Riunione Monotematica A.I.S.F The future of liver diseases. HEPATIC NEOPLASMS The challenge for new drugs

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1 Riunione Monotematica A.I.S.F The future of liver diseases Milan 13 th -15 th October 2016 Centro Congressi Fondazione Cariplo HEPATIC NEOPLASMS The challenge for new drugs Massimo Iavarone Gastroenterology and Hepatology Unit Fondazione IRCCS Ca Granda Maggiore Hospital Università degli Studi Milan

2 Financial Disclosures Dr. Massimo Iavarone Grant and research support: BMS, Gilead Science Speaking and teaching: Bayer, Gilead Science, Janssen, BTG, Abbvie

3 Outline Sorafenib, 8 yrs later From trials to clinical practice Adjuvant therapy New drugs Failures Encouraging results Future perspectives

4 Llovet JM et al, Nat Rev Clin Oncol 2015 Molecular Targeted Therapies for HCC Their Target Signalling Pathways

5 Sorafenib improved overall survival in patients with advanced HCC SHARP Asia Pacific SHARP Asia Pacific Median, sorafenib 10.7 months 6.5 months Median, placebo 7.9 months 4.2 months Hazard ratio (95% CI) 0.69 ( ) 0.68 ( ) Llovet JM, et al. N Engl J Med 2008; Cheng A-L, et al. Lancet Oncol 2009.

6 Sorafenib The Good Use in Clinical Practice, 8 yrs later GIDEON Study SOFIA Study 21.6 months (95% CI ) vs 9.6 months (95% CI ) Iavarone M et al, Hepatology 2011; Marrero J et al, ASCO 2013 abs # 4126.

7 Adherence to BCLC indications in 30 non-referral centers ( : 536 HCC patients) Patients treated with sorafenib for HCC in Italy in clinical practice Borzio M, et al. Future Oncology 2013; data from Aifa-Rfom and data-on-file Bayer

8 Molecular therapies under evaluation in HCC Last check 2011 Villanueva A et al, Gastroenterology 2011

9 Phase III First-line Targeted Drug Trials for HCC Agent Target OS vs Sorafenib Mos Trial Number Reason for failure Sunitinib VEGFR, PDGFR, FLT3, KIT, RET 7.9 vs 10.2 NCT Brivanib VEGFR, FGFR 9.5 vs 9.9 NCT Linifanib VEGFR, PDGFR 9.1 vs 9.8 NCT Erlotinib/Sor EGFR 9.5 vs 8.5 NCT Lack of efficacy and severe toxicity Lack of efficacy and toxicity Lack of efficacy and toxicity Lack of efficacy and toxicity Doxorubicin/Sor Topoisomerase II, intercalation 9.3 vs 10.5 NCT Lack of efficacy and toxicity Lenvatinib VEGFR2, VEGFR3, RET Ongoing NCT Nivolumab PD-1 Ongoing NCT

10 Phase III Second-line Targeted Drug Trials for HCC Agent Target OS vs PBO Mos Trial Number Everolimus mtor 7.6 vs 7.3 NCT Brivanib VEGFR, FGFR 9.4 vs 8.2 NCT Ramucirumab VEGFR2 9.2 vs 7.6 NCT ADI PEG 20 Arginine 7.8 vs 7.4 NCT Regorafenib VEGFR, RET, PDGFR, FGFR, BRAF NCT Cabozantinib c-met Ongoing NCT Ramucirumab VEGFR2 Ongoing AFP > 400 NCT Tivantinib c-met, tubulin Ongoing NCT Apatinib VEGFR2 Ongoing NCT Nivolumab PD-1 Ongoing NCT

11 Reasons for failure of I/II line Phase III Studies Liver toxicity Liver cirrhosis underlies HCC in most of cases, and drugs that can be effective in patients without cirrhosis might induce liver toxicity in patients with this condition (such as sunitinib and linifanib); Lack of substantial antitumoral potency Suboptimal understanding of oncogenic drivers and molecular subclasses in HCC All drugs showed suboptimal antitumoural efficacy to demonstrate survival advantage when all comer populations were included Llovet JM et al. Clin Cancer Res 2014

12 Safety Summary of First line Systemic therapy Phase III trials following approval of Sorafenib Courtesly from Cabibbo G

13 Sunitinib vs Sorafenib in Advanced HCC: Results of a Randomized Phase III Trial Cheng AL et al, J Clin Oncol 2013

14 Reasons for failure of I/II line Phase III Studies Liver toxicity Liver cirrhosis underlies HCC in most of cases, and drugs that can be effective in patients without cirrhosis might induce liver toxicity in patients with this condition (such as sunitinib and linifanib); Lack of substantial antitumoral potency Suboptimal understanding of oncogenic drivers and molecular subclasses in HCC All drugs showed suboptimal antitumoural efficacy to demonstrate survival advantage when all comer populations were included Llovet JM et al. Clin Cancer Res 2014

15 Molecular Targeted Therapies for HCC Their Target Signalling Pathways Brivanib Linifanib Sunitinib Lenvantinib Modified form: Llovet JM et al, Nat Rev Clin Oncol 2015

16 Phase III study of II line ADI-peg 20 vs placebo in patients with advanced HCC ADI PEG 20 Phase II study in advanced HCC ADI PEG 20 Phase II study in advanced HCC Median OS 7.3 ( ) months Post Sorafenib Survival in patients eligible in II Line Trials Yang TS et al, Br J Cancer 2010; Abou-Alfa G et al, 2016 ASCO Annual Meeting;Iavarone M Cabibbo G et al, Hepatology 2015

17 Reasons for failure of I/II line Phase III Studies Liver toxicity Liver cirrhosis underlies HCC in most of cases, and drugs that can be effective in patients without cirrhosis might induce liver toxicity in patients with this condition (such as sunitinib and linifanib); Lack of substantial antitumoral potency Suboptimal understanding of oncogenic drivers and molecular subclasses in HCC All drugs showed suboptimal antitumoural efficacy to demonstrate survival advantage when all comer populations were included Llovet JM et al. Clin Cancer Res 2014

18 Post-progression Survival of Patients with adv. HCC: Rationale for Second Line Trail Design Reig M et al, Hepatology. 2013

19 Reason of Sorafenib Discontinuation in Patients with HCC Rationale for Second Line Trail Design Iavarone M and Cabibbo G et al, Hepatology 2015

20 Molecular Targeted Therapies for HCC Their Target Signalling Pathways Brivanib Linifanib Sunitinib Lenvantinib Modified form: Llovet JM et al, Nat Rev Clin Oncol 2015

21 Phase III RESORCE: Regorafenib in HCC After Progression on Sorafenib Randomized, double-blind phase III trial Randomized 2:1 4-wk cycles Pts with BCLC stage B or C HCC; documented PD on sorafenib 20 days at 400 mg/day; Child-Pugh A liver function; ECOG PS 0-1 (N = 573) Regorafenib + BSC 160 mg PO daily Wks 1-3 (n = 379) Placebo + BSC PO daily Wks 1-3 (n = 194) All pts treated until PD, death, or unacceptable toxicity Primary endpoint: OS (ITT) Secondary endpoints: PFS, TTP, RR, DCR Bruix J, et al. ESMO GI Abstract LBA-03.

22 RESORCE Efficacy of Regorafenib vs Placebo Endpoint Regorafenib (n = 379) Placebo (n = 194) Median OS, mos Median PFS, mos Median TTP 3.2* 1.5* ORR, % *HR 0.44; 95% CI: ; P <.001; P = % reduction in risk of death (HR: 0.62; 95% CI: ; p <.001) 54% reduction in risk of progression or death (HR: 0.46; 95% CI: ; p<.001) DCR (CR + PR + SD): 65.2% vs 36.1% (p<.001) Bruix J, et al. ESMO GI Abstract LBA-03.

23 RESORCE Safety of Regorafenib vs Placebo Adverse Events, % Regorafenib (n = 379) Placebo (n = 194) Any grade 3 AE Hypertension Hand-foot skin reaction Fatigue Diarrhea Dose modifications due to AEs Deaths occurring 30 days after last dose Bruix J, et al. ESMO GI Abstract LBA-03.

24 Molecular Targeted Therapies for HCC Their Target Signalling Pathways Brivanib Linifanib Sunitinib Lenvantinib Modified form: Llovet JM et al, Nat Rev Clin Oncol 2015

25 Tivantinib for second line treatment of adv. HCC gene-expression driven therapy? Phase II study K-M estimates of Overall Survival in the Intention-to-treat population K-M estimates of Overall Survival in the MET-high subgroup Santoro A et al Lancet Oncol 2013

26 Tivantinib Phase 3 Study Design in Patients with MET-High Hepatocellular carcinoma Rimassa L et al, 2016 Gastrointestinal Cancer Symposium Abstr #197

27 MET status in HCC tissue samples after Sorafenib Rimassa L et al, 2016 Gastrointestinal Cancer Symposium Abstr #197

28 Molecular Targeted Therapies for HCC Their Target Signalling Pathways Brivanib Linifanib Sunitinib Lenvantinib Modified form: Llovet JM et al, Nat Rev Clin Oncol 2015

29 Zhu AX et al, Lancet Oncol Ramucirumab in adv. II line HCC ITT OS and AFP>400ng/mL OS

30 Phase 3 Study of Ramucirumab in Second-Line for Patients with HCC and Elevated Baseline AFP (REACH-2) Zhu AX et al, 2016 ESMO on Gastrointestinal Cancer

31 Molecular Targeted Therapies for HCC Their Target Signalling Pathways Brivanib Linifanib Sunitinib Lenvantinib Modified form: Llovet JM et al, Nat Rev Clin Oncol 2015

32 Phase 2 Study of Galunisertib in Second Line in patients with advacend HCC Study design Faifre JS, et al ASCO Annual Meeting [J Clin Oncol J 34, 2016 (suppl; abstr 4070)]

33 Phase 2 Study of Galunisertib in Second Line in patients with advacend HCC TGFb1 responders TGFb1 non responders TGFβ1 rsponders median OS 21.8 months TGFβ1 non-resonders median OS 7.91 months (Log Rank p = 0.002). TGFβ1 responders= patients who decreased serum TGFβ1 > 20% (occurred in 74% of patients). Faifre JS, et al ASCO Annual Meeting [J Clin Oncol J 34, 2016 (suppl; abstr 4070)]

34 Immune Check-point Inibition by Nivolumab Modified from: Topalian SL et aal, N Engl J Med 2012.

35 Study Design of the CheckMate-040 Dose Escalation Study in Advanced HCC El-Khoueiry AB, et al ASCO Annual Meeting [J Clin Oncol 34, 2016 (suppl; abstr 4012)]

36 Interim Analysis of the CheckMate-040 Dose Escalation Study in Advanced HCC El-Khoueiry AB, et al ASCO Annual Meeting [J Clin Oncol 34, 2016 (suppl; abstr 4012)]

37 New agents and new targets in HCC Potential new strategies Tepotinib, Tivantinib???

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