Preliminary Results from a Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Family (MiT) Associated Tumors

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1 Preliminary Results from a Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transcription Factor Family (MiT) Associated Tumors John Goldberg 1 *, George Demetri 2, Edwin Choy 3, Lee Rosen 4, Alberto Pappo 5, Steven DuBois 6, James Geller 7, Feng Chai 8, Dora Ferrari 8, Andrew Wagner 2 * 1. University of Miami Miller School of Medicine, Miami, FL; 2. Dana Farber Cancer Institute, Boston, MA; 3. Massachusetts General Hospital, Boston, MA; 4. Premiere Oncology, Santa Monica, CA; 5. Texas Children's Cancer Center, Houston TX; 6. University of California San Francisco Medical Center, San Francisco, CA; 7. Cincinnati Children's Hospital Medical Center, Cincinnati, OH ; 8. ArQule, Inc., Woburn, MA * These authors contributed equally to the study

2 Background MiT tumors include clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS) and Xp11.2-translocated renal cell carcinoma (RCC) MiT tumors are associated with dysregulation of a related group of transcription factors with similarity to MITF (microphthalmia transcription factor), including MITF, TFE3 and TFEB

3 Background (cont) These transcription factors are believed to upregulate many oncogenic pathways, including c-met through binding of its promoter These tumors are generally resistant to all conventional therapies and, if unable to be surgically excised, invariably fatal

4 TFE3 Fusions Activate MET Signaling Through Transcriptional Upregulation Tsuda M, Davis IJ, Arqani P, et al. TFE3 Fusions Activate MET Signaling by Transcriptional Upregulation, Defining Another Class of Tumors as Candidates for Therapeutic MET Inhibition. Cancer Res. 2007;67:

5 ARQ 197 Selective, non-atp competitive inhibitor of c-met K i for c-met ~ 350 nm IC 50 s: CAMKII ~ 10 M Flt4 ~ 16 M PAK3 ~ 6.6 M Pim-1 33% 10 M c-met ARQ 197 demonstrates a favorable safety profile and preliminary anti-cancer activity in Phase 1 studies K i or IC 50

6 ARQ 197 Inhibits Phospho-c-MET in CCS292 Cell Line 100 CCS292 cell line IC 50 = 0.2 M CCS292 rhhgf (100 ng/ml): ARQ 197 ( M): Phospho c-met Cell Survival (%) ARQ 197 ( M) GI 50 ~ 200 nm c-met CCS292 cells were seeded in 96-well plates at 5,000 cells/well overnight in medium with 10% FBS. The next day, cells were treated with increasing concentrations of compound for 72 hours at 37 C. After addition of MTS reagents, the results were quantitated by spectrophotometry at = 490 nm and the GI 50 was determined. -actin

7 Study Design Multi-center, single arm, two-stage Phase 2 trial Recommended Phase 2 dose increased during study from 120 mg BID to 360 mg BID

8 Inclusion Criteria Tumor types: CCS, ASPS and TLA RCC Patient age: 13 years Patients with treated CNS metastases eligible if stable for 3 months and no neurologic symptoms No limitation on number of prior therapies Sufficient organ function

9 Methods Oral administration twice daily Continuous dosing over 28-day cycles Dosing initially 120 mg BID, then amended to 360 mg BID 18 patients on 120 mg BID 8 patients escalated from 120 to 360 mg BID 10 patients on 360 mg BID Tumor restaging performed at 8-week intervals, per RECIST criteria

10 Demographics CCS (N=9) ASPS (N=21) RCC* (N=6) Total (N=36) Age Sex ECOG F 4 (44%) 16 (76%) 4 (67%) 24 (67%) M 5 (56%) 5 (24%) 2 (33%) 12 (33%) 0 5 (56%) 11 (52%) 4 (67%) 20 (56%) 1 4 (44%) 10 (48%) 2 (33%) 16 (44%) Prior drug Rx Prior radiation Prior surgery Brain metastasis Yes 0 (0%) 3 (14%) 1 (17%) 4 (11%) No 9 (100%) 18 (86%) 5 (83%) 32 (89%) * In 3 of 6 RCC patients, Xp11.2 translocations (TFE3 gene fusions) were not confirmed.

11 Number and Sites of Lesions at Baseline Median number of lesions at baseline: 5.0 Location of lesions: Lesion location CCS (N=9) ASPS (N=21) RCC* (N=6) Total (N=36) Liver Lung Brain Lymph node Others * In 3 of 6 RCC patients, Xp11.2 translocations (TFE3 gene fusions) were not confirmed.

12 Drug Safety Most common ( 5%) drug-related adverse events (AEs) AE Term No. Patient (%) (N=36) Total Grade 3 Fatigue 15 (42%) 0 Nausea 12 (33%) 0 Vomiting 8 (22%) 0 Cough 4 (11%) 0 Sinus Bradycardia 4 (11%) 0 Diarrhea 3 (8%) 0 Anemia 3 (8%) 2 (6%) Drug-related serious AEs (SAEs) SAE Term Dose (mg BID) Outcome Grade 3 Febrile Neutropenia 360 Resolved within 1 week Grade 4 Thrombocytopenia 360 Resolved within 2 weeks

13 Efficacy 28 patients with available post-baseline tumor assessments (evaluable for efficacy analysis) PR SD PD Disease control rate # ASPS (N=16) 0 (0%) 13 (81%) 3 (19%) 81% CCS (N=7) 1 (14%) 2 (29%) 4 (57%) 43% RCC (N=5)* 0 (0%) 2 (40%) 3 (60%) 40% Total (N=28) 1 (4%) 17 (61%) 10 (36%) 64% # Disease control rate = (PR+SD) / Number of evaluable patients X 100 * In 2 of 5 RCC patients, Xp11.2 translocations (TFE3 gene fusions) were not confirmed

14 CT Scans of Patient 10 with CCS Baseline - April 7, 2008 Cycle 6 - October 6, 2008 (45.3% reduction) 29.4 mm 8.8 mm 18.3 mm 17.3 mm

15 Duration of Drug Exposure Patient ID ASPS CCS RCC* Weeks on Study + Patients currently on study * In 3 of 6 RCC patients (patient 15, 33 and 35), Xp11.2 translocations (TFE3 gene fusions) were not confirmed.

16 Conclusions ARQ 197 has demonstrated a favorable safety profile in both adults and pediatric patients Enrollment at 360 mg BID is ongoing Preliminary evidence of anti-cancer activity observed

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