Arcus Biosciences, Inc. · NYSE:RCUS
Arcus Biosciences — Q3 2024 Earnings Presentation
73 slides from Arcus Biosciences's earnings presentation, Nov 6, 2024
Slide 1: Combining to Cure
® COMBINING TO CURE Arcus is at the forefront of designing combination therapies, with best-in-class potential, in the relentless pursuit of cures for cancer. CORPORATE PRESENTATION Nov. 6, 2024
Slide 2: Forward-looking Statements/Safe Harbor
Forward-looking Statements/Safe Harbor Forward Looking Statements Safe Harbor: This presentation contains forward-looking statements about Arcus Biosciences, Inc. (“we,” “Arcus” or the “Company”) made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All
Slide 3: Late-stage Portfolio of Differentiated Assets, Highly Productive R&D Engine
Arcus Has Created a Late-stage Portfolio of Differentiated Assets, Fueled by a Highly Productive R&D Engine FUNDING INTO POTENTIAL PHASE 3 STUDIES FOR DOM MID-2027 BEST-IN-CLASS HIF-2a IN LUNG & UPPER GI INHIBITOR, CASDATIFAN PROGRESSING TO DATA ~$1.1B in cash, Commercially validated cash equivalent
Slide 4: New Disclosures in Third Quarter 2024 Earnings
New Disclosures in Third Quarter 2024 Earnings • ARC-20 results for the 50mg BID and 50mg QD were presented at EORTC-NCI- AACR; The 50mg BID cohort showed best-in-class potential: • 25% cORR (8/32) / 34% ORR (11/32) ▪ 2 PRs remain on treatment with the potential to confirm Casdatifan ▪ 1 PR will not
Slide 5: ARC-20 Results Support Casdatifan's Potential Best-in-Class Profile
ARC-20 Results Support Casdatifan’s Potential Best-in-Class Profile, Despite Shorter Follow-up MORE SHORTER ADVANCED FOLLOW- COMPARABLE PATIENTS UP IMPROVED EFFICACY PROFILE SAFETY Median Primary ORR / mPFS Gr 3+ Gr 3+ % ≥4 prior LoT months of progressive DCR cORR (months) hypoxia anemia follow-up d
Slide 6: More ARC-20 Data Expected Over Next 12-18 Months
More ARC-20 Data Is Expected Over the Next 12-18 Months EXPECTED TIMING ARC-20 COHORT(S) OUTCOME MEASURES 50mg BID (100mg) and 1Q 2025 More mature ORR & PFS 50mg QD 50mg BID (100mg) and 50mg QD ORR & PFS for all 150mg and 100mg QD monotherapy cohorts 2H 2025 (tablet) cas + cabo Safety Late 2025 / ca
Slide 7: Targeting Huge Market Opportunities and Unmet Need
Targeting Huge Market Opportunities and Unmet Need ADDRESSABLE MARKET PHASE 1/2 STUDIES PHASE 3 STUDY INDICATION PH 3 STUDY DETAILS PATIENTS 1 POTENTIAL2 dom + zim + 1L Gastric/GEJ/EAC 103K ~$3B chemo vs nivo + - all comers mPFS presented at ASCO ‘24 Fully Enrolled 2Q24 chemo dom + zim + DOM + ZIM 1
Slide 8: Our Partnerships Greatly Expand & Accelerate Our Opportunities
Our Partnerships Greatly Expand & Accelerate Our Opportunities 10-YEAR COLLABORATION • Gilead has opted into 5 molecules to date -- shares costs for studies within the joint development plan • Arcus retains U.S. co-commercialization rights COLLABORATION FOR JAPAN AND OTHER TERRITORIES IN ASIA (EX-CH
Slide 9: Casdatifan (HIF-2a) in ccRCC
Casdatifan (HIF-2a) in ccRCC 9 © Arcus Biosciences 20 24
Slide 10: ARC-20 Results Support Casdatifan's Potential Best-in-Class Profile
ARC-20 Results Support Casdatifan’s Potential Best-in-Class Profile Despite Short Follow Up / Advanced Patient Population Potential for Best-in-Class DIFFERENTIATED COMBINATIONS Efficacy with Comparable Safety* Phase 3 cas + cabo vs. cabo in post-IO ccRCC 100mg Daily Expansion Cohort**: • Cabo is th
Slide 11: Cas Has an Optimal PK / PD Profile
Cas Has an Optimal PK / PD Profile Pharmacodynamics Pharmacokinetics 20mg of cas achieves the same EPO Linear, dose-proportional PK and (peripheral PD biomarker) suppression 24-hour half life as that of 120mg of belzutifan Dotted line = EPO% change for belzutifan at 120mg ‡ Cas, 20mg Daily Cas, 100m
Slide 12: Greater and Longer-term Suppression of Erythropoietin
Cas Treatment Also Appears to Result in Greater and Longer-term Suppression of Erythropoietin Belzutifan Casdatifan 100mg Daily Mean percentage change in ccRCC patients in dose escalation + erythropoietin from baseline over time dose expansion erythropoietin (mIU/mL) from baseline 20 Mean (90% CI) p
Slide 13: ARC-20 Phase 1 Dose-Escalation and Dose-Expansion Study of Casdatifan
ARC-20 Is a Phase 1 Dose-Escalation and Dose-Expansion Study of Casdatifan Dose Escalationa Dose Expansion 3+3 design with 21-day DLT window Patients with 2L+ ccRCC Patients with advanced solid-tumors N~30 per cohort 200mg QD PRESENTED: PRIMARY KEY INCLUSION 50mg BID (100mg Daily) v OUTCOMES: CRITER
Slide 14: Key Efficacy Measures Compare Favorably to Benchmark Studies
Key Efficacy Measures All Compare Very Favorably to Contemporary Benchmark Studies Despite Shorter Follow-up Casdatifan 100mg Daily Casdatifan 50mg QD Efficacy Evaluable Population1 (n = 32) (n = 28) 34.4% (11*) 25.0% (7) ORR (n) [90% CI] [18.6%, 53.2%] [10.7, 44.9] Responses pending confirmation, n
Slide 15: Vast Majority of Patients Experienced Tumor Reduction in Both Cohorts
Vast Majority of Patients Experienced Tumor Reduction in Both Cohorts 100mg Daily Cohort 50mg QD Cohort 100 100 80 80 60 60 40 40 20 20 0 0 -20 -20 -40 -40 -60 -60 -80 -80 -100 -100 Best Response Type Complete Response Partial Response Stable Disease Progressive Disease Ongoing • 5 patients* in the
Slide 16: Spider Plots Illustrate Durable Disease Control for Both Doses
Spider Plots Illustrate Durable Disease Control for Both Doses 100mg Daily Cohort 50mg QD Cohort 80 80 Best Percent Change From Baseline in 16 patients remain on Best Percent Change From Baseline in Sum of Target Lesion Diameters, % Sum of Target Lesion Diameters, % 60 treatment, 10 in responses 60
Slide 17: Significant Portion of Patients Remain on Study for Both Cohorts
Significant Portion of Patients Remain on Study for Both Cohorts 100mg Daily Cohort 50mg QD Cohort 16 patients remain on 20 patients remain on treatment, 10 with PRs treatment, 7 with PRs 0 5 10 15 20 25 30 35 40 45 50 55 60 0 5 10 15 20 25 30 35 40 Time on Treatment, Weeks Time on Treatment, Weeks
Slide 18: TEAE Profile is Very Manageable
TEAE Profile is Very Manageable DOSE EXPANSION Safety-evaluable population 100mg Daily 50mg QD (n=31) (n=33) Any TEAEs, n (%) 32 (97) 30 (97) Related to casdatifan 31 (94) 28 (90) Any serious TEAEs, n (%) 4 (12) 7 (23) Related to casdatifan 1 (3) 2 (7) Any Grade 3 TEAEs, n (%) 15 (46) 16 (52) Relate
Slide 19: ARC-20 Results Support Casdatifan's Potential Best-in-Class Profile
ARC-20 Results Support Casdatifan’s Potential Best-in-Class Profile, Despite Limited Follow-up MORE SHORTER ADVANCED FOLLOW- COMPARABLE PATIENTS UP IMPROVED EFFICACY PROFILE SAFETY Median Primary ORR / mPFS Gr 3+ Gr 3+ % ≥4 prior LoT months of progressive DCR cORR (months) hypoxia anemia follow-up d
Slide 20: More ARC-20 Data Is Expected Over the Next 12-18 Months
More ARC-20 Data Is Expected Over the Next 12-18 Months EXPECTED TIMING ARC-20 COHORT(S) OUTCOME MEASURES 50mg BID (100mg) and 50mg 1Q 2025 More mature ORR & PFS QD 50mg BID (100mg) and 50mg QD ORR & PFS for all 150mg and 100mg QD monotherapy cohorts 2H 2025 (tablet) cas + cabo Safety Late 2025 / ca
Slide 21: Cas Development Plan Targets the Largest Market Segments
Cas Development Plan Targets the Largest Market Segments and Could Expand Share Within These Segments 2024 ccRCC • US Market Share 100% 3% 4% 10% 90% 5% chemo 3% 80% 6% belz (+/- other) 12% non-cabo TKI mono 70% 32% Nivo-Ipi % Patient Share 4% avelumab + atixinib 60% lenva + everolimus 50% Cabo mono
Slide 22: The Casdatifan Clinical Program Will Continue to Expand
The Casdatifan Clinical Program Will Continue to Expand CURRENT CAS DEVELOPMENT PROGRAM CAS FUTURE DEVELOPMENT TRIAL GOAL(S) STATUS Phase 1a: Establish safety/ tolerability Completed Other novel ARC-14 in healthy volunteers 56 healthy volunteers dosed with cas combinations Phase 1b: Establish safety
Slide 23: Proposed Phase 3 Study Evaluating Cas + Cabo in ccRCC
Proposed Phase 3 Study Evaluating Cas + Cabo in Advanced or Metastatic ccRCC, following prior PD-1 Tx PATIENT POPULATION: • Unresectable, locally N~700 advanced or metastatic CASDATIFAN + CABOZANTINIB PRIMARY ENDPOINT: ccRCC • PFS • Measurable disease per KEY SECONDARY RECIST 1.1 R ENDPOINTS: 2:1 •
Slide 24: Targeting Substantial Markets with Best-in-Class and First-in-Class Combinations
Arcus is Targeting Substantial Markets with Potential Best- in-Class and First-in-Class Combinations CURRENT SOC FUTURE TREATMENT MARKET SIZE (US)6 DIFFERENTIATION PD-1 mono: HIF-2α + PD-1 Adjuvant - mDFS NR, 4Y DFS ~65%1 belz + pembro 17.5k patients7 PD-1 + CTLA4: HIF-2α + PD-1/CTLA4 ORR 39%, mPFS
Slide 25: Domvanalimab in Non-Small Cell Lung Cancer and Upper GI Cancers
Domvanalimab in Non-Small Cell Lung Cancer and Upper GI Cancers 25 © Arcus Biosciences 20 24
Slide 26: Dom is the Most Clinically Advanced Fc-Silent Anti-TIGIT Antibody
Dom is the Most Clinically Advanced Fc-Silent Anti-TIGIT Antibody in Development TIGIT inhibition turns an immuno-suppressive First-to-Market potential in Upper GI & “brake” into an accelerator of adaptive immunity the only Fc-silent anti-TIGIT in Ph3 NSCLC 1 2 Dom blocks TIGIT, an inhibitory TIGIT
Slide 27: Three De-Risking Phase 2 Datasets for Domvanalimab Plus Zimberelimab
Three De-Risking Phase 2 Datasets Have Been Presented for Domvanalimab Plus Zimberelimab Regimens 1L PD-L1 high NSCLC 1L PD-L1 high NSCLC 1L Gastric/EAC/GEJ dom + zim vs. zim or chemo (n=95) dom + zim + FOLFOX (n=40) dom + zim vs. zim vs. etruma + dom + zim (n=150) • mPFS well beyond historical • PF
Slide 28: Summary of ARC-10 Results and Dom + Zim Program in NSCLC
Summary of ARC-10 Results and Domvanalimab Plus Zimberelimab Clinical Program in Non-Small Cell Lung Cancer Data presented at the 2024 Society for Immunotherapy of Cancer (SITC) ASCO, based on data cut-off of Aug. 30, 2024. 28 © Arcus Biosciences 20 24
Slide 29: Two Datasets Show Consistent Improvement for Dom + Zim in 1L PD-L1 High NSCLC
Two Different Datasets Demonstrate a Very Consistent Improvement for Dom + Zim in 1L PD-L1 High NSCLC 1L PD-L1 high NSCLC dom + zim vs. zim vs. etruma + dom + 1L PD-L1 high NSCLC zim (n=150) dom + zim vs. zim or chemo (n=95) 33% reduction in risk of progression or death (PFS) for DZ vs Z 36% reducti
Slide 30: ARC-10 Part 1: Randomized Trial in PD-L1-High NSCLC
Part 1: Global, Multi-Center, Randomized, Open-Label Trial in Front-Line, PD-L1-High, Stage IIIb-IV NSCLC • At time of protocol development, platinum-doublet chemo was selected as the control arm in countries where anti–PD-(L)1 therapy was not yet the standard of care • Tumor assessments were perfor
Slide 31: PFS and OS Were Greater With Dom + Zim vs Zim
(A) PFS and (B) OS Were Greater With Dom + Zim vs Zim ARC-10 – Johnson et a l. SITC 2024, No v. 5 2 024, d ata cut o ff of May 17, 2024, median follow-up of 24.5 mon ths 31 © Arcus Biosciences 20 24
Slide 32: TRAEs Leading to Discontinuation were Greater with Chemo
Treatment-Related Adverse Events (TRAEs) Leading to Treatment Discontinuation were Greater with Chemo ARC-10 – Johnson et a l. SITC 2024, No v. 5 2 024, d ata cut o ff of May 17, 2024 dom: domva nalimab; TEAE : treatment emer gent a dve rse event; zim: zimberelimab a. sud den death b. Eve nt each of
Slide 33: Phase 3 Dom + Zim + Chemo vs. Pembro + Chemo in 1L NSCLC
Phase 3 Evaluating Dom + Zim + Chemo vs. Pembro + Chemo in 1L NSCLC (All PD-L1 Subgroups) • Uses standard of care, pembrolizumab, in the comparator arm ELIGIBILITY CRITERIA: ARM A ENDPOINTS: • Metastatic NSCLC without dom + zim + platinum doublet PRIMARY actionable mutations (ARM A vs B) • No prior
Slide 34: Phase 3 Dom + Durva vs Placebo + Durva in Stage III NSCLC
Phase 3 Evaluating Dom + Durva vs Placebo + Durva in Unresectable, Stage III NSCLC • Combines domvanalimab (dom) with durvalumab (durva) standard-of-care in Stage III NSCLC • Potential to be first anti-TIGIT combination in this curative intent setting PATIENT POPULATION: ARM A (N=430) PRIMARY ENDPOI
Slide 35: Summary of EDGE-Gastric Arm-A1 Results in Upper GI Cancers
Summary of EDGE-Gastric Arm-A1 Results and Domvanalimab Plus Zimberelimab Clinical Program in Upper GI Cancers Data presented at 2024 ASCO Annual Meeting, based on data cut off of March 12, 2024. 35 © Arcus Biosciences 20 24
Slide 36: Arm A1: 1L Metastatic Gastric/GEJ/EAC Cohort
Arm A1: 1L Metastatic Gastric/GEJ/EAC Cohort EDGE-Gastric (NCT05329766) is a Phase 2 study evaluating the safety and efficacy of treatment combinations with and without chemotherapy in adults with advanced upper gastrointestinal tract malignancies KEY ELIGIBILITY CRITERIA • First-line locally advanc
Slide 37: Baseline Characteristics
Baseline Characteristics Arm A1 Arm A1 N=41, n (%) N=41, n (%) Mean age, years (range) 61 (30 to 82) Current disease status Locally advanced unresectable disease 3 (7) Female 17 (41) Metastatic disease 38 (93) Country Liver metastases 13 (32) United States/France 22 (54) Peritoneal metastases 15 (37
Slide 38: Meaningful Tumor Reduction Regardless of PD-L1 Status
Almost All Patients Experienced Meaningful Tumor Reduction, Regardless of PD-L1 Status 100 * Treatment status: Ongoing TAP Score Microsatellite instability status: High TAP ≥ 5% Best Percent Change from Baseline, % 60 TAP < 5% Missing 20 -20 * * * -60 * * * * * * * -100 * * On e p atie nt had no tis
Slide 39: Unprecedented Median PFS of 12.9 Months in Overall Population
Unprecedented Median PFS of 12.9 months in the Overall Population Efficacy-Evaluable (N=41) TAP ≥ 5% (n=16); TAP < 5% (n=24) Median, months Month 12 rate, % Median PFS follow-up Median, months Month 12 rate, % Median PFS follow-up Events, n (%) Events, n (%) (95% CI) (95% CI) time, months (95% CI) (
Slide 40: Dom + Zim + Chemo Potential New SOC in 1L Gastric/GEJ/EAC
Dom + Zim + Chemo Has the Potential to Become the New SOC in 1L Gastric/GEJ/EAC Data below are not from head-to-head studies. Cross-trial data interpretation should be considered with caution as it is limited by differences in study population, sample size, inclusion and exclusion criteria and many
Slide 41: Phase 3 Dom + Zim + Chemo vs Nivo + Chemo in 1L Gastric/GEJ/EAC
Phase 3 Evaluating Dom + Zim + Chemo vs Nivo + Chemo in 1L Gastric/GEJ/EAC STAR-221 is evaluating the same regimen in the same setting as EDGE-Gastric – and dom + zim has the potential to be the first anti-TIGIT combination approved for 1L Gastric/GEJ/EAC KEY ELIGIBILITY CRITERIA: N=970 • 1L locally
Slide 42: CD73-Adenosine Axis Programs
CD73-Adenosine Axis Programs 42 © Arcus Biosciences 20 24
Slide 43: Three Datasets Show Benefits of Combining Adenosine Blockade with Chemotherapy
Three Datasets in Six Months Demonstrate the Potential Benefits of Combining Adenosine Blockade with Chemotherapy 3L Colorectal Cancer 1L Metastatic PDAC 1L Metastatic PDAC etruma + zim + FOLFOX/bev vs. rego (n=112) quemli ± zim + G/nP (n=122) etruma + atezo + G/nP (n=35) 100 100 100 EZFB etruma + a
Slide 44: Etrumadenant: Potentially Best-in-Class Adenosine Receptor Antagonist
Etrumadenant Represents a Potentially Best-in-Class Adenosine Receptor Antagonist ETRUMADENANT Etrumadenant has an ideal profile • Highly potent small molecule that inhibits both the A2a and A2b receptors ✓ Retains potency in physiologically • Excellent penetration of tumor tissue relevant condition
Slide 45: Quemliclustat: Small Molecule CD73 Inhibitor with Key Attributes
Quemliclustat (quemli): A Small Molecule CD73 Inhibitor with Several Key Attributes QUEMLICLUSTAT • Highly potent small molecule Potential advantages over • Target coverage achieved at doses CD73 antibodies1 as low as 25 mg every two weeks • Extremely long (4+ days) half-life, enabling Q2W dosing by
Slide 46: Phase 3 Study of Quemli + Chemo in 1L Metastatic PDAC
Phase 3 Study of Quemli + Chemo in 1L Metastatic PDAC 1L mPDAC Stratification • ECOG 0/1 Arm A: Quemli 100mg Q2W + • Liver metastases GnP PRIMARY ENDPOINT: • Confirmed PDAC untreated • *Region • OS in metastatic setting • Metastatic disease diagnosed 2:1 within 6 weeks prior to KEY SECONDARY screeni
Slide 47: AXL Program
AXL Program 47 © Arcus Biosciences 20 24
Slide 48: AB801 is a Potent, Selective AXL Inhibitor
AB801 is a Potent, Selective AXL Inhibitor AXL signals via Ligand-dependent and AB801 is a highly potent Ligand-independent mechanisms and selective AXL inhibitor Assay AB801 AXL Ki 0.024 nM MERTK EGFR TYRO3 VEGFR HER2 Fold selectivity over hMERTK/ hTYRO3 860x / 1400x BIOC HEMI CAL (enzyme Ki over A
Slide 49: AB801 Potentially Most Potent & Selective AXL Inhibitor in Clinic
AB801 is Potentially the Most Potent & Selective AXL Inhibitor in Clinical Development THERAPEUTIC HYPOTHESIS: Inhibiting AXL will overcome resistance against chemotherapy and immunotherapy in human tumors • AB801 was designed to potently and selectively inhibit AXL signaling in tumors, resulting in
Slide 50: Phase 1 Dose-Finding Study in Advanced Solid Tumors
Phase 1 Dose-Finding Study in Patients with Advanced Solid Tumors PRE-SCREENING / SCREENING DOSE ESCALATION STAGE EXPANSION STAGE DOSE ESCALATION PRIMARY ENDPOINT • Safety / DLT AB801 SECONDARY ENDPOINT • PK • ORR AB801 EXPLORATORY ENDPOINTS Advanced Solid Cohort 1: NSCLC • Biomarkers / PD Tumors AB
Slide 51: Appendix
APPENDIX 51 © Arcus Biosciences 20 24
Slide 52: Expansive Development Plan with Multiple Phase Studies
Expansive Development Plan with Multiple Phase 3 Studies Ongoing or Planned in 2024 Program Disease Study Line & Regimen Ph 1/1b Ph 2 Ph 3 Upcoming Milestones 1L, PD-L1 all-comers, metastatic dom + zim + chemo vs pembro + chemo Stage 3: durva ± dom NSCLC 1L, PD-L1-high: dom+zim vs zim (p1) or pembro
Slide 53: Randomized Phase 2 Study in 1L PD-L1-High NSCLC
Randomized, Open-label, Ph2 Study in First-Line, Metastatic, PD-L1-High NSCLC ARM 1 STAGE IV NSCLC zim (Z) 360 mg IV Q3W KEY ELIGIBILITY: CO-PRIMARY ENDPOINTS • Treatment-naïve for • Investigator-assessed ORR & metastatic disease ARM 2 PFS per RECIST v1.1 R dom + zim (DZ) • PD-L1 ≥50%, locally 1:1:1
Slide 54: Final Overall Survival Analysis for Quemliclustat and Zimberelimab (ARC-8)
Final Overall Survival Analysis for Quemliclustat and Zimberelimab in Pancreatic Cancer (ARC-8) Data presented at ASCO GI, January 19, 2024, based on a data cutoff of June 19, 2023. 54 © Arcus Biosciences 20 24
Slide 55: Highlights from ARC-8, a Phase 1b Study in 1L PDAC
Highlights from the ARC-8, a Phase 1b Study in 1L PDAC Median overall survival (mOS) was 15.7 months for patients treated with a quemliclustat- based regimen, which exceeds the historical benchmark data for chemotherapy alone (8.5 – 11.7 months)1,2 A 37% reduction in risk of death and a 5.9-month im
Slide 56: ARC-8 Study Design
ARC-8 Study Design Included Dose Escalation, Expansion and Randomized Portions RANDOMIZATION DOSE ESCALATION DOSE EXPANSION (WITH AND WITHOUT ZIM) 125mg quemli IV Q2W + G/nP + zim (n=3-6) COHORT A1 100mg QZ + G/nP (n=61) COHORT A 100mg quemli IV Q2W + R 1L mPDAC G/nP + zim (n=6) RDE 100mg QZ + G/nP
Slide 57: Dataset Includes Four Groups of Patients Treated with 100 mg of Quemli
Dataset Includes Four Groups of Patients Treated with 100 mg of Quemli Quemli Cohort Combination Participants Dosed >18m OS f/u? Population Dose Dose escalation 25mg Q + Z + G/nP (quad) 4 Yes 1L mPDAC Dose escalation 50mg Q + Z + G/nP (quad) 6 Yes 1L mPDAC Dose escalation 75mg Q + Z + G/nP (quad) 3
Slide 58: Demographics And Baseline Characteristics Well Balanced
Demographics And Baseline Characteristics Are Well Balanced Across Arms & Efficacy-evaluated Populations % ECOG 1 (65%-69%) Was Higher than Historical G/nP Studies (42-57%); % Liver Mets (59%-69%) Was Slightly Lower than Historical G/nP Studies (78-85%) A2: Q + G/nP A1: QZ + G/nP Pooled Q100 QZ + G/
Slide 59: OS Results Exceed Ph3 Benchmarks for G/nP
With 21-month Median Follow-up, OS Results Exceed Ph3 Benchmarks for G/nP Phase 3 G/nP median OS G/nP Benchmarks1,2 Benchmark Median OS 8.5 – 11.1 months CI: co nfid ence in ter val; G/nP: g emcitabine /na b-paclitaxel; Ph3 : Phase 3 1. Abraxane USPI, 202 0 a nd Wa inberg ZA, Melisi D, Ma car ulla T
Slide 60: Favorable OS for Patients With & Without Liver Metastasis
Favorable OS for Patients With & Without Liver Metastasis • Because ARC-8 had a lower incidence of liver mets than historical studies, we analyzed the OS for ARC-8 patients with and without liver mets as shown below • When adjusting for the lower incidence of liver mets in the triplet arm, mOS for t
Slide 61: Safety Profile Similar to G/nP
Safety Profile Similar to G/nP with Regards to Overall TEAEs NAPOLI-3 G/nP A2: Q + G/nP Pooled Q100 QZ + G/nP All Pooled Q100 Q % Benchmark4 (n=29) (n=93) (±Z)+G/nP (n=122) (n=379) Any TEAE 100 100 100 99 Any TRAE 100 98.9 99.2 93 Grade 3-5 TEAE 89.7 83.9 85.2 86 Grade 3-5 TRAE 75.9 72.0 73.0 68 Ser
Slide 62: Arcus & Medidata AI Synthetic Control Arm Project
Arcus & Medidata AI Synthetic Control Arm (SCA) Project • Developed in collaboration with Medidata, the industry’s leading provider of electronic data capture for clinical trials • Constructed SCA using historical data from patients treated with G/nP alone and balanced to the patient baseline charac
Slide 63: Quemli-based Regimen Reduced Risk of Death by 37%
Quemli-based Regimen Reduced Risk of Death by 37% and increased mOS by 5.9 months Compared to SCA CI: co nfid ence in ter val; mOS: med ian ove rall sur vival; q uemli: que mliclustat; SCA: Synthetic Control Arm 63 Wainbe rg ZA, et al. ASCO GI, Jan. 1 9, 202 4, data cut off of Ju ne 19, 20 23 © Arcu
Slide 64: Summary of ARC-9 Results
Summary of ARC-9 Results Data presented at 2024 ASCO Annual Meeting, based on data cut off of November 13, 2023. 64 © Arcus Biosciences 20 24
Slide 65: ARC-9 Cohort B: EZFB vs Regorafenib in 3L mCRC
ARC-9 Cohort B: Etruma + Zim + mFOLFOX6 + Beva (EZFB) vs Regorafenib (Rego) in 3L mCRC PRIMARY ENDPOINTS: Etruma* + zim + mFOLFOX6 + beva • PFS (investigator 2 (n=75) assessed) R E COHORT Post-oxaliplatin and G KEY SECONDARY 3L R I ENDPOINTS: B irinotecan O N • OS Regorafenib** 1 (n=35) • ORR (inves
Slide 66: Prior Performance on FOLFOX Consistent With Historical 1L Data
Prior Performance on FOLFOX Is Consistent With Historical 1L Data • Patients previously performed in-line with expectations for FOLFOX + bev in prior lines • Prior performance in FOLFOX was well-balanced between arms EZFB REGO (N=75) (N=37) Time from first oxaliplatin dose date to progression/discon
Slide 67: EZFB Statistically Significant Improvement in PFS vs Rego
EZFB Demonstrated Statistically Significant Improvement in PFS vs Rego EZFB Rego Patients with event, n (%) 58 (77) 34 (92) Median PFS (95% CI), months 6.24 (5.49, 7.52) 2.07 (1.84, 2.96) Hazard ratioa (95% CI) 0.27 (0.17, 0.43) P-value <0.001 2.07 months 6.24 months mPFS 6-month PFS rate, % 54 6 mP
Slide 68: EZFB Significant Improvement in OS vs Rego
EZFB Demonstrated Significant Improvement in OS vs Rego EZFB Rego Patients with event, n (%) 34 (45) 26 (70) 19.68 9.49 Median OS (95% CI), months 19.68 months mOS (14.69, 20.60) (7.95, 12.52) EZFB Hazard ratioa (95% CI) 0.37 (0.22, 0.63) P-value <0.001 6-month OS rate, % 90 71 12-month OS rate, % 6
Slide 69: Median PFS and OS for EZFB in Patients With Liver Metastasis
5.7 Month Median PFS and 20 Month Median OS for EZFB in Patients With Liver Metastasis EZFB Rego EZFB Rego Patients with events , n (%) 45 (85) 28 (97) Patients with events , n (%) 27 (51) 22 (76) Median PFS, months 5.65 1.97 Median OS, months 19.68 9.13 Hazard ratio (95% CI) 0.19 (0.10, 0.35) Hazar
Slide 70: Two-Thirds of Patients on EZFB Experienced Tumor Reduction
Two-Thirds (66%) of Patients on EZFB Experienced Tumor Reduction EZFB REGO Sum of Target Lesion Best Percent Change from Baseline (%) Sum of Target Lesion Best Percent Change from Baseline (%) • Confirmed ORR for EZFB: 17.3% • Confirmed ORR for rego: 2.7% • Median DOR for EZFB: 11.5 months • Median
Slide 71: EZFB Had an Acceptable Safety Profile
EZFB Had an Acceptable Safety Profile, Consistent With Known Toxicity Profile of FOLFOX/bev in Combination With Anti-PD-1 n (%) EZFB (N=74) Rego (N=35) Median treatment duration, weeks 26 7 Any TEAEs 73 (99) 31 (89) Serious TEAEs 37 (50) 9 (26) Grade ≥3 TEAEs 61 (82) 17 (49) Any TEAEs leading to dis
Slide 72: Conclusions
Conclusions This is the first randomized, Phase 2, proof-of-concept study showing EZFB significantly improves PFS and OS compared with standard of care in microsatellite-stable 3L mCRC • Longest OS reported for a randomized clinical trial in 3L mCRC • Meaningful improvement shown across all subgroup
Slide 73: Combining to Cure
RCUS BIOSCIENCES COMBINING TO CURE*