Slide 1: Results from the Fourth Interim Analysis of ARC-7
RESULTS FROM THE FOURTH INTERIM ANALYSIS OF ARC-7 December 20, 2022
Slide 2: Speakers on Today's Call
Speakers on Today’s Call Terry Rosen, Ph.D. | Chief Executive Officer, Arcus Biosciences Dimitry S.A. Nuyten, M.D., Ph.D. | Chief Medical Officer, Arcus Biosciences Jennifer Jarrett | Chief Operating Officer, Arcus Biosciences William Grossman, M.D., Ph.D. | Senior Vice President, Oncology Clinical
Slide 3: Forward Looking Statements
Forward Looking Statements Arcus Forward Looking Statements This presentation contains forward-looking statements. All statements regarding events or results to occur in the future contained herein, including, but not limited to, statements regarding: our strategy, advantages, and expectations, incl
Slide 4: Results from the Fourth Interim Analysis of ARC-7
RESULTS FROM THE FOURTH INTERIM ANALYSIS OF ARC-7 December 20, 2022
Slide 5: Overview of Gilead and Arcus Partnership
Overview of Gilead and Arcus Partnership COLLABORATION SUMMARY COLLABORATION BENEFITS • Gilead currently has rights to five Arcus clinical-stage candidates through its exercised options: Well-funded with $1.3 billion to date – domvanalimab: Fc-silent anti-TIGIT antibody – zimberelimab: anti-PD-1 ant
Slide 6: Anti-TIGIT Mechanism of Action: domvanalimab (dom)
Anti-TIGIT Mechanism of Action: domvanalimab (dom) IMMUNOSUPPRESSION IMMUNE CELL ACTIVATION & TUMOR CELL KILLING T or NK cell T or NK cell PD-1 TIGIT TIGIT Zimberelimab PD-1 CD226 Cytotoxic CD226 proteins PD-L1 released CD155 Domvanalimab PD-L1 CD155 Tumor cell Tumor cell T or NK cell Tumor cell Tum
Slide 7: Key Highlights from ARC-7 IA4
Key Highlights from ARC-7 IA4 • Largest and first prospective randomized SELECT PFS TAKEAWAYS: dataset to date for an anti-TIGIT combination • With median follow-up of 12 months, mPFS was 12.0 in 1L PD-L1-high NSCLC months for the doublet and 10.9 months for triplet • Both dom-containing arms demons
Slide 8: ARC-7: Randomized, Open-label, Ph2 Study in First-Line, Metastatic, PD-L1-High NSCLC
ARC-7: Randomized, Open-label, Ph2 Study in First-Line, Metastatic, PD-L1-High NSCLC ARM 1 Stage IV NSCLC Zim (Z) CO-PRIMARY KEY ELIGIBILITY: 360 mg IV Q3W ENDPOINTS Crossover • Investigator-assessed ORR • Treatment-naïve for to EDZ ARM 2 & PFS per RECIST v1.1 metastatic disease R • PD-L1 ≥50%, loca
Slide 9: Study Populations
Study Populations Population, n (%) Arm 1 (Z) Arm 2 (DZ) Arm 3 (EDZ) Total Intent-to-treat (ITT) 50 50* 50 150 Safety-Evaluable 50 (100) 49 (98) 50 (100) 149 (99) ITT-13 44 (88) 44 (88)* 45 (90) 133 (89) Ongoing first-line treatment 14 (28) 25 (50) 24 (48) 63 (42) ITT: all participants who are rando
Slide 10: Baseline Characteristics
Baseline Characteristics Arm 1 (Z) Arm 2 (DZ) Arm 3 (EDZ) ITT, n (%) (n=50) (n=50) (n=50) Median Age, years (range) 66 (43, 84) 69 (45, 92) 69 (49, 83) > 65 years 28 (56) 34 (68) 35 (70) Sex*: Male 34 (68) 33 (66) 34 (68) Asian 25 (50) 23 (46) 27 (54) Race White 20 (40) 24 (48) 21 (42) Never Smokers
Slide 11: Confirmed Objective Response Rate (cORR): RECIST v1.1 – ITT-13
Confirmed Objective Response Rate (cORR): RECIST v1.1 – ITT-13 Arm 1 (Z) Arm 2 (DZ) Arm 3 (EDZ) ITT-13, n (%) (n=44) (n=44) (n=45) ORR, Confirmed 12 (27) 18 (41) 18 (40) [95% CI] [15.0, 42.8] [26.3, 56.8] [25.7, 55.7] Complete Response 0 (0) 0 (0) 0 (0) Partial Response 12 (27) 18 (41) 18 (40) Stabl
Slide 12: Progression-Free Survival – ITT-13
Progression-Free Survival – ITT-13 Note: Median follow-up of 12 months 12 12
Slide 13: Progression-Free Survival – ITT-13
Progression-Free Survival – ITT-13 CITYSCAPE Tira + Atezo 6mo PFS: ~65%* 6-mo PFS DZ: 65% EDZ: 63% 6-mo PFS CITYSCAPE Z: 43% Placebo + Atezo 6mo PFS: ~30%* Note: Median follow-up of 12 months Mos: Months; HR: Hazard Ratio; CI: Confidence Interval 13 *Cho et al. Lancet 2022
Slide 14: Swimlane – ITT-13 Population
Swimlane – ITT-13 Population • Thirty-one patients with partial response [Arm 1 (n=5), Arm 2 (n=13), Arm 3 (n=13)] and 14 patients with stable disease [Arm 1 (n=3), Arm 2 (n=6), Arm 3 (n=5)] remain on treatment. • Time to initial response ranged from 1.2 – 14.6 months across all arms • Median durati
Slide 15: Overall Safety Profile
Overall Safety Profile Arm 1 (Z) Arm 2 (DZ) Arm 3 (EDZ) Safety evaluable population, n (%) (n=50) (n=49) (n=50) Any TEAEs 50 (100) 47 (96) 48 (96) Grade ≥3 TEAE 29 (58) 23 (47) 26 (52) Grade 5, Related to Study Treatment* 1 (2) 1 (2) 2 (4) Serious TEAE 27 (54) 16 (33) 26 (52) TEAEs leading to study
Slide 16: Immune-related TEAEs (≥ 10% Overall)
Immune-related TEAEs (≥ 10% Overall) Arm 1 (Z) Arm 2 (DZ) Arm 3 (EDZ) Safety evaluable population, n (%) (n=50) (n=49) (n=50) Any Immune-related TEAE* 24 (48) 23 (47) 30 (60) Pneumonitis 7 (14) 4 (8) 5 (10) Grade ≥3 3 (6) 1 (2) 2 (4) Pruritus 8 (16) 3 (6) 5 (10) Rash 6 (12) 5 (10) 9 (18) *Designatio
Slide 17: Building a Potential Best-in-Class TIGIT + PD1 Combination
Building a Potential Best-in-Class TIGIT + PD1 Combination DOM’S BEST-IN-CLASS POTENTIAL Both the doublet and triplet combinations demonstrated clinically meaningful improvements 1 across efficacy measures compared to zim monotherapy Low rates of infusion-related reactions observed across both dom-c
Slide 18: Key Highlights from ARC-7 IA4
Key Highlights from ARC-7 IA4 • Largest and first prospective randomized SELECT PFS TAKEAWAYS: dataset to date for an anti-TIGIT combination • With median follow-up of 12 months, mPFS was 12.0 in 1L PD-L1-high NSCLC months for the doublet and 10.9 months for triplet • Both dom-containing arms demons
Slide 19: Gilead and Arcus Collaboration Includes Four Ph3 and Multiple Platform Ph2 Studies
Gilead and Arcus Collaboration Includes Four Ph3 and Multiple Platform Ph2 Studies The goal is for dom+zim combination to be an IO backbone for novel and transformative combinations in the future PHASE 1/1b PHASE 2 PHASE 3 1L / 2L Upper GI Malignancies (ARC-21) 1L NSCLC, PD-L1 ≥50% (ARC-10) dom + zi
Slide 20: Q&A Session
Q&A Session
Slide 21: Crossover Treatment – EDZ
21 Crossover Treatment – EDZ Crossover (EDZ) Crossover, n (%) (N=12) Confirmed ORR, [95% CI]* 2 (17) [2.1, 48.4] Complete Response 0 (0) Partial Response 2 (17) Stable Disease 8 (67) Progressive Disease 1 (8) Not evaluable 1 (8) Disease Control Rate, [95% CI] 33% [9.9, 65.1] Disease control rate: CR