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Idelalisib: Analysis of Pivotal Data Jeff Sharman M.D. Willamette Valley Cancer Institute Eugene Oregon US Oncology Research

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Disclosures Consulting: Gilead, Pharmacyclics, Celgene Research Funding: Gilead, Pharmacyclics, Genentech, Seattle Genetics, Celgene, Novartis, TG Therapeutics Honoraria: Gilead, Genentech

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US Labeled Indications Indications referenced from: https://www.zydelig.com/hcp/

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StrategyORRPFS Byrd JCO 2001 Intensification 3x weekly45%10 Months OBrien JCO 2001 Escalation 500-2250 mg/m236%8 Months Monotherapy Publications

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Patterns of Care ConnectUS OncologyConnectUS Oncology FCR/PCR3217184 R-Benda27333843 Rituximab14211824 Flu +/- Ritux10513- Chlorambucil753- First Line Therapy Second Line Therapy 1)Sharman et al ASH 2011 2)Market Connect / McKesson Specialty Health

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Single agent idelalisib 101-02 Study Brown et al Blood 2014

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Single agent idelalisib 101-02 Study

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Idelalisib Combination 101-07 Study Sharman et al ASH 2011

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Idelalisib Combination 101-07 Study Sharman et al ASH 2011

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CLL Registration Study

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Healthy Volunteer Trials Dose-ranging Metabolism Hematologic Cancer Trials Single-agent (101-02 Study) Combination (101-07 Study) Combination (101-08 Study) Full Development 2011-2016 Early Development 2008-2010 Refractory iNHL Phase 2 single-agent (101-09 Study) Previously treated iNHL Phase 3 combination immuno or chemoimmunotherapy 124 Study: R GS-1101 125 Study: BR GS-1101 iNHL Accelerated Approval iNHL Full Approval Previously treated CLL Phase 3 combination with CD-20 mAb 116/117 Study: R GS-1101 119 Study: Ofa GS-1101 CLL Full Approval Additional studies lymphoid malignancies Exploration & Indication Expansion Previously treated CLL Phase 3 combination with chemoimmunotherapy 115 Study: BR GS-1101 Study Context

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in patients for whom rituximab alone would be considered appropriate therapy due to other comorbidities CharacteristicPercentageMedian Age > 6578%71 Cr Clearance < 6040%64 ml/min Grade 3 Marrow35% CIRS > 685%8

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Treatment Disposition Coutre et al ASCO 2014

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Outcomes Coutre et al ASCO 2014

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Black Box - Grade 5 Toxicity Grade 5 Hepatotoxicity 1/1192 = 0.1% Diarrhea 1/1192 =