Urothelial Cancers- New Strategies. Sandy Srinivas.MD Stanford University
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1 Urothelial Cancers- New Strategies Sandy Srinivas.MD Stanford University
2 Relevant financial relationships in the past twelve months by presenter or spouse/partner. Consultant: Genentech, Astra Zeneca The speaker will directly disclosure the use of products for which are not labeled (e.g., off label use) or if the product is still investigational. 14 th Annual California Cancer Conference Consortium August 10-12, 2018
3 Outline Chemotherapy Targeted therapy Immunotherapy Adjuvant/Neoadjuvant
4 Neoadjuvant chemotherapy in UC Standard of care in ct2 Bladder cancer Goal is to achieve a pt0 <pt2 results have better outcomes and are acceptable endpoints Cis/gem or DD MVAC commonly used
5 Dose Dense Gemcitabine/Cisplatin Gemcitabine :2500mg/m2 Day 1. Cisplatin: 35mg/m2 days 1,2; Q 2 weeks X 6 cycles N=49 (%) P<T2 57 pt0 15 Dose modifications RESULTS 39 Grade3/ cycles 67 Iyer, JCO 2018
6 Risk adapted strategies to spare cystectomy A ct0/cis observation Dd GC X6 DDR del Molecular Stratification >T1 cystectomy DDR wt cystectomy
7 Neoadjuvant Check point inhibitors in UC Cis Ineligible Cis Eligible
8 POUT: Perioperative Chemotherapy vs Surveillance in Upper Tract Urothelial Cancer Randomized phase III trial 4 x 21-day cycles Pts with invasive UTUC* within 90 days after nephroureterectomy; WHO PS 0/1; GFR 30 ml/min (N = 261 ) *pt2-4, pn0, M0 or ptany, N1-3, M0. n = 1 withdrew consent. Gemcitabine 1000 mg/m 2 D1, 8 + Cisplatin 70 mg/m 2 D1 (if GFR 50 ml/min) or Carboplatin AUC 4.5/AUC 5 D1 (if GFR ml/min) (n = 131) Surveillance (n = 129) Pts followed every 3 mos for 1 yr, every 6 mos for 2 more yrs, then annually Primary endpoint: DFS Secondary endpoints including: acute and late toxicity, metastasis-free survival, treatment compliance, feasibility of recruitment, OS Birtle AJ, et al. ASCO GU Abstract 407.
9 POUT: Disease-Free Survival (Primary Endpoint) 2-yr DFS: 71% with chemotherapy vs 54% with surveillance HR: 0.49 (95% CI: ; P =.001) HR adjusted for nodal involvement, microscopic margin status, planned chemotherapy type: 0.47 (95% CI: ; P =.001) Variable n Univariable HR P Value Overall ( ).001 Nodal involvement N0 N+ Planned chemotherapy Gem-Cis Gem-Carbo Microscopic margin status Positive Negative ( ) 0.85 ( ) 0.40 ( ) 0.67 ( ) 0.56 ( ) 0.44 ( ) Birtle AJ, et al. ASCO GU Abstract 407.
10 POUT: Key Secondary Endpoints 2-yr metastasis-free survival: 74% with chemotherapy vs 60% with surveillance HR: 0.49 (95% CI: ; P =.002) HR adjusted for nodal involvement, microscopic margin status, planned chemotherapy type: 0.47 (95% CI: ; P =.002) OS data immature (HR: 0.55) 67.9% of pts in chemotherapy arm received maximum number of cycles (4) with 6 pts still undergoing treatment 12.9% of pts who received cisplatin at start of treatment switched to carboplatin Birtle AJ, et al. ASCO GU Abstract 407.
11 Outline Chemotherapy Targeted therapy Immunotherapy Adjuvant/Neoadjuvant
12 Phase 2 study of Erdafitinib (ERDA; JNJ ) in patients (pts) with metastatic or unresectable urothelial carcinoma (muc) and FGFR alterations FGFR alterations muc-15-20% Upper tract % NMIBC-40-70% Erdafitinib is a Pan FGFR inhibitor 1-4
13 Patient Characteristics/Results
14 Adverse Events/Future Directions
15 Enfortumab vedotin phase 1 (EV-101) study in patients with metastatic urothelial cancer (muc). EV 101: Demographics and Disease Characteristics
16
17 PARP inhibitors Rucaparib ATLAS Non enriched NCT Olaparib Enriched NCT Olaparib+Durvalumab BISCAY Cis- Eligible NCT Olaparib +Durvalumab BAYOU Cis-ineligible NCT Rimar Cancer 2017
18 Outline Chemotherapy Targeted therapy Immunotherapy Adjuvant/Neoadjuvant
19 CPI in Cisplatin Refractory Disease Drug Target N ORR (%) CR (%) PFS (mos) OS (mos) 1yr Sur (%) FDA approval Atezolizumab PDL Accelerated 2016 Pembrolizumab PD Nivolumab PD Accelerated 2017 Durvalumab PDL Break through2017 Avelumab PDL Accelerated 2017 Summary- All CPI inhibitors active in Post platinum disease; ORR-15-26%; Small fraction with CR; Pembrolizumab demonstrating superiority to chemotherapy Rosenberg JE, et al. Lancet. 2016;387: Sharma P, et al. Lancet Oncol. 2017;18: ; Apolo AB, et al. J Clin Oncol. 2017;35: ;Powles T, et al. JAMA Oncol. 2017;3:e
20 CPI in cis ineligible Patients Best Chemotherapy Regimen: Carboplatin/Gemcitabine ORR- 36%; PFS-5.8 mos; OS-9.3 mos Drug N ORR (%) CR (%) PFS OS Atezolizumb ImVigor 210 Pembrolizumab KN mos OS- 67% Performance status 2 Hearing loss grade 2 Peripheral neuropathy grade 2 NYHA Class III CrCl < 60 ml/min Bellmunt Ann 2017 ; Balar Lancet 2017
21 PDL 1 as a biomarker Issues with PDL1 Multiple assays Primary vs met Timing of testing Patients with negative tests achieve CR Cut off for positivity Test on TC vs IC
22 FDA alert May 18, Label Change- Atezolizumab/Pembrolizumab FDA issued an alert that preliminary data analysis shows a decrease in survival for bladder cancer patients with low PDL1 receiving mono- immunotherapy with pembrolizumab in KN 361or atezolizumab in Imvigor 130 versus chemotherapy as first-line therapy, Cis eligible patients: CISPLATIN Cis Ineligible pts Trial N Opened Est. Complete End Point Carbo eligible? Atezolizumab 2 Atezolizumab + cisplatin or carboplatin/gemcitabine Cisplatin or carboplatin/gemcitabine 1200 June 2016 July 2020 PFS/OS/AE YES PDL1 NO Pembrolizumab 3 Pembrolizumab + cisplatin or carboplatin/gemcitabine Cisplatin or carboplatin/gemcitabine 990 September 2016 May 2020 PFS/OS Low High Carbo chemo CPI
23 Mutation Load/MB Probability of OS (%) Probability of OS (%) Mutation Load/MB Mutation Load and Survival With Immunotherapy IMvigor210 Cohort 1 [1] IMvigor210 Cohort 2 [2] Responses by Mutation Load [2] Responder/Nonresponder P < CR/PR SD/PD/NE Objective Response Status Days Mutation Load (Range) Q4: (> 16 to 62.2) Q3: (> 8.1 to 16) Q2: (> 5.4 to 8.1) Q1: ( 0.9 to 5.4) Days Q4: ( 13.5 to 46.8) Q3: (> 8.1 to 13.5) Mutation Load (Range) Q2: (> 5.4 to 8.1) Q1: (> 0.1 to 8.1) CR PR SD PD NE 1. Balar AV, et al. Lancet. 2017;389: Loriot Y, et al. ESMO Abstract 783P.
24 Deletrious DDR Alterations and Response to CPI N=60 (%) ORR (%) PFS (mos) Any DDR vs vs 2.9 Likely deleterious OS (mos) vs 19 NR NR 23 vs 9.3 Teo JCO 2018;
25 Adjuvant Therapy : Clinical Trials With CPI Trial Name Treatments # patients Population IMvigor0101 [1] CheckMate 274 [2] AMBASSADOR [3] Atezolizumab vs observation Nivolumab vs placebo Pembrolizum ab vs observation With neoadjuvant: ypt2 4a or ypn+ (ypt2-4 or ypn+ for UTUC) Without neoadjuvant: pt3 T4a or pn+ (pt3-4 or pn+ for UTUC) With neoadjuvant: ypt2-pt4a or ypn+ Without neoadjuvant: ypt3-pt4a or ypn+ With neoadjuvant: pt2 and/or N+ Without neoadjuvant: pt3 or pn+ Primary Endpoint DFS DFS DFS, OS 1. NCT NCT NCT
26 First-line Combination Trials in Platinum-Eligible/Ineligible Pts Trial N Opened Est. Complete End Point Durvalumab (MEDI4736) 1 Durvalumab/tremelimumab Cisplatin or carboplatin/gemcitabine 1200 November 2015 September 2019 OS Atezolizumab 2 Atezolizumab + cisplatin or carboplatin/gemcitabine Cisplatin or carboplatin/gemcitabine 1200 June 2016 July 2020 PFS/OS/AE Pembrolizumab 3 Pembrolizumab + cisplatin or carboplatin/gemcitabine Cisplatin or carboplatin/gemcitabine 990 September 2016 May 2020 PFS/OS Ipilimumab + nivolumab 4 Nivolumab + cisplatin/gemcitabine* Cisplatin or carboplatin/gemcitabine 897 March 2017 December 2022 PFS/OS 1.NCT ;2. NCT ; 3.NCT ; 4.NCT
27 Maintenance Immunotherapy Following First-line Platinum-Based CT First-line platinum CT Dose dense MVAC Cisplatin/gemcitabine Carboplatin/gemcitabine Radiographic assessment following chemotherapy cycles CR/PR/SD PD SoC Maintenance trial Immunotherapy Placebo or BSC Trial N Chemotherapy Duration Primary Endpoint Estimated Completion Phase II NCT [1] Pembrolizumab vs Placebo (up to 24 mos) Phase III JAVELIN Bladder 100 [2] Avelumab vs BSC 200 Up to 8 cycles 6-mo PFS November cycles OS July ClinicalTrials.gov. NCT ClinicalTrials.gov. NCT
28 Challenges No predictive biomarker Low responses Unclear duration of therapy in responders Best setting to use- First line chemo? Adjuvant? Neoadjuvant? Will sequence of therapy matter Is re-treatment an option? Post CPI unmet need? Combination
29 Looking Forward CISPLATIN ELIGIBLE CISPLATIN INELIGIBLE NOW FUTURE NOW FUTURE FIRST LINE CIS/GEM DD MVAC IO +IO IO+ CHEMO Atezo/Pembro Carbo/Gem IO +Novel agent SECOND LINE IO IO+ NOVEL AGENT Carbo/gem IO IO +Novel agent NEOADJUVANT CIS/GEM DD MVAC ADJUVANT NONE IO IO+IO IO+IO IO + CIS/GEM IO+ DD MVAC NONE NONE IO +Novel agent IO +Novel agent Novel agents: TKI- FGFRI; VEGFRI; PARPI, immuno-drug conjugate
30 Roberston Cell 2017 Molecular Classification- pick therapies
31 Systemic Treatments in UC-2018 NMIBC BCG Neo adjuvant DD MVAC Cis-Gem First Line Second Line Third Line??? Cis eligible: MVAC DD MVAC Cis/gem Cis-ineligible Carbo/gem PDL1 high: atezo/pembro Atezolizumab Pembrolizumab Nivolumab Durvalumab Avelumab FGFR Immune Drug-conj PARPI TKI s
32 Thank
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