Full Efficacy & Safety Summary Table
Indication | Patients with treatment naïve and previously treated mNSCLC with METex14 Skipping Alterations |
Registrational Trial | Accelerated Approval. Phase 2 single arm VISION trial (n=152) (NCT02864992) |
Regimen | Monotherapy. Once daily oral |
Efficacy Outcomes | ORR: 43% DOR: 10.8 mo |
Safety Outcomes | Total Grade 3/4 ARs: 29% Discontinuation Rate: 20% Dose Reduction Frequency: 30% Key Grade 3/4 at ≥5%: Edema (9%) & Pleural Effusion (5%) |