BCG Unresponsive Disease A Roadmap for Drug Development and Integra;on of Novel Therapies

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1 BCG Unresponsive Disease A Roadmap for Drug Development and Integra;on of Novel Therapies Seth P. Lerner, MD, FACS Professor of Urology Beth and Dave Swalm Chair in Urologic Oncology Baylor College of Medicine, Houston, Texas Future DirecEons in Urology August 19, 2017

2 Disclosures Clinical trials Endo, FKD, VivenEa NCI/SWOG Roche/Genentech, JBL Advisory Board BioCancell, Incyte, Nucleix, UroGen Consultant Biocancell, UroGen, Vaxiion 2

3 BCG Indica;ons Any paeent with high risk NMIBC TaHG, T1, Tis; mulefocal and recurrent and >3cm TaLG First occurrence standard of care Recurrent BCG naïve BCG failure (induceon) if no indicaeon for cystectomy or medically unfit FDA approved for CIS and high risk Ta,T1 3

4 Failure to Achieve a CR at 3 Months Status at 3 month cysto associated with outcome EORTC affirmed 3 years of maintenance BCG as standard of care for high risk NMIBC Lerner, et al Secondary analysis of SWOG 8507 Urologic Oncology 27:155,

5 Outcomes Following BCG Table 3 Multivariable analysis of disease-related variables and the associated risk of treatment failure in BCG failure patients with (A) any recurrent CIS or (B) recurrent pure papillary disease treated with intravesical BCG/IFN. (N denotes sample size) Note: # signifies that there was no significant difference between these two groups (A) Treatment Failure Level N HR 95% CI P-value Number of Prior BCG Courses 2 courses <.01 1 courses 55 Ref Prior BCG Failure Interval <6 Months <.01 # 6 12 Months >12 Months 28 Ref Total 98 (B) Treatment Failure Kaplan-Meier plot of treatment success of intravesical BCG/IFN in BCG Failure patients with recurrent CIS stratified by prior BCG failure interval and number of prior BCG failures including number at-risk. Images in this article Both prior BCG therapy and interval from last BCG are independently associated with recurrence probability Steinberg, et al Bladder Cancer 2:215,

6 Cystectomy is the Standard of Care for Pa;ents Who are Medically Fit 6

7 Cystectomy is the Standard of Care for Pa;ents Who are Medically Fit AUA 2016 In a high- risk paeent with persistent or recurrent disease within one year following treatment with two induceon cycles of BCG or BCG maintenance, a clinician should offer radical cystectomy. (Moderate RecommendaEon; Evidence Strength: Grade C) 7

8 Early vs. Delayed Cystectomy 105 pts, T1G3 with at least 2 risk factors CIS, large tumor, mulefocality) 51 refused cystectomy and treated with BCG. All ulemately had a delayed cystectomy (avg 11 months later) Cystectomy done at first sign of recurrence T1 or TIS or T2 (34%) Ø 5 yr CSS 83% vs. 67% Ganzinger Eur Urol 53:146,

9 Cystectomy in BCG Failure for CIS Long- term cancer control rates opemal with RC n=52 with CIS only at the ;me of RC All paeent underwent extended LND to IMA No paeent had lymph node metastasis 5- and 10- year RFS rates were 94% and 90%, Zahnder, et al BJU Int Jan

10 When BCG Fails the Pa;ent BCG/IFN for paeents treated with induceon only Valrubicin only FDA approved drug Gemcitabine OpEmized MMC Gem/MMC Gem/Docetaxel Clinical trial 10

11 Valrubicin 80 paeents with CIS 39% had at least 2 prior courses of BCG Received 6 or 9 weeks of Valrubicin 35% NED at 3 months THINK (posieve cytology allowed) CR at 6 months 18% 4% disease- free at 2 years Dinney et al Urol Onc 31:1635,2013

12 Gemcitabine SWOG S paeents all failed 2 courses BCG 89% high risk, 60% CIS 6 weekly treatments 2g in 100cc, then monthly x 12 Results: Ø 47% NED at 3 months Ø 28% conenuously disease- free at 12 mos Skinner J Urol 190:1200,

13 Gemcitabine/Docetaxel 45 paeents treated over 5 years InducEon only TaLG (4); TaHG (13) CIS (20); T1HG (8) 66% 54% 33% Steinberg, et al Bladder Cancer 1:65,

14 Device- assisted Chemotherapy Synergo microwave with MMC 1 51 paeents with CIS 34 failed prior BCG, 17 refractory (not reported separately) CR at 3 months 88% 22/45 (49%) recurred with median f/u 22 months 6 cystectomies ElectromoEve MMC (EMDA) promising US trials in BCG- recurrent paeents in planning phase 1 Witjes et al World J Urol 2009;27:319 14

15 Bladder Cancer Drug Development Valrubicin approved in 1998 BCG refractory CIS in paeents who refuse or are medically unfit for cystectomy No new drugs approved unel May 2016 Atezolizumab Now 5 immunotherapy agents targeeng PD1- PD- L1 gained accelerated or condieonal approval in metastaec disease plaenum refractory or plaenum ineligible

16 Bladder Cancer Drug Development Must have a drug approval process that is transparent and achievable Challenges: Therapy vs. adjuvant Mixed disease stage Ta/T1 and CIS. Adjuvant requires a control arm in order to power for treatment effect Unethical to have a no treatment control arm and only the approved drug does not have a favorable enough treatment effect

17 FDA/AUA/SUO Guidance Urology 83:262, /30/ /26/2015 SUO- CTC sponsored joint meeeng with CDER and CBER at FDA 4/18/

18 BCG Unresponsive high risk NMIBC Recurrent/persistent high grade urothelial carcinoma aoer compleeon of at least induceon and one cycle maintenance BCG ( 5+2 ) for high grade Ta/T1 or CIS Never achieved CR or recurred within 6 months of last BCG dose T1HG at first evaluaeon aoer induceon BCG at least 5 of 6 induceon doses These paeents are extremely unlikely to respond to further BCG Lerner et al, Bladder Cancer 1:29, 2015)

19 DraW FDA Guidance November

20 Clinical Trial Design FDA Guidance Randomizing paeents with BCG- unresponsive disease to a minimally effeceve drug as a concurrent control raises ethical concerns. Because effeceve drugs are not available and the alternaeve treatment is cystectomy, single- arm trials of paeents with BCG unresponsive CIS disease with or without papillary disease are appropriate. Primary endpoint should be complete response in paeents with CIS 20

21 Clinical Trials Ad- IFN gene therapy (FKD) SUO- CTC Viccinium (VivenEa) Atezolizumab (SWOG S Roche/GNE) Pembrolizumab (Merck) Nab- Rapamycin- ABI- 009 Phase I/II (AADi LLC) Cabazitaxel, gemcitabine, and cisplaen Phase I (Columbia) BGJ 398 FGFR targeted therapy (MSKCC) ChemoXRT for T1 (RTOG 0926) 21

22 Ad- IFN (FKD/SUOCTC) A Phase III, Open Label Study to Evaluate the Safety and Efficacy of INSTILADRIN (rad- IFN/ Syn3) Administered Intravesically to PaEents with High Grade, BCG Unresponsive, NMIBC PI - Boorjian Primary aim: To evaluate the incidence of HG Event- Free Survival at 12 months Treatment: Ad/IFN 3 x 1011 vp/ml135 paeents; 35 responding paeents at 12 months (RR 25.2%, 95% CI = [18.1%, 33.4%])

23 Ad- IFN (FKD/SUOCTC) Intravesical dosing at 3 month intervals x 4; mos 1,4,7,10 Responding paeents may conenue treatment year 2

24 S1605: Phase 2 trial of Atezolizumab in BCG-unresponsive non-muscle invasive bladder cancer. (PI Peter Black) Rationale: High risk NMIBC responds to immunotherapy PDL1 is expressed in NMIBC 1 Encouraging results in metastatic disease 2,3 Hypothesis: checkpoint molecules facilitate immune evasion in BCG-unresponsive NMIBC and this can be overcome with checkpoint inhibitors 1 Inman et al, Cancer Powles et al, Nature Rosenberg, Lancet 2016

25 Study Scheme BCG unresponsive Ta/T1/Tis (TURBT) Atezolizumab Atezolizumab Atezolizumab q 3 weeks Atezolizumab registration within 6 weeks of TURBT start therapy within 5 days of registration Atezolizumab cysto cytol Atezolizumab Atezolizumab Atezolizumab 13 wks* q 3 weeks Atezolizumab cysto biopsy cytol Atezolizumab maintenance q3wks for 9 cycles 25 weeks* (=6 months post TURBT) surveillance for 18 mo. 18 months * time is relative to first dose of atezolizumab

26 Co-Primary Endpoints 1. Complete response (CR) in patients with CIS negative cytology, cystoscopy, biopsy at 6 months (n = 70) if 28 (40%) or more patients respond, the agent would be considered promising 2. Event-free survival (EFS) at 18 months for overall study cohort recurrence = any high grade tumor or any metastasis

27 Take Home Message BCG Unresponsive state is unlikely to respond to addieonal BCG ± IFN and is associated with increased risk for progression to muscle invasive disease Radical cystectomy has a high probability of long term cancer control and is standard of care per current Guidelines 27

28 Take Home Message FDA in collaboraeon with muleple stakeholders has defined a registraeon pathway via a single arm trial design with efficacy determined by inieal and durable CR for CIS Intravesical therapy and clinical trials of new agents are appropriate for those paeents who do not need immediate cystectomy, refuse or are medically unfit for cystectomy 28

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