Imbruvica (Ibrutinib; Bruton’s tyrosine kinase (BTK) inhibitor) – Johnson & Johnson/Abbvie

• Imbruvica is already approved in Europe for CLL as monotherapy or in combination with obinutuzumab in treatment naïve It is also approved in Europe as a monotherapy or in combination with bendamustine and Mabthera for the treatment of CLL in adults who had gone through at least one prior therapy
• European Commission (EC) has extended the approved indication in chronic lymphocytic leukemia (CLL) to include combination with Mabthera for previously untreated adult patients
• The decision is based on data from the Phase 3 E1912 study that showed previously untreated patients aged 70 years or younger treated with Imbruvica plus rituximab lived longer without disease progression than those treated with the established chemo-immunotherapy regimen fludarabine, cyclophosphamide and rituximab (FCR)
• N = 529 previously untreated patients with CLL aged 70 years or younger (median age, 58 years) who were randomly assigned to receive six cycles of ibrutinib plus rituximab (IR) (n=354), followed by ibrutinib until disease progression or unacceptable toxicity, or six cycles of FCR (n=175)
• Results:
  • At a median follow-up of 37 months, patients treated with IR lived longer without disease progression, with a PFS rate of 88%, compared to 75% for patients treated with FCR (hazard ratio [HR] 0.34; 95% confidence interval [CI], 0.22-0.52; p<0.0001)
  • The study also showed an OS advantage for patients treated with the IR regimen
  • This study results (PFS at 3 years: 89.4%; OS at 3 years: 98.8%, N=529)were published previously in “The New England Journal of Medicine”, and with extended 48-month follow-up showing stable hazard ratio for both PFS and OS, was presented at the ASH2019, the initial treatment benefit was maintained