What is the Optimal Front-Line Treatment for mrcc? Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center

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1 What is the Optimal Front-Line Treatment for mrcc? Michael B. Atkins, MD Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center

2 The Case for Immunotherapy in mrcc 1. Achieves patient s goal 2. Positive randomized trials for the most desirable endpoints (IL-2) 3. Results improving with practice (IL-2) 4. Improving therapeutic index (anti-pd1) 5. Patient selection possible expanded population 6. Promising combinations in development 7. No negative impact on subsequent VEGFR therapy

3 Probability of survival 1) Achieves the Patient s Goal 1.0 Treatment Ends Benefit Persists Probability of continuing response Duration of survival (mo) 140 Fisher R, et al. Cancer J Sci Amer. 2000;6(suppl 1):S55-S57.

4 Positive Phase III Trials for meaningful endpoints (Durable CR, 3 year PFS) Regimen N RR p-value Dur CR NCI SB CWG HD IV IL % 8 vs 0.05 LD IV IL % 3 HD IV IL % 7 vs 0.02 LD SC IL-2/IFN 91 10% 0 More durable responses (9 vs 1), especially CRs (7 vs 0; p =0.01), with HD IL-2 Subsets showed improved survival with HD IL-2 vs LD IL-2/IFN Yang et al JCO 2003; McDermott et al JCO 2005

5 Results improving over time: Activity of IL-2 is greater than package Insert Response* % Historical rate 14 IL-2 Select Trial (all pts n=120)* 28 p= % CI= % Likely explanations for improved RR include: 1) Enhanced pre-screening - smaller non-clear cell population 2) Application of debulking nephrectomy - fewer patients treated with primary in place *Using WHO Criteria McDermott et al ASCO 2010

6 Maximum % Change in Target Lesions Tumor Shrinkage Plot (n=118) Should be treated PR

7 Phase I Nivolumab: RCC cohort (n=34) Generally tolerable: fatigue, rash, pruritus, diarrhea - 3 deaths: pneumonitis (non-rcc) Preliminary efficacy in heavily pre-treated patients: - 29% objective responses - Median PFS 7.3 months 6 months All stopped therapy Treatment - Free Survival (TFS) Drake ASCO 2013

8 Responders ESMO 2014 Duration of response by dose 0.3 mg/kg (n = 12) 2 mg/kg (n = 12) 10 mg/kg (n = 11) Time (months) Time to response Ongoing response Based on data cutoff of March 5,

9 Treatment-related adverse events ( 10% of patients in any arm) ESMO 2014 Nivolumab, mg/kg 0.3 (n = 59) 2.0 (n = 54) 10 (n = 54) Patients with event, % Any grade Grade 3/4 Any grade Grade 3/4 Any grade Grade 3/4 Any event Fatigue Nausea Pruritus Rash Diarrhea Appetite decreased Dry mouth Dry skin Hypersensitivity Arthralgia

10 PD-1 Pathway Blockade Activity in RCC Agent(s) Trial Setting n RR (%) PFS(mo) Nivo 1 Phase 1 TKI Failure MPDL3280A 2 Phase 1 Mostly Prior Rx Nivo 3 Phase 2 TKI Failure Nivo 4 Biomarker TKI Failure Naive low 1 Topalian et al, NEJM, 2012, 2 McDermott et al ESMO 2014, 3 Motzer et al ESMO 2014, 4 Choueiri et al, ASCO 2014

11 *Totally unbiased survey of panel of experts in RCC therapy

12 Patient Selection May be Possible UK Group Results based on Predictive Histology Models High-dose Interleukin-2 Can Produce a High Rate of Response and Durable Remissions in Appropriately Selected Patients With Metastatic Renal Cancer. Shablak, Alaaeldin; Sikand, Kanwal; Shanks, Jonathan; Thistlethwaite, Fiona; Spencer-Shaw, Andrea; Hawkins, Robert Journal of Immunotherapy. 34(1): , January DOI: /CJI.0b013e3181fb659f 2011 Lippincott Williams & Wilkins, Inc. Published by Lippincott Williams & Wilkins, Inc. 2

13 Tumor grade and response to PD-1 Blockade Nivolumab Phase 1 Trial ORR = 29% (n=34) ORR by tumor grade based on path reports Grade 1/2 18% Grade 3/4 45% (9/20) Grade 4 62% (5/8) More aggressive tumors respond. Complementary to population that responds to HD IL-2

14 PD-L1 Expression and Response in RCC Agent(s) Trial n RR (%) PD-L1 pos RR(%) PD-L1 neg Nivo 1 Phase % 0% MPDL3280A 2 Phase % 10% Nivo 3 Phase % 18% Nivo 4 Biomarker 56 22% 8% 1 Topalian et al, NEJM, 2012, 2 McDermott et al ESMO 2014, 3 Motzer et al ESMO 2014, 4 Choueiri et al, ASCO 2014

15 Promising Combinations: Nivo + Ipi Confirmed ORR, n (%) 95% CI N3 + I1 (n = 21) N1 + I3 (n = 23) 9 (43) (48) Median duration of response (DOR), weeks 31.1 ( ) b NR ( ) c (range) a Ongoing responses, % (n/n) 78 (7/9) 82 (9/11) Best objective response, n (%) d Complete response Partial response Stable disease Progressive disease Unable to determine 0 9 (43) 5 (24) 5 (24) 1 (5) 1 (4) 10 (43) 8 (35) 3 (13) 1 (4) a Due to the high percentage of ongoing responses, median duration of response may be misleading; b Median follow-up 36.1 weeks; c Median follow-up 40.1 weeks; d Excludes unconfirmed responses. DOR defined as time between date of first response and date of disease progression or death (whichever occurs first). 15

16 Change in baseline target lesions (%) Change in baseline (%) Hammers #4504 New combination studies in mrcc : Nivolumab + Ipilimumab Nivo3 + Ipi (n=20) Nivo1 + Ipi3 (n=22) 1st occurrence of new lesion Time since first dose (weeks) Time since first dose (weeks) N3 + I1 (n=20) Time since first dose (weeks) N1 + I3 (n=22)

17 Nivolumab Front Line Phase 3 Trial mrcc Treatment Naive Ipi 1/ Nivo 3 IV every 3 wks Sunitinib 50 mg po QD x 4 weeks q 6 weeks Trial anticipated to start in 2014

18 Sequential Therapy-Immunotherapy first may maximize patient options (outcomes) VEGF targeted therapy is active following cytokine failure Sunitinib and axitinib produce > 40% RR Sorafenib activity the same after IFN failure as first-line Median OS in IL-2 Select Trial mos

19 IL-2 Select Trial Results- Median PFS and OS 19

20 What is the Optimal Front-line Treatment for mrcc? Immunotherapy is IT

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