Single-agent ZYDELIG® demonstrates durable responses in relapsed/refractory SLL

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*

Pivotal phase 2, single-arm, open-label study (N=125)3†

Key eligibility criteria

  • Double refractory: Failed to respond or relapsed within 6 months following therapy with rituximab and an alkylator
  • Karnofsky PS ≥60
  • ANC ≥1.0 x 109/L and PLTs ≥50 x 109/L

ZYDELIG 150 mg po BID
SLL: n=26

Therapy maintained until disease progression or unacceptable toxicity

Primary endpoint:
ORR

Secondary endpoints included:
DoR,§ TTR

  • Median follow-up 9.7 months3

Studied in a clinically challenging patient population3,4

6.7
Median years
since diagnosis
4
Median number of
prior therapies
100%
Double refractory||
46%
Bulky Disease
Patient baseline characteristics3,4

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

Safety profile in relapsed SLL

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Adverse event monitoring
& management

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Healthcare professional
resources

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*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:

  1. ZYDELIG® (idelalisib) [prescribing information]. Foster City, CA: Gilead Sciences, Inc.; rev January 2018.
  2. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.3.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed February 23, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  3. Gopal AK, Kahl BS, de Vos S, et al. PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370(11):1008-1018.
  4. Data on file. Gilead Sciences, Inc. 2018.
  5. US Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE), Version 4.0. Published May 28, 2009 (v4.03: June 14, 2010).