advanced/metastatic solid tumors. Full approval depends upon confirmatory studies
• In TKI-naïve patients (n=40) at a median follow-up of 17.8mos., 58% had cORR (PR in 43% & CR in 15%); 83% remained in response at 1yr. with mDoR not attained & intercranial responses in 2/2 of them
• In TKI-pretreated patients (n=48) at a median follow-up of 20.1mos., 50% had cORR (all had PR); 42% remained in response at 1yr. with mDoR of 9.9mos. & intercranial responses in 3/3 of them. Safety & efficacy in <12yrs. old patients are not evaluated

Ref: BMS | Image: BMS

Related News:- Zai Lab’s Augtyro Receives the NMPA’s Approval to Treat Non-Small-Cell Lung Cancer (NSCLC)

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