The information on this site is intended for US healthcare professionals and clinical staff only.
ZYDELIG is indicated for relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior systemic therapies
NCCN Guidelines® recommend idelalisib (ZYDELIG) monotherapy as an option for appropriate patients with relapsed/refractory SLL2*
Key eligibility criteria
ZYDELIG 150 mg po BID
SLL: n=26
Therapy maintained until disease progression or unacceptable toxicity
Primary endpoint:
ORR‡
Secondary endpoints included:
DoR,§ TTR
Studied in a clinically challenging patient population3,4
Median age (range), years
65 (50-87)
Prior therapies,# median (range)
4 (2-9)
Refractory
%
To rituximab and an alkylator
100
High disease burden
%
Ann Arbor stage III/IV
100
Baseline cytopenias,** any grade
%
Neutropenia
31
Anemia
65
Thrombocytopenia
35
All PRs achieved; no patients achieved a CR
Pinch to zoom
Pinch to zoom
Pinch to zoom
*Please see the complete version of the NCCN Guidelines® for CLL/SLL (V.3.2018) available on NCCN.org for specific recommendations.
†The study population included patients with follicular lymphoma, small lymphocytic lymphoma, marginal-zone lymphoma, or lymphoplasmacytic lymphoma with or without Waldenström macroglobulinemia.3
‡ORR was defined as the proportion of patients who achieved a CR or PR. Responses were assessed by an IRC.3
§DoR was measured from the onset of response to disease progression.3
||Double refractory defined as patients that failed to respond or relapsed within 6 months of receiving rituximab and an alkylator.
¶Bulky disease was defined as the presence of at least 1 lymph node with at least 1 dimension of ≥7 cm.3
#Most common prior regimens: 81% BR, 62% FCR, and 35% R-CHOP.
**Cytopenias were defined as blood cell counts <LLN. Anemia was defined as a hemoglobin level <10 g/dL, neutropenia as an absolute neutrophil count <1500/mm3, and thrombocytopenia as a platelet count <75,000/mm3.3,5
BID=twice daily; BR=bendamustine, rituximab; CI=confidence interval; CR=complete response; DoR=duration of response; FCR=fludarabine, cyclophosphamide, rituximab;
IRC=independent review committee; LLN=lower limit of normal; NCCN=National Comprehensive Cancer Network; ORR=overall response rate; PLT=platelet count; po=orally;
PR=partial response; PS=performance status; R-CHOP=rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone.
References: