Study 202 Overall Results and Stage 2 Results
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1 Study 202 Overall Results and Stage 2 Results January 5, 2017 Copyright 2017 Halozyme, Inc. 1
2 Study 202 Design Overview Phase 2, randomized, multicenter study Patients with stage IV (metastatic), previously untreated PDA Primary & Secondary PFS Endpoint: 80% power at 2-sided alpha level of 0.1 CR, complete response; DCR, disease control rate; DoR, duration of response; HA, hyaluronan; KPS, Karnofsky performance status; ORR, objective response rate; OS, overall survival; PDA, pancreatic ductal adenocarcinoma; PFS, progression-free survival; PR, partial response; SD, stable disease. 2
3 Halozyme/Ventana HA Companion Diagnostic (CDx) Determining HA Status Novel CDx to identify patients with HA-High PDA tumors An affinity histochemistry assay with a scoring algorithm based on the HA staining pattern area in the extracellular matrix (ECM) over the entire tumor surface PDA tumors are HA-High when the HA score is 50% 3
4 Study 202 Study Timeline Mar April Aug Feb Dec Enrollment Training Set for CDx Stage 1: n=146 Clinical Hold Protocol Amendment Hold Lifted Enrollment Follow up Data Readout Validation Set for CDx Stage 2: n=133 Develop Ventana HA scoring algorithm and cut-point ~40% HA High patients treated on P arm discontinued PEGPH20 at the clinical hold Prospectively validate Ventana HA scoring algorithm and cut-point used in Phase 3 study To be presented at Scientific Forum 2017 Presented at ASCO
5 Study 202: Modifications Since Stage 1 Clinical Hold Statistical Analysis Plan Planned Analysis Populations: - Intent-to-Treat: Combined Stage 1 + Stage 2 efficacy analyses - Efficacy Evaluable (requires post baseline assessment): Primary endpoint (PFS) - Treated population: Separate analyses of Stage 1 and Stage 2 PFS event definition to include deaths occurring within 14 days of last study treatment Protocol Added Stage 2 Cohort: - 2:1 P to randomization - Excluded high TE risk patients - Added Low Molecular Weight Heparin prophylaxis to both arms - Added primary endpoint: rate of TE events in P patients 5
6 Study 202 Study Populations: December 2016 Population Stage 1 (n) Stage 2 (n) Total Phase 2 (Stage 1 & Stage 2) (n) Intent-To-Treat (Total) Intent-to-Treat (HA High) HA-High: 47 HA-High: 37 HA-High: 84 (PFS Secondary Endpoint) Treated Population (Total) Treated Population (HA High) HA-High: 45* HA-High: 35 HA-High: 80 Data Maturity: HA High Median Follow-Up Off Treatment Off Study 8.8 months (0.3, 39.8) 100% 98% 8.7 months (0.6, 27.9) 92% 80% 8.5 (0.0, 39.8) 96% 90% *Updated from ASCO 2016 where number of patients was 43 HA High; December Analysis includes 2 additional HA high patients (P arm), 2 PFS events reclassified upon data reconciliation, PFS analysis per revised definition. Updated Stage 1 data: medians unchanged; HR 0.48 (0.18, 1.32) 6
7 Study 202 Efficacy Summary 7
8 Stage 1 Secondary Endpoint PFS and Exploratory Endpoint OS in HA-High Patients Progression Free Survival Overall Survival HR 0.48 (0.18, 1.32) HR 1.37 (0.69, 2.70) 6.0 months P 9.2 months 10.9 months P 11.5 months Treated Population 8
9 Stage 2 Secondary Endpoint PFS and Exploratory Endpoint OS in HA-High Patients Progression Free Survival Overall Survival HR 0.63 (0.21, 1.93) HR 0.52 (0.22, 1.23) 4.5 months P 8.6 months 7.8 months P 11.7 months Treated Population 9
10 Study 202 (Stage 1 + Stage 2) Secondary Endpoint PFS and Exploratory Endpoint OS in HA-High Patients Progression Free Survival Overall Survival HR: 0.51 (0.26, 1.00); P value: HR 0.96 (0.57, 1.61) 5.2 months P 9.2 months 8.5 months P 11.5 months ITT Population 10
11 Stage 2 Data 11
12 Stage 2 Patient Population Populations (n) P Treated Population N=125 Treated with HA available data N=111 Treated (HA High) N=35 (32%) Treated (HA Low) N=76 (68%) Baseline characteristics balanced across all groups 12
13 Stage 2 Secondary Endpoint PFS in HA High Patients In 35 HA high patients, the P arm had a 91% improvement in median PFS over the arm; HR 0.63 Populations Events/Total (n); Median PFS, months P HR (95% CI) All treated 57/86; /39; ( ) All treated with HA data 53/77; /34; ( ) HA-Low 40/53; /23; ( ) HA-High 13/24; 8.6 5/11; ( ) 6-month PFS Rate 68% 30% 12-month PFS Rate 28% 30% Differences in PFS between treatment arms did not reach statistical significance CI, confidence interval; HR, hazard ratio Treated Population 13
14 Stage 2 Secondary Endpoint PFS in HA-High Patients HR: 0.63 (0.21, 1.93) P 8.6 months 4.5 months Remaining on treatment: P (n=2); (n=1) Treated Population 14
15 Stage 2 Exploratory Endpoint Overall Survival in HA-High Patients HR 0.52 (0.22, 1.23) 7.8 months P 11.7 months Remaining on treatment and/or follow up: P (n=6); (n=1) Treated Population 15
16 Stage 2 PFS and OS Results Support HA High As A Potential Predictive and Prognostic Biomarker P HA- High n = 24 PFS: 8.6 months OS: 11.7 months n = 11 PFS: 4.5 months OS: 7.8 months HR = 0.63 HR = 0.52 HA- Low n = 53 PFS: 6.0 months n = 23 PFS: 7.2 months HR = 1.21 OS: 11.9 months OS: 10.2 months HR = 0.69 Treated Population 16
17 Stage 2 Treatment Exposure* Populations, n P Treated population (n=125) Treated population with HA data (n=111) (HA-High/HA-Low) Treated population with HA data duration of treatment, months Median (range) 77 (24/53) 34 (11/23) 5.6 ( ) 3.2 ( ) Treated subjects (HA-High) Duration of treatment, months median (range)* n = ( ) n = ( ) 6 months, n (%) 11 (46) 1 (9) 12 months, n (%) 5 (21) 1 (9) *Exposure: first to last dose of any study medication Treated Population 17
18 Stage 2 Treatment-Related Adverse Events (AEs) in 25% of Patients P (n = 86) Patients, n (%) (n = 39) Patients, n (%) Preferred Term Any Grade Grade 3 Any Grade Grade 3 Any AE 84 (97.7) 74 (86.0) 37 (94.9) 30 (76.9) Fatigue 63 (73.3) 18 (20.9) 24 (61.5) 5 (12.8) Peripheral edema 57 (66.3) 6 ( 7.0) 7 (17.9) 0 ( 0.0) Muscle spasms 48 (55.8) 14 (16.3) 2 ( 5.1) 1 ( 2.6) Alopecia 36 (41.9) 1 ( 1.2) 14 (35.9) 0 ( 0.0) Anemia 36 (41.9) 12 (14.0) 14 (35.9) 10 (25.6) Nausea 36 (41.9) 3 ( 3.5) 16 (41.0) 2 ( 5.1) Diarrhea 33 (38.4) 5 ( 5.8) 15 (38.5) 3 ( 7.7) Decreased appetite 32 (37.2) 3 ( 3.5) 11 (28.2) 0 ( 0.0) Neutropenia 32 (37.2) 28 (32.6) 10 (25.6) 9 (23.1) Neuropathy peripheral 30 (34.9) 6 ( 7.0) 13 (33.3) 3 ( 7.7) Thrombocytopenia 28 (32.6) 16 (18.6) 7 (17.9) 2 ( 5.1) ALT increased 25 (29.1) 16 (18.6) 3 (7.7) 3 (7.7) Dysgeusia 25 (29.1) 0 9 (23.1) 0 Myalgia 23 (26.7) 5 (5.8) 2 (5.1) 0 Platelet Count Decreased 23 (26.7) 5 (5.8) 3 (7.7) 2 (5.1) Vomiting 22 (25.6) 1 (1.2) 11 (28.2) 2 (5.1) 18
19 Stage 2 Select Grade 3+ Laboratory Abnormalities: September 2016 Hematologic Laboratory Abnormalities P n = 86 n (%) n = 39 n (%) Anemia 20 (23) 11 (28) Thrombocytopenia 14 (16) 5 (13) Neutropenia 42 (49) 17 (44) Hepatic Laboratory Abnormalities P n = 86 n (%) n = 39 n (%) ALT increased 13 (15) 3 (8) AST increased 6 (7) 5 (13) Total Bilirubin increased 3 (4) 4 (10) 19
20 Stage 2 Incidence of Thromboembolic (TE) Events Enoxaparin Prophylaxis Dose P TE Rate 43% (32/74) 25% (15/61) Stage 1* (Dec 2016) N/A HA high : 42% (10/24) HA high : 24% (5/21) HA low : 46% (21/46) HA low : 28% (9/32) Stage 2** (Dec 2016) Started with 40 mg/day Started on 1 mg/kg/day 28% (5/18) 10% (7/68) 29% (2/7) 6% (2/32) *Stage 1 data reflects additional biopsies collected: 2 HA-High (2 P); and 3 HA-Low (2 P; 1 ) **TE rates for all stage 2 patients are 14% (12/86) in P arm and 10% (4/39) in arm Treated Population 20
21 Study 202 (Stage 1 and Stage 2 Data) 21
22 Study 202 (Stage 1 + Stage 2): Progression Free Survival Events/Total (n); Median PFS, months Populations P HR (95% CI) P value Efficacy Evaluable 100/139; /92; (0.53, 1.00) Intent-to-Treat 102/166; /113; ( ) Intent-to-Treat with HA data 95/153; /93; ( ) NS HA-Low 71/104; /58; ( ) NS HA-High 24/49; /35; ( ) month PFS Rate 67% 45% 12-month PFS Rate 22% 9% NS, not significant; CI, confidence interval; HR, hazard ratio. ITT Population 22
23 Study 202 (Stage 1 + Stage 2) Secondary Endpoint: PFS in HA-High Patients HR: 0.51 (0.26, 1.00); P value: months P 9.2 months Remaining on treatment: P (n=2); (n=1) ITT Population 23
24 Study 202 (Stage 1 + Stage 2) PFS by HA Cut-point Using Ventana Assay 50% HA High Cutoff Shows Robust Signal HA cutoff level Ventana Assay CombinedStudy 202 Data P arm Events/Patients Median 75% 9/ months 50% 24/ months <50% 71/ months CombinedStudy 202 Data arm Events/Patients Median 10/ months 19/ months 38/ months ITT Population 24
25 Study 202 (Stage 1 + Stage 2) Exploratory Endpoint: Overall Survival in HA High Patients HR: 0.96 (0.57, 1.61) 8.5 months P 11.5 months Remaining on treatment and/or follow up: P (n=6); (n=2) ITT Population 25
26 Study 202 (Stage 1 + Stage 2): Treatment Exposure* Populations, n P Treated Population (n=260) Treated Population with HA data (n=234) (HA-High/HA-Low) (48/99) 87 (32/55) Treated subjects (HA-High) Duration of treatment, months median (range) n = ( ) n = ( ) 6 months, n (%) 19 (40) 3 (9) 12 months, n (%) 6 (13) 1 (3) *Exposure: first to last dose of any study medication Treated Population 26
27 Study 202 (Stage 1 + Stage 2) Treatment-Related Adverse Events (AEs) in 25% of Patients Preferred Term P (n = 160) Patients, n (%) (n = 100) Patients, n (%) Any Grade Grade 3 Any Grade Grade 3 Any AE 157 (98.1) 138 (86.3) 93 (93.0) 75 (75.0) Fatigue 115 (71.9) 33 (20.6) 66 (66.0) 16 (16.0) Peripheral edema 101 (63.1) 8 ( 5.0) 26 (26.0) 4 ( 4.0) Muscle spasms 89 (55.6) 20 (12.5) 3 ( 3.0) 1 ( 1.0) Nausea 79 (49.4) 8 ( 5.0) 47 (47.0) 4 ( 4.0) Diarrhea 64 (40.0) 11 ( 6.9) 39 (39.0) 5 ( 5.0) Anemia 62 (38.8) 27 (16.9) 38 (38.0) 20 (20.0) Alopecia 60 (37.5) 1 ( 0.6) 39 (39.0) 0 ( 0.0) Decreased appetite 59 (36.9) 7 ( 4.4) 25 (25.0) 2 ( 2.0) Neutropenia 54 (33.8) 47 (29.4) 19 (19.0) 18 (18.0) Neuropathy peripheral 47 (29.4) 10 ( 6.3) 31 (31.0) 8 ( 8.0) Vomiting 46 (28.8) 5 ( 3.1) 27 (27.0) 2 ( 2.0) Dysgeusia 45 (28.1) 0 19 (19.0) 0 Myalgia 41 (25.6) 8 ( 5.0) 7 ( 7.0) 0 ( 0.0) Thrombocytopenia 41 (25.6) 26 (16.3) 17 (17.0) 9 ( 9.0) Treated Population 27
28 Summary & Conclusions 28
29 Study 202: Consistent Improvement in PFS in PEGPH20 Treatment Arm Secondary Endpoint PFS in HA-High Patients Study 202 (Stage 1 & Stage 2) Stage 2 HR:0.51 (0.26, 1.00); P value HR 0.63 (0.21, 1.93) 5.2 months P 9.2 months 4.5 months P 8.6 months 29
30 Stage 2 PFS and OS Results Support HA High As A Potential Predictive and Prognostic Biomarker P HA- High n = 24 PFS: 8.6 months OS: 11.7 months n = 11 PFS: 4.5 months OS: 7.8 months HR = 0.63 HR = 0.52 HA- Low n = 53 PFS: 6.0 months n = 23 PFS: 7.2 months HR = 1.21 OS: 11.9 months OS: 10.2 months HR = 0.69 Treated Population 30
31 Study 202 Conclusions 1. Randomized Phase 2 Study 202 met multiple key study objectives Primary Endpoint (PFS) achieved Secondary Endpoint (PFS in HA High patients) achieved 2. Stage 2 of Study 202 met primary safety endpoint & shows consistent improvement across PFS and OS in HA High patients Primary Safety Endpoint achieved: Decreased TE events with protocol modifications & LMWH prophylaxis Secondary Endpoint: 91% improvement in median PFS Exploratory Endpoint: 50% improvement in median OS HA algorithm and cut-point of 50% validated 3. Randomized Phase 2 Study 202 results continue to support the Phase 3 HALO 301 trial Same patient population as Stage 2 with LMWH prophylaxis Same CDx cutoff as Phase 2 study Two primary endpoints: PFS (Phase 2 statistically significant); and OS (Stage 2 signal) 31
32 Study 202 Overall Results and Stage 2 Results January 5, 2017 Copyright 2017 Halozyme, Inc. 32
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