Disease Burden and Unmet Need

Even with targeted treatment, long-term survival remains a challenge in ALK+ NSCLC.4

ALK+ NSCLC is a distinct, targetable disease—often affecting younger, healthier patients who are frequently diagnosed in the later stages of the disease.5-7

NSCLC accounts for 80% to 85% of all lung cancer cases.8

  • 5% to 7% of cases are ALK+—a targetable driver mutation3,5,7,9
  • ~10,000 new cases are diagnosed annually in the U.S.—reflecting an incidence of 2.89,10

Disease Overview

Younger patients—often diagnosed in the later stages of the disease6,11

Median age: ~52 (versus ~70 years for other types of NSCLC)6,11

  • Significantly younger than the broader NSCLC population
  • Often face a longer treatment journey

Non-smokers or light smokers6

~70% of patients with ALK+ NSCLC have never smoked12

Advanced disease at diagnosis11

~70% of patients are diagnosed with stage IIIb/IV11

  • Late diagnosis limits opportunities for curative treatment11

ALK is an oncogenic driver mutation for a distinct subset of NSCLC11,13

Even with targeted treatment, long-term survival remains a challenge in ALK+ NSCLC.4

While incremental improvements have been achieved, survival is still low.4

  • TKI inhibitors have offered promise in extending overall survival in ALK+ NSCLC4
  • ALK+ NSCLC patients are currently treated with 1st, 2nd, and 3rd generation ALK inhibitors, yet 5-year survival is still only ~60%4

Unmet needs remain: Achieving consistent, long-term survival continues to be a significant area for improvement in the treatment of ALK+ NSCLC.4,14

CNS metastases are common, early, and progressive in ALK+ NSCLC.15,16

CNS metastases are associated with worse patient outcomes17

  • ~70% of patients may develop CNS metastases18
  • 8.5 months from diagnosis is the median onset of CNS metastases15,16

ALK, anaplastic lymphoma kinase; NSCLC, non-small cell lung cancer; TKI, tyrosine kinase inhibitor; CNS, central nervous system; FDA, Food and Drug Administration.

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

Established Safety

Established safety profile over a median follow up of 74 months.1,3