relapsed SLL 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; PR=partial response; SLL=small lymphocytic lymphoma.
|Double-refractory SLL||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|
|Baseline cytopenias||ANC ≥1 x 109/L and platelet count ≥50 x 109/L|
ANC=absolute neutrophil count; ECOG=Eastern Cooperative Oncology Group.
|Median age (range)||65 (50-87) years|
|Median time since diagnosis||6.7 years|
|Ann Arbor stage III/IV||93%|
|Baseline cytopenias, grade ≥1†|
Neutropenia Anemia Thrombocytopenia
|Prior regimens, median (range)||4 (2-9)|
|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 (<LLN). 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 SLL.
BR=bendamustine, rituximab; FCR=fludarabine, cyclophosphamide, rituximab; R-CHOP=rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone.