Bristol-myers Squibb Company · NYSE:BMY
Bristol-myers Squibb — ESMO 2024
31 slides from Bristol-myers Squibb's conference presentation, September 2024
Slide 1: ESMO 2024 Investor Presentation
ESMO 2024 Investor Presentation September 2024
Slide 2: Forward looking statements
Forward looking statements This presentation (as well as the oral statements made with respect to information contained in this presentation) contains statements about Bristol-Myers Squibb Company’s (the “Company”) future financial results, plans, business development strategy, anticipated clinical
Slide 3: Samit Hirawat
ESMO 2024 Samit Hirawat Executive VP Chief Medical Officer Head of Global Drug Development Not for Product Promotional Use 3
Slide 4: BMS presents exciting data in oncology at ESMO 2024
BMS presents exciting data in oncology at ESMO 2024 Advancing IO development Opdivo + Yervoy Subcutaneous Nivolumab Nivolumab + Relatlimab HD (CM-067 - Phase 3) (CM-67T - Phase 3) (RELA-104 - Phase 2) 10-year data 15-month data supports Advancing into Phase 3 with in metastatic improved patient & he
Slide 5: Significant progress advancing our leadership in cancer drug development
We are extending in IO • Entered Phase 3 with Nivolumab & Relatlimab HD in 1L NSCLC Significant • Filed Subcutaneous Nivolumab: U.S. FDA PDUFA date Dec 29th progress advancing our Significantly expanding registrational pipeline leadership in • 8 new trials across solid tumors spanning multiple cance
Slide 6: Strong foundation in IO & broadening modalities beyond IO
Strong foundation in IO & broadening modalities beyond IO IO & Biologics Cell Therapy Protein Degradation AR LDD Helios CELMoD* HbF Activating BCL6 LDD* CELMoD* Nivolumab + Subcutaneous BCMA x GPRC5D GPRC5D CAR T CK1α Degrader iberdomide Relatlimab HD nivolumab1 Dual Targeting CAR T* mezigdomide gol
Slide 7: RELATIVITY-104: 1L NSCLC signal detecting Phase 2 study
RELATIVITY-104: 1L NSCLC signal detecting Phase 2 study Key Inclusion1: • 1L stage IV/recurrent NSCLC N=309 • No prior systemic therapy for metastatic disease • No EGFR, ALK, ROS-1 mutations • ECOG PS 0–1 Nivolumab + Relatlimab HD IV (360 mg/360 mg) + PDCT Q3W Primary Endpoint: ORR Patients Prophyla
Slide 8: RELATIVITY-104: 1L NSCLC safety summary
RELATIVITY-104: 1L NSCLC safety summary Part 2 Results Nivo + Rela 360 mg + PDCT Nivo + PDCT n=158 n=149a Ongoing treatment,b n (%) 38 (24) 44 (30) Safetyc Any grade Grade 3/4 Any grade Grade 3/4 All-cause AEs, n (%) 158 (100) 112 (71) 148 (99) 104 (70) TRAEs, n (%) 147 (93) 86 (54) 138 (93) 82 (55)
Slide 9: RELATIVITY-104 demonstrates LAG-3 benefit across patient subgroups in 1L NSCLC
RELATIVITY-104 demonstrates compelling LAG-3 benefit across patient subgroups in 1L NSCLC RELA-104 Part 2 Results mPFS, mo ORR, % (90% CI) (90% CI) PFS HR (90% CI) Nivo + Rela Nivo + Rela Nivo + PDCT Nivo + PDCT Subgroup, na,b 360 mg + PDCT 360 mg + PDCT PD-L1 expressionc 9.8 6.1 0.63 53.2 40.8 ≥ 1%
Slide 10: RELATIVITY-104: LAG-3 enriches efficacy in PD-L1 1-49% & NSQ
RELATIVITY-104: LAG-3 enriches efficacy in PD-L1, 1-49% & NSQ in 1L NSCLC patients Robust response rates Improvement in PFS NIVO + RELA 360 mg NIVO PR CR + PDCT + PDCT n=28 n=20 Median PFS, 9.8 5.5 mo (90% CI) (5.6–NR) (2.2–7.0) 100 NIVO + RELA 60.7% HR (90% CI) 0.45 (0.25–0.81) 360 mg (17/28) 75 +
Slide 11: Phase 2 data in 1L NSCLC compared to historical control
Phase 2 data in 1L NSCLC compared to historical control provides confidence in our Phase 3 strategy PD-L1 (1-49%) & NSQ segment Historical SOC reference Nivo + Rela HD + Chemo Pembroluzimab + Chemotherapy RELA-104 KEYNOTE-189 Velcheti Liu Waterhouse Phase 2 Phase 31 RWD 20212 RWD 20223 RWD 20244 N=2
Slide 12: Nivolumab + Relatlimab HD: 1L NSCLC Phase 3 trial design
Nivolumab + Relatlimab HD: 1L NSCLC Phase 3 trial design Key Inclusion1: N=800 • Previously untreated, histologically confirmed stage IV or recurrent non-squamous NSCLC • PD-L1 expression 1-49% Nivolumab + Relatlimab FDC IV (360 mg/360 mg) + PDCT Q3W • No EGFR, ALK, ROS-1, BRAF, RET, NTRK mutations
Slide 13: Data supports extending 1L NSCLC development to PD-L1≥50% & NSQ patients
Data supports extending 1L NSCLC development to PD-L1≥50% & NSQ patients Promising efficacy Solid PFS benefit observed NIVO + RELA 360 mg NIVO PR CR + PDCT + PDCT n=22 n=28 Median PFS, 13.8 7.1 mo (90% CI) (4.6–NR) (4.2–13.9) 100 NIVO + RELA 54.5% HR (90% CI) 0.60 (0.31-1.15) 360 mg (12/22) 75 NIVO
Slide 14: Nivolumab + Relatlimab HD Phase 3 programs advancing in 1L NSCLC
Nivolumab + Relatlimab HD Phase 3 programs advancing in 1L NSCLC Demonstrated improved benefit adding LAG-3 to PD-1 & PDCT Clinical data supports further Phase 3 investigation Phase 3 trial initiating in PD-L1, 1-49% & NSQ patients Developing Phase 3 trial in PD-L1 ≥50% & NSQ patients, potential to
Slide 15: Addressing significant unmet medical need in lung cancer
Addressing significant unmet medical need in lung cancer 1L NSCLC1 Treated Population2: U.S.: ~105K & EU5: ~120K NSQ SQ Histology 75% 25% Nivolumab + <1% 1-49% ≥50% PD-L1 Status 3 Relatlimab HD 30-35% 40-45% 25-30% EGFR ALK ROS1 PRMT5i EGFRxHER3 AGA ~13% ~5% 20-25% 1L SCLC1 Treated Population: U.S.:
Slide 16: Anti-Fucosyl GM1: Effective treatments needed in 1L ES-SCLC
Anti-Fucosyl GM1: Effective treatments needed in 1L ES-SCLC • SCLC is a life-threatening disease Antibody- Anti-fucosyl GM1 (BMS-986012) representing ~15% of all lung cancer dependent cellular cases, & has poor survival outcomes1,2,3 phagocytosis Increased T-cell antitumor — Extensive-stage: ~70% of
Slide 17: Anti-Fucosyl GM1 combined with nivolumab & chemotherapy shows promising efficacy
Anti-Fucosyl GM1 combined with nivolumab & chemotherapy shows promising efficacy At the February 2024 Progression-free survival (Primary endpoint)a: Median PFS was 5.8 mo (95% CI, 5.0–7.9) with BMS-986012 + NIVO + chemo vs 5.1 mo data cutoff (median (95% CI, 4.8–6.6) with NIVO + chemo; HR 0.81 (95%
Slide 18: Anti-Fucosyl GM1 combined with nivolumab & chemotherapy safety summary
Anti-Fucosyl GM1 combined with nivolumab & chemotherapy safety summary BMS986012 + Nivolumab + Chemotherapy (n=66) Nivolumab + Chemotherapy (n=64) Patients, n (%) Grade 1/2 Grade 3/4 Grade 1/2 Grade 3/4 Most Frequent TRAEs Pruritus 36 (55) 4 (6) 10 (16) 0 Neutropenia 5 (8) 18 (27) 2 (3) 18 (28) Thro
Slide 19: Strong foundation in IO & broadening modalities beyond IO
Strong foundation in IO & broadening modalities beyond IO IO & Biologics Cell Therapy Protein Degradation AR LDD Helios CELMoD* HbF Activating BCL6 LDD* CELMoD* Nivolumab + Subcutaneous BCMA x GPRC5D GPRC5D CAR T CK1α Degrader iberdomide Relatlimab HD nivolumab1 Dual Targeting CAR T* mezigdomide gol
Slide 20: AR LDD Case Study: MoA validated in mCRPC
AR LDD Case Study: MoA validated in metastatic castrate resistant prostate cancer Target Lesion Reduction*1 69-year-old male with mCRPC Screening On Treatment 5 prior therapies including enzalutamide & talazoparib Patient entered study with AR amplification & BRCA2 mutation Treated with AR LDD; resp
Slide 21: AR LDD: Dual AR degrader & antagonist showing clinical benefit in mCRPC
AR LDD: Dual AR degrader & antagonist showing clinical benefit in mCRPC patients Clinical benefit observed in patients both with AR LBD WT and LBD mutant Endpoint 400 mg BID (n=20) 600 mg BID (n=20) 900 mg BID (n=20) PSA30, % (n) 30% (6) 45% (9) 70% (14) Median rPFS, mo. (95% CI)1 5.5 (2.7-NE) 5.5 (
Slide 22: Extending first-in-class bispecific EGFRxHER3 ADC
Potential Extendingfirst-in-class bispecific (EGFRxHER3) in IO while diversifying beyond IO ADC targeting advanced solid tumors αEGFR • Compelling, single agent activity in Phase 1 Human EGFR data1 in multiple solid tumors Affinity: High — NSCLC, breast cancers, bladder, & GI DAR = 8 Cat B cleavable
Slide 23: EGFRxHER3 ADC: Early clinical data establishes proof of concept
EGFRxHER3 ADC: Early clinical data establishes proof of concept for future registrational opportunities Single agent data in China-only studies 2 3 4 ESMO 2023 SABC 2023 ESMO 2024 • Promising anti-tumor activity EGFRmut NSCLC TNBC HER2-/HR+ UC observed in refractory patients N 40 35 38 12 Prior trea
Slide 24: RayzeBio: Leading innovation in radiopharma therapies
RayzeBio: Leading innovation in radiopharma therapies State-of-the-art Lead program Robust manufacturing RYZ101 IND engine facility Actinium-based alpha emitter RPT: Higher potency, potential for stronger efficacy & more targeted delivery Not for Product Promotional Use 24
Slide 25: RYZ101: Lead asset & interim clinical data
RYZ101: Lead asset & interim clinical data RYZ101(225AC-DOTATE) Ph 1b/3 ACTION-1 (GEP-NETs)2 • Targets SSTR2 expressed in multiple cancers Summary of ORR (investigator-assessed) • 2030 U.S. target population1 in the efficacy-evaluable population — GEP-NETs: ~5K patients (~90% SSTR2 expression) Respo
Slide 26: RYZ101 case study: Near complete response in metastatic breast cancer
RYZ101 case study: Near complete response observed in metastatic breast cancer 59-year-old female with ER+ breast Study from dotatate imaging1,2 cancer & severe dyspnea ER+ breast cancer patient 11 prior therapies including ER antagonist, CDK4/6i, & multiple chemotherapies Patient entered study with
Slide 27: RayzeBio: Leading pipeline of RPT candidates
RayzeBio: Leading pipeline of RPT candidates Clinical programs complemented by robust IND engine Target IND P1 P2 P3 Status 1 SSTR2 RYZ101(225Ac): GEP-NETs Registrational data expected in 2026 SSTR2 RYZ101(225Ac): ES-SCLC Phase 1b data expected in 2025 RYZ101-201(225Ac)*: Phase 1/2 trial underway SS
Slide 28: MTA-Cooperative PRMT5i: Potential transformative agent targeting ~10% of cancers
MTA-Cooperative PRMT5i: Potential transformative agent targeting ~10% of cancers Unmet Need1 Clinical Development1,3 • MTAP deletion prevalent in several cancers • Encouraging early data: (e.g., NSCLC, PDAC) — Efficacy signal across multiple tumors including NSCLC • Poor prognosis due to shorter OS
Slide 29: 8 new registrational trials added in oncology since last year
8 new registrational trials added in oncology since last year Registrational programs Studies underway Newly planned EGFRxHER3 Anti-Fucosyl RYZ101 Nivo + Rela HD Nivo + Rela HD AR LDD ADC GM1 2L CRC 2L+ GEP-NETs 1L NSCLC 1L NSCLC 1L NSCLC 1L ES-SCLC Solid tumors mCRPC PD-L1≥50% PD-L1 1–49% & NSQ PD-
Slide 30: Significant progress advancing our leadership in cancer drug development
We are extending in IO • Entered Phase 3 with Nivolumab & Relatlimab HD in 1L NSCLC Significant • Filed Subcutaneous Nivolumab: U.S. FDA PDUFA date Dec 29th progress advancing our Significantly expanding registrational pipeline leadership in • 8 new trials across solid tumors spanning multiple cance
Slide 31: Q&A
Q&A Samit Hirawat Executive VP Chief Medical Officer Head of Global Drug Development Not for Product Promotional Use 31