FL
Approved in
relapsed FL after 2
systemic therapies

ZYDELIG®
Trial Design

Accelerated approval
based on a phase 2 trial

Clinical Study Design: Phase 2, Single-Arm, Open-Label1

FL n=72

ZYDELIG 150 mg BID

Therapy maintained
until progression or
unacceptable toxicity

Clinical endpoints
  • Primary: Overall response rate, as assessed by an independent review committee1*
  • Secondary: Duration of response1

*Overall response rate was defined as the proportion of subjects who achieved a CR or PR.

CR=complete response; FL=follicular B-cell non-Hodgkin lymphoma; PR=partial response.

Key Eligibility Criteria1,2
  Double-refractory FL Failed to respond or relapsed within 6 months following therapy with rituximab and an alkylating agent  
  Prior therapies ≥2 prior systemic treatments  
  Karnofsky performance status ≥60 (Patient requires occasional assistance but is able to care for most of his/her personal needs)  
  ECOG performance status 0 to 2  
  FLIPI score All scores eligible  
  Baseline cytopenias ANC ≥1 x 109/L and platelet count ≥50 x 109/L  

ANC=absolute neutrophil count; ECOG=Eastern Cooperative Oncology Group; FLIPI=Follicular Lymphoma International Prognostic Index.

Patient Baseline Characteristics1,2
    FL (n=72)  
  Median age (range) 62 (33-84) years  
  Median time since diagnosis 4.7 years  
  High FLIPI score (>3) 54%  
  Ann Arbor stage III/IV 82%  
  Bulky disease* 22%  
  Baseline cytopenias, grade ≥1  
  Baseline cytopenias,
grade ≥1
Neutropenia Anemia Thrombocytopenia
24%42%33%  
  Prior regimens, median (range) 4 (2-12)  
  Most common
prior regimens

BR

50%

R-CHOP

49%

R-CVP

28%

 
  Refractory to ≥2 regimens 79%  
  Refractory to most recent regimen 90%  

*Bulky disease was defined as the presence of at least one lymph node with at least one dimension of ≥7 cm.1

†Cytopenias were defined as blood cell counts below the lower limit of normal. Anemia was defined as a disorder characterized by a reduction in the amount of hemoglobin in 100 mL of blood. Neutropenia was defined as a finding based on laboratory tests that indicate a decrease in the number of neutrophils in the blood specimen. Thrombocytopenia was defined as a finding based on laboratory test results that indicate a decrease in the number of platelets in the blood specimen.3

Includes patients of all histologies enrolled in the pivotal study (N=125), not just patients with FL.

BR=bendamustine, rituximab; R-CHOP=rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone; R-CVP=rituximab, cyclophosphamide, vincristine sulfate, prednisone.