Topline  Presentation Points

BR is active as 1L therapy but has inferior PFS to FCR 

Update on BTKi’s and Venetoclax combinations 

  • [Recap of] RESONATE™-2 (PCYC-1115) 
    • Long-term PFS Benefit With Ibrutinib  
      • Depth of Response Improved Over Time With Continuous Ibrutinib Treatment 
  • Ibrutinib & Rituximab Improves Progression Free and Overall Survival Relative to FCR in Younger Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) 
  • Acalabrutinib: Second-Generation BTK Inhibitor 
    • ELEVATE-TN  
    • Investigator-assessed PFS  
  • VENETOCLAX-OBINUTUZUMAB FOR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA: 4-YEAR FOLLOW-UP ANALYSIS OF THE RANDOMIZED CLL14 STUDY  
  • Frontline BTKi vs. Ven + Obin:  Factors to Consider
    • BTKi  
      • Convenience (no infusions, TLS monitoring) 
      • Long term efficacy data 
      • Phase 3 data compared to FCR and BR 
      • More data for efficacy of ven at time of ibrutinib progression 
    • Ven+Obin 
      • Potential for 1-year time-limited therapy 
      • No known cardiac or bleeding risks 
      • Less concern for long term adherence 
      • Potential for cost-saving if 1-year of therapy is durable 
  • Frontline Ibrutinib + Venetoclax rapidly induces deep responses 
    • CAPTIVATE A Phase 2 Study of Ibrutinib + Venetoclax in 1L CLL 

Where are we heading in 1L CLL? 

  • Ongoing phase 3 trials: 
    • CLL13/GAIA: FCR/BR vs. VR, vs. VO, vs. IVO (n=920) 
    • UK NCRI FLAIR: FCR vs. I vs. IV (vs. IR) (n=1,522) 
    • Alliance A041702:  IO vs. IVO (older pts, n=454) 
    • ECOG EA9161:  IO vs. IVO (younger pts, n=720) 
    • ACE-CL-311:  FCR/BR vs AV vs AVO (n=780) 
    • CLL17:  I vs. IV vs. VO (n=882) 
    • CLL GLOW:  IV vs. Chl/O (n=200)