Tivantinib Overview April 2016
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1 Tivantinib Overview April 2016
2 Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to clinical trials with the Company s product candidates, including tivantinib (ARQ 197), ARQ 092, ARQ 087, ARQ 761, ARQ 751 and ARQ 531, competitive products, financial operations and results, corporate partnerships and other future business objectives, opportunities and strategies. Forward-looking statements are typically identified by words such as believe, expect, anticipate, intend, outlook, position and similar expressions, or future or conditional verbs such as will, should, would, and could. Forward-looking statements are subject to numerous assumptions, risks and uncertainties. Forward-looking statements speak only as of today, and ArQule assumes no obligation to update them. Actual results may differ materially from forward-looking statements or historical performance due to the factors discussed in this presentation and factors previously disclosed in ArQule s SEC reports. See discussion of Risk Factors in the Company s Annual Report on Form 10-K as filed with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. ArQule s product candidates are in various stages of development and are not available for sale or use outside of approved clinical trials. ArQule and the ArQule logo are registered trademarks of ArQule, Inc. 2
3 Pipeline of Products Tivantinib C-MET ARQ 087 FGFR ARQ 092 AKT ARQ 751 AKT ARQ 761 NQO1 ARQ 531 BTK Pre-Clinical Phase 1a/1b Phase 2 Phase 3 Collaborator METIV-HCC Trial (West) Fully Enrolled JET-HCC Trial (Japan) Intrahepatic Cholangiocarcinoma (icca) Solid Tumors Solid tumors/endometrial/ lymphoma cancer - Fully Enrolled Proteus syndrome Other Rare Diseases Cancer/ Rare Diseases Solid Tumors/Pancreatic Cancer Cancer Regulatory Designation SPA Orphan Drug Designation Orphan Drug Designation Orphan Drug Designation 3
4 Tivantinib in HCC Snapshot Tivantinib is a class leading investigational oral inhibitor of the MET receptor tyrosine kinase currently in phase 3 clinical development in two biomarkerdefined trials for second-line treatment of hepatocellular carcinoma (HCC) in a MET-high population METIV-HCC trial being conducted in the West (U.S., Europe, South America, and rest of world), partnered with and co-funded with Daiichi Sankyo¹; this trial is fully accrued JET-HCC trial being conducted in Asia (Japan and select Asian countries), partnered with and funded by Kyowa Hakko² Previous studies support drug activity in MET-high patients In NSCLC (non-small cell lung cancer) a pre-defined sub-analysis from phase 3 trial, MARQUEE In HCC (hepatocellular carcinoma) a successful randomized double blind phase 2 trial In CRC (colorectal cancer) Stage 1 data from a phase 2 investigator-initiated trial In HCC, phase 3 METIV-HCC trial preliminary analysis of baseline MET status Granted Orphan Drug Status for HCC by the FDA and EMA Composition of Matter patent protection through 2030 (U.S.) ¹ Development and Commercialization partnership with Daiichi Sankyo for U.S., Europe, South America, and rest of world. ² Development and Commercialization partnership with Kyowa Hakko for Japan, and select Asian countries. 4
5 Tivantinib Milestones in HCC Phase 1 EXPLORATORY December 2008 Trial initiated January 2010 Preliminary trial results presented at ASCO GI October 2010 Final trial results presented at ESMO Phase 2 PROOF OF CONCEPT September 2010 January 2012 June 2012 January 2013 Trial initiated Trial meet primary endpoints Trial results presented at ASCO Trial results published in Lancet Phase 3 REGISTRATION January 2013 METIV-HCC (second-line HCC) initiated September 2013 Dosage change implemented November 2015 Exercised co-commercialization option in U.S. with Daiichi Sankyo December 2015 Completed accrual March 2016 Completed planned interim analysis trial to continue 5
6 Liver Cancer Facts 782,000 cases diagnosed annually 6 th most common cancer worldwide Liver Cancer A Worldwide Disease 746,000 deaths annually 2 nd most common cause of cancer related death About 90% of all liver cancers are HCC Most cases diagnosed >75 years old Risks include age, cirrhosis, hepatitis A and B and smoking Five Year Survival Rate is 12% Early stages generally do not show symptoms Source: World Cancer Research Fund International/American Institute for Cancer Research. Continuous Update Project Report: Diet, Nutrition, Physical Activity and Liver Cancer Available at: wcrf.org/sites/default/files/liver-cancer-2015-report.pdf 6
7 About Liver Cancer Liver cancer is the abnormal and uncontrolled growth of cells within the liver that disrupt normal liver function. It is typically defined as either primary liver cancer, which starts in the liver, or secondary liver cancer, and spreads to the liver from another part of the body such as the pancreas, colon, stomach, breast or lung. There are four types of primary liver cancer: 1. Hepatocellular carcinoma (HCC): The most common type of liver cancer, HCC starts in the hepatocyte cells of the liver and can have different growth patterns. It can start as a single tumor that grows larger, and only late in the disease does it spread to other parts of the liver. Other times, it can start as many small cancer nodules throughout the liver, which is usually seen in people with cirrhosis. 2. Intrahepatic cholangiocarcinoma (icca): This type of liver cancer (bile duct cancer) starts in the bile ducts (the tubes that carry bile to the gallbladder) within the liver. 3. Angiosarcoma and hemagiosarcoma: These are rare types that start in the blood vessels of the liver. 4. Hepatoblastoma: A very rare type of cancer that develops in children under four years of age. 7
8 HCC High Unmet Need Limited Treatment Options for HCC Current treatment options¹ Surgery Tumor ablation Embolization therapy Radiation treatment Targeted therapy 1 st line therapy - sorafenib is the only approved systemic agent Need for 2 nd line therapy No standard of care exists at this time for 2 nd line therapy Several phase 3 studies in 2 nd line HCC failed brivanib, everolimus, and ramucirumab Tivantinib is the only drug in a biomarker-driven phase 3 trial for HCC ¹ American Cancer Society. Liver Cancer Overview. 8
9 The Role of MET in HCC Amplification and overexpression of the MET pathway is associated with poor outcomes in many cancers, including HCC In cancer cells, MET is dysregulated continuously thus playing a role in cancer cell growth, survival, angiogenesis, invasion and metastasis HGF/MET signaling plays a role in liver regeneration [1] and MET expression is reported to be increased in some HCC tumors [2-4] MET overexpression by IHC correlates with poor prognostic features and poor outcomes [6-8] HGF overexpression and subsequent autocrine MET activation can induce tumor growth in transgenic in vivo models [5] Elevated plasma HGF associated with decreased benefit from sorafenib in SHARP study [9] 1. Borowiak M, et al. Proc Natl Acad Sci U S A. 2004;101: Kiss A, et al. Clin Cancer Res. 1997;3: Selden C, et al. J Hepatol. 1994;21: Tavian D, et al. Int J Cancer. 2000;87: Horiguchi N, et al. Oncogene. 2002;21: Ueki T, et al. Hepatology. 1997;25: Wu FS, et al. Chin J Surg. 2006;44: Santoro A, et al. Lancet Oncol. 2013;14: Llovet JM, et al. Clin Cancer Res. 2012;18:
10 Phase 2 HCC MET Data Tivantinib for second-line treatment of advanced hepatocellular carcinoma: a randomised, placebo-controlled phase 2 study Volume 14, Issue 1, Pages 55-63, January 2013 MET-high Patients Placebo controlled, double blind in patients with advanced HCC and Child-Pugh cirrhosis who progressed or were unable to tolerate first-line systemic therapy 2:1 randomization to receive tivantinib or placebo until disease progression; 37 MET-high patients In the MET-high sub group, median time to progression (TTP) was 2.7 months (95% CI ) in the tivantinib group compared with 1.4 months (95% CI ) in the placebo group (HR 0.43, 95% CI ; p=0.03) Median overall survival was 7.2 months (95% CI ) for patients with MET-high tumours who received tivantinib versus 3.8 months (95% CI ) for patients who received placebo (HR 0.38, 95% CI ; p=0.01) 10
11 Tumor H-Score Tumor H-Score METIV-HCC vs. Phase 2 Baseline Phase 2 HCC Baseline Tumor MET Status 1 Phase 3 METIV-HCC Preliminary Baseline Tumor MET Status* 1 H-Score Median Min Max MET-High Patients MET-Low Patients * Data are preliminary, from non-cleaned database, from biopsied patients regardless of enrollment status ¹ Rimassa, L. et al Gastrointestinal Cancers Symposium. Abstr #197. H-Score Median Min Max MET-High Patients MET-Low Patients Similar patient tumor MET-high population for phase 2 trial and phase 3 METIV-HCC trial 11
12 MET Status After Sorafenib Phase 2 HCC Baseline Tumor MET Status 1 MET-High Samples (rate) Tested samples (N=77) 37 (48%) Phase 3 METIV-HCC Preliminary Baseline tumor MET Status* 1 MET-High Samples (rate) Tested samples (N=1138) 576 (51%) Samples with available biopsy data (N=72) 36 (50%) Samples with available biopsy date (N=925) 527 (57%) Tumor samples taken before sorafenib (N=55) 22 (40%) Tumor samples taken before sorafenib (N=438) 173 (39%) Tumor samples taken after sorafenib (N=17) 14 (82%) Tumor samples taken after sorafenib (N=487) 354 (73%) In both the phase 2 trial and the phase 3 METIV-HCC trials the rate of tumor MET-high patients was higher after sorafenib treatment * Data are preliminary, from non-cleaned database, from biopsied patients regardless of enrollment status ¹ Rimassa, L. et al Gastrointestinal Cancers Symposium. Abstr #
13 Phase 3 MARQUEE MET Data MET-High NSCLC Phase 3 trial of 1,048 patients, selected by non-squamous cell histology previously receiving one to two systemic treatments, tivantinib in combination with erlotinib versus erlotinib plus placebo Trial was discontinued for futility at planned interim analysis in Q In the intent to treat (ITT) population overall survival (8.5 vs 7.8 months, HR = 0.98, 95% CI = 0.84;1.15) improved but was not significant while improvement in progression free survival (3.6 vs 1.9 months, HR = 0.74, CI 0.64;0.85) demonstrated significance Approximately 500 patients were able to be analyzed for MET status per protocol; of these, 211 patients where confirmed as being MET-high of which 104 and 107 patients, respectively, where enrolled in the tivantinib and the placebo arms of the trial¹. A pre-specified exploratory analysis indicated improved median overall survival (9.3 vs 5.9 months, HR = 0.70, 95% CI = 0.49;1.01) and progression-free survival (3.7 vs 1.9 months, HR = 0.72, 95% CI = 0.52;0.98) in patients with high MET expression¹ ¹ Scagliotti, G. et al. ESMO
14 Phase 2 CRC MET Data Progression Free Survival Months Overall Survival Months Investigator-initiated (two stage) Phase 2 single-arm study evaluating tivantinib in combination with cextuximab in EGFR-inhibitor resistant, MET-high, KRAS wild-type colorectal cancer patients failing at least one systemic therapy 21 patients enrolled in Stage 1 with the primary end point of overall survival Stage 1 results 1 patient experienced a complete response (CR) 2 patients experienced durable confirmed partial responses (PRs) Stable disease was observed in 8 patients, including 2 short duration PRs, for an overall Disease Control Rate of (CR + PR + SD) 52.4% The trial has continued to Stage 2 and is expected to be completed by year-end 2015 ¹ Rimassa, L. et al. ESMO 17 th Annual World Congress on Gastrointestinal Cancer Abstr #O-DD8. 14
15 Tivantinib Phase 3 Trial Design METIV-HCC (West)¹ (NCT ) MET-high patients receiving tivantinib in advanced HCC Patients with MET-high (assessed by IHC) inoperable locally advanced metastatic HCC treated with 1 prior systemic therapy (sorafenib) Companion diagnostic Conducted under FDA SPA Stratification Factors Vascular invasion Extra-hepatic spread AFP (< or > 200 ng/ml) Endpoints 1 o : OS Tivantinib 120 mg tablet BID* 2 : PFS, safety ~200 pts Placebo ~100 pts 3 : ORR, DCR, TTP, PD, PK, biomarkers *Dose reduced from 240 mg tablet twice daily (BID) to 120 mg tablet BID following observation of higher incidence of neutropenia. DMC safety analysis of reduced dose cleared the trial to proceed. PK analysis of DMC-determined cohort demonstrated that 120 mg tablet BID has comparable exposure to 240 mg capsule as per the Phase 2 trial data. R A N D O M I Z E D ¹ Development and Commercialization partnership with Daiichi Sankyo for U.S., Europe, South America, and rest of world. 15
16 Tivantinib Financials Daiichi Sankyo Partnership¹ Costs of development are shared 50/50; however, Daiichi is responsible for all phase 3 costs and ArQule reimburses only if milestones and royalties are realized ArQule has received a total of $100 million in upfront and milestone payments from Daiichi and currently owes $59 million for its share of the phase 3 trial Potential for up to an additional approximated $500 million in development and sales milestones Upon commercialization, ArQule will receive tiered, double-digit royalties, starting at 20%, on net sales of tivantinib and has a co-commercialization option in the U.S. Daiichi pays all costs of commercialization, including costs of an ArQule salesforce Kyowa Hakko Kirin Partnership² All development and commercial costs are borne by KHK ArQule has received a total of $48 million in upfront and milestone payments from KHK Potential for up to an additional $75 million in regulatory milestones plus undisclosed sales milestones Upon commercialization, ArQule will receive tiered royalties in the mid-teen to low-twenty percent range on net sales of tivantinib ¹ Development and Commercialization partnership with Daiichi Sankyo for U.S., Europe, South America, and rest of world. ² Development and Commercialization partnership with Kyowa Hakko for Japan, and select Asian countries. 16
17 METIV-HCC Interim Analysis Trial Design Primary Endpoint Overall Survival (OS) > 257 events required Median OS assumptions 7.7 months in treatment arm 5.0 months in placebo arm Hazard ratio = 0.65 Interim Analysis Triggered with ~ 154 OS events DMC was to review and determine: Efficacy stop Continue trial No planned futility stop Minimal alpha spend Analysis occurred March 2016 Trial to run to completion Expect METIV-HCC trial to complete by year-end
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