Single-agent ZYDELIG® delivers powerful efficacy in relapsed/refractory follicular lymphoma

ZYDELIG is indicated for relapsed follicular lymphoma in patients who have received at least two prior systemic therapies

ZYDELIG is the most prescribed therapy for 3rd-line+ follicular lymphoma*

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) RECOMMEND idelalisib (ZYDELIG) monotherapy as an option for appropriate patients with relapsed/refractory follicular lymphoma2†

Pivotal phase 2, single-arm, open-label study (N=125)3,4‡

Key eligibility criteria

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

ZYDELIG 150 mg po BID
Follicular lymphoma: n=72

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 population3,5

4.7
Median years
since diagnosis
4
Median number of
prior therapies
100%
Double Refractory
~80%
Experienced early disease progression (within 24 months of first-line chemoimmunotherapy)#
Patient baseline characteristics (n=72)3,4

Median age (range), years

62 (33-84)

Prior therapies,** median (range)

4 (2-12)

Refractory

To rituximab and an alkylator

%

100

High disease burden

FLIPI

%

Low (≤1)

21

Intermediate (2)

25

High (≥3)

54

Ann Arbor stage III/IV

83

Bulky disease††

22

Baseline cytopenias,‡‡ any grade

%

Neutropenia

24

Anemia

42

Thrombocytopenia

33

Safety profile in relapsed
follicular lymphoma

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Adverse event monitoring
& management

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Healthcare professional
resources

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*IntrinsiQ, May 2015-December 2017.

†Please see the complete version of the NCCN Guidelines® for B-cell Lymphomas (V.1.2018) 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 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 who failed to respond or relapsed within 6 months of receiving rituximab and an alkylator.

#Among follicular lymphoma patients in the study (n=72), 37 of the 46 who received first-line chemoimmunotherapy had early disease progression.5

**Most common prior regimens: 50% BR, 49% R-CHOP, and 28% R-CVP.

††Bulky disease was defined as the presence of at least 1 lymph node with at least 1 dimension of ≥7 cm.3

‡‡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/mm3.3,8

ANC=absolute neutrophil count; BID=twice daily; BR=bendamustine, rituximab; CI=confidence interval; CR=complete response; DoR=duration of response; FLIPI=Follicular Lymphoma International Prognostic Index; 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; R-CVP=rituximab, cyclophosphamide, vincristine sulfate, prednisone; TTR=time to response.

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 B-cell Lymphomas V.1.2018. © 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. Gopal AK, Kahl BS, Flowers CR, et al. Idelalisib is effective in patients with high-risk follicular lymphoma and early relapse after initial chemoimmunotherapy. Blood. 2017;129(22):3037-3039.
  6. Salles G, Schuster SJ, de Vos S, et al. Efficacy and safety of idelalisib in patients with relapsed, rituximab- and alkylating agent-refractory follicular lymphoma: a subgroup analysis of a phase 2 study. Haematologica. 2017;102(4):e156-e159.
  7. Salles G, Schuster SJ, de Vos S, et al. Supplement to: Efficacy and safety of idelalisib in patients with relapsed, rituximab- and alkylating agent-refractory follicular lymphoma: a subgroup analysis of a phase 2 study. Haematologica. 2017;102(4):e156-e159.
  8. 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).