relapsed FL after 2
based on a phase 2 trial
ZYDELIG 150 mg BID
until progression or
- 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.
|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.
|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%|
|Baseline cytopenias, grade ≥1†|
Neutropenia Anemia Thrombocytopenia
|Prior regimens, median (range)||4 (2-12)|
|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.