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Safety Profile

In clinical trials of Ensacove™, safety was evaluated over a median follow up of 74 months.1

Established Safety Profile Over mFU of 74 Months1

Most common adverse reactions in eXALT3.1

Discontinuation, dose reduction, and serious adverse events.1

  • Permanent discontinuation of ENSACOVE due to an adverse reaction occurred in 12% of patients1
  • Adverse reactions which resulted in permanent discontinuation of ENSACOVE (≥1%) included increased ALT (2.1%), increased AST (2.1%), pneumonitis/ILD (2.1%), increased blood bilirubin (1.4%), and increased conjugated bilirubin (1.4%)1

mFU, median follow up; NCCN, National Comprehensive Cancer Network; 1L, first line; ALK, anaplastic lymphoma kinase; NSCLC, non-small cell lung cancer; SAEs, serious adverse events; AEs, adverse events; ALT, alanine transaminase; AST, aspartate aminotransferase; ILD, interstitial lung disease; QD, once daily.

Efficacy Data

Ensacove™ (ensartinib) is a second generation ALK TKI approved by the FDA for ALK+ NSCLC in patients who have not previously received an ALK-inhibitor.1

View eXalt3 Results