Gsk Plc · LSE:GSK
Gsk — Investor Presentation (December 2024)
40 slides from Gsk's investor presentation, Dec 10, 2024
Slide 1: Post-ASH Blenrep investor call
Post-ASH Blenrep investor call 10 December 2024 gsk.com
Slide 2: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly t
Slide 3: Today's agenda and speakers
Today’s agenda and speakers Luke Miels Paul G. Richardson, MD Nina Mojas Hesham Abdullah, MD Mondher Mahjoubi, MD Chief Commercial Officer Dana-Farber Cancer Institute SVP, Global Product Strategy SVP, Global Oncology R&D SVP, Chief Patient Officer Strategic context for DREAMM-7 OS Positioning of De
Slide 4: Multiple Oncology approvals in the next 3-5 years
Multiple Oncology approvals in the next 3-5 years, expanding into a range of solid tumours with significant unmet need Estimated approval timelines across Oncology portfolio Launched 2025 2026 2027+ Ojjaara Blenrep Blenrep Haematologic Myelofibrosis 2L+ MM (DREAMM-7/8) 1L MM (DREAMM-10) Jemperli End
Slide 5: Blenrep summary
Blenrep summary • Blenrep combination shows statistically significant and clinically meaningful overall survival benefit, reducing the risk of death by 42% in RRMM compared to daratumumab- containing standard of care1 • Blenrep could be transformational for patients and physicians across both commun
Slide 6: DREAMM-7 OS update
DREAMM-7 OS update Paul G. Richardson, MD Dana-Farber Cancer Institute gsk.com https://annualmeeting.hematology.org/session/250891
Slide 7: Blenrep multimodal mechanism of action
Blenrep multimodal mechanism of action ADC BCMA-targeting monoclonal BCMA antibody conjugated with a cytotoxic Lysosome payload (MMAF) # Effector cell ADCC/ADCP • Payload induced direct cell death BCMA " Malignant Fc receptor (afucosylated) plasma cell • Antibody engineered to have Immunogenic ADCC
Slide 8: DREAMM-7: Study design and endpoints
DREAMM-7: Study design and endpoints Cycle 1-8 Cycle 9+ Eligibility criteria Endpoints and • Adults with MM BVd Belamaf analysis plan • ≥1 prior line of MM therapy, (belamaf, bortezomib, dexamethasone) monotherapy and documented PD during PFS or after their most recent R therapy 1:1 OS / DoR • No pr
Slide 9: Baseline characteristics and prior treatments balanced across both arms
Baseline characteristics and prior treatments received were balanced across both arms ITT population Baseline characteristics BVd (N=243) DVd (N=251) Age, median (range), years 65.0 (34-86) 64.0 (32-89) Male, n (%) 128 (53) 144 (57) ECOG PS ≤1, n/N (%) 232/242 (96) 235/246 (96) R-ISS stage at screen
Slide 10: BVd nearly tripled median PFS vs DVd
BVd nearly tripled median PFS vs DVd (36.6 vs 13.4 months) 18 months 1.0 69% 0.8 Median 36.6 BVd DVd PFS probability, % PFS months (N=243) (N=251) 0.6 Events, n (%) 91 (37) 158 (63) PFS, median 36.6 13.4 0.4 Median (95% CI), mo (28.4-NR) (11.1-17.5) 13.4 months HR 0.41 0.2 43% (95% CI) (0.31-0.53) B
Slide 11: BVd had an early, sustained, significant overall survival benefit
BVd had an early, sustained, and statistically significant Overall Survival benefit vs DVd 24 month 36 month 1.0 79% BVd DVd 74% OS (N=243) (N=251) 0.8 Events, n (%) 68 (28) 103 (41) OS probability OS, median (95% NR NR 0.6 CI), months (NR, NR) (41.0,NR) 67% 60% HR (95% CI) 0.58 (0.43-0.79) 0.4 P va
Slide 12: Deeper responses with BVd vs DVd
Deeper responses reported with BVd vs Dvd with statistically significant MRD(-) benefit MRD(-) benefit 90 ORR 83.1% BVd DVd 80 Patients, (95% CI), % sCR:14.4 ORR 71.3% (N=243) (N=251) 70 sCR: 5.6 ≥ CR: 35.8% ≥ CR and MRD 25.1 10.4 Patients, % 60 CR: 12 ≥ CR: 17.5% negativityb (19.8, 31.0) (6.9, 14.8
Slide 13: Duration of Response with BVd more than double that of DVd
Duration of Response with BVd was more than double that of DVd 1.0 Duration of BVd DVd Ongoing response probability Response (DOR) (N=243) (N=251) 0.8 mDOR 40.8 Responders, n 202 179 0.6 Events, n (%) 86 (43) 114 (64) Patients with 0.4 mDOR ongoing response, 79 (39) 39 (22) 17.8m n (%) 0.2 DOR, medi
Slide 14: Eye-related side effects were manageable and reversible
Eye-related side effects were manageable and reversible 20/20 20/50 20/200 Reprinted from Shi C, et al. J Vis. 2020;20(8):29. Copyright © 2020 The Authors. Bilateral worsening of BCVA in patients with normal baseline 20/25 or better BVd 20/50 or worse 20/200 or worse Patients, n/N (%) 84/242 (35) 5/
Slide 15: Conclusions
Conclusions • BVd is the only triplet combination compared with an anti-CD38 monoclonal antibody triplet (DVd) that has demonstrated • an early and sustained separation of OS KM curves • Statistically significant survival benefit; HR of 0.58, p=.00023 • Predicted mOS based on modeling: 84 months for
Slide 16: Relevance for clinical practice
Relevance for clinical practice Paul G. Richardson, MD Dana-Farber Cancer Institute gsk.com
Slide 17: Blenrep is highly efficacious option for 2L MM
Blenrep is highly efficacious option for 2L MM Overall Survival benefit across DREAMM-71 and DREAMM-82 HR 0.58 p=0.00023 HR 0.77 • Depth and durability of response: CR/sCR rates and DoR doubled; 2.5-5x MRD(-) improvement • Eye-related side effects: 1) Managed with dose modifications without impactin
Slide 18: High response rates maintained with extended Blenrep dosing
DREAMM-7: High response rates maintained with Blenrep dosing extended to ~8–12 weeks Percent ≥ PR Percent bilateral 20/50 or worse Percent discontinued due to ophthalmic exam finding or ocular ARs 120 14 Average time between doses, median, weeks 12 12 96.2 96.6 96.1 96.9 11 12 100 95.2 93.6 11 96.8
Slide 19: Summary
Summary • Blenrep is highly efficacious option for all 2L MM patient segments* • Blenrep dosing in clinical studies extends to ~8-12weeks • Majority of Grade3/4 eye-related side effects were blurred vision and were manageable and reversible • Blenrep-based regimens can be used across all care settin
Slide 20: Positioning of Blenrep in RRMM
Positioning of Blenrep in RRMM Nina Mojas SVP, Oncology Global Product Strategy gsk.com
Slide 21: 1st relapse in MM is a critical moment in evolving treatment landscape
1st relapse in MM is a critical moment in evolving treatment landscape Need to use the most effective At 1st relapse, majority of 2L patients will be Len exposed treatments at 1st relapse Historic 1L market Projected pretreatment profile (2022-2023) for 2L patients in 2025 38k new patients per year
Slide 22: Blenrep offers option with OS benefit and low treatment burden
Blenrep offers option with Overall survival benefit and low treatment burden* Blenrep3 CAR-T (Cilta-cel)1,2 Bi-specific (Teclistamab) % surviving w/o progression No OS data OS available HR : 0.55 Cilta-cel HR 0.58 P=0.0009 SoC p=0.00023 Deep and durable response maintained Rapid, deep and durable re
Slide 23: Blenrep as an option for patient segments across care settings in 2L MM
Blenrep as an option for patient segments across care settings in 2L MM Young / Fit Patient Age / Fitness Old / Frail sites of care Current Standard DKd, KPd DPd, PVd All of Care (no cardiac nor other comorbidity) CAR-Ts sites of care Academic (hospitalization required in US) Bispecifics (hospitaliz
Slide 24: Market research shows strong momentum for anti-BCMA therapies and Blenrep
Quantitative market research show strong momentum for anti-BCMA therapies and Blenrep Anti-BCMAs expected to dominate across Proportion of US physicians who intend to fit/intermediate fit populations prescribe BLENREP March1 vs August 20242 March 2024 (n=74) August 2024 (n=150) Stated future Line of
Slide 25: Development program in Newly Diagnosed Multiple Myeloma (NDMM)
Development program in Newly Diagnosed Multiple Myeloma (NDMM) Hesham Abdullah, MD SVP, Head of Oncology R&D gsk.com
Slide 26: Ph1 DREAMM-9 Blenrep Quad in Transplant-Ineligible NDMM
Ph1 DREAMM-9 Blenrep Quad (BVRd) in Transplant-Ineligible Newly Diagnosed Multiple Myeloma 1.9 mg/kg Q3/4W, 1.9 mg/kg Q6/8W Primary endpoint Belamaf 1.4 mg/kg Q3/4W Safety Transplant-Ineligible + Newly Diagnosed Secondary endpoint VRd# 1.4 mg/kg Q6/8W Efficacy [ORR, MRD(-)] Multiple Myeloma bortezom
Slide 27: Blenrep Quad achieved response of 100% at doses 1.4-1.9mg/kg
Blenrep Quad achieved response of 100% at doses 1.4-1.9mg/kg and with schedules of 6-8 weeks ORR, % 100 100 92 100 71 86 87 100 100 8 9 9 90 PR 17 7 80 13 VGPR 31 7 Proportion of patients, % 70 CR 12 20 70 sCR 60 25 58 64 36 50 18 7 40 46 12 30 50 47 20 33 36 27 29 30 10 15 0 1.9 mg/kg Q3/4W 1.9 mg/
Slide 28: High rates of MRD(-) achieved with extended schedules
High rates of MRD(-) achieved at doses 1.4-1.9mg/kg and with extended schedules of 6-8 weeks 100 Patients (ITT population), % MRD[-] 90 80 75 70 67 60 54 50 45 43 40 29 27 30 20 10 0 0 1.9 mg/kg 1.9 mg/kg 1.4 mg/kg 1.4 mg/kg 1.9 (9W) to 1.0 mg/kg 1.4 (9W) to 1.0 mg/kg Q3/4W Q6/8W Q3/4W Q6/8W 1.4 mg/
Slide 29: Preliminary DREAMM-9 Safety: Grade 3/4 event rates
Preliminary DREAMM-9 Safety: Grade 3/4 event rates reduce with extended schedules 1.9 (9W) to 1.4 (9W) to 1.9 mg/kg 1.9 mg/kg 1.4 mg/kg 1.4 mg/kg 1.0 mg/kg 1.0 mg/kg Belamaf schedule 1.4 mg/kg 1.0 mg/kg Total Q3/4W Q6/8W Q3/4W Q6/8W Q3/4W Q12W Q9/12W Q9/12W n 12 12 13 12 17 14 15 10 N=105 Median fol
Slide 30: BLENREP quad could yield improved efficacy vs anti-CD38 quads
BLENREP quad could yield improved efficacy vs anti-CD38 quads in ALL NDMM patients, including high risk BVRd (DREAMM-9) and Isa-VRd (IMROZ) in an all-comers population ORR ≥VGPR MRD negativity (10-5) BVRd1 1.9 mg/kg 100% 100% 67% Q8W ORR ≥VGPR MRD negativity (10-5) Isa-VRd2 10 mg/kg 91% 89% 56% Q1/2
Slide 31: Blenrep triplet in NDMM showed 100% ORR and no progression
In addition, Blenrep triplet in NDMM showed 100% ORR and no disease progression to date 100% ORR across all cohorts At median follow up of 24.8 months, no Median time to first response: ~1 month disease progression was observed* *PFS Events: 8 deaths: COVID-19: 4 patients; Pneumonia: 2 patients; Sud
Slide 32: Study design for Blenrep triplet in 1L (DREAMM-10)
Study design for Blenrep triplet in 1L (DREAMM-10) DREAMM-10 (phase III): Blenrep in 1L multiple myeloma BRd Newly (belamaf, lenalidomide, dexamethasone) Dual Primary diagnosed R endpoints: multiple 1:1 DRd MRD negativity1, myeloma (daratumumab, lenalidomide, dexamethasone) PFS Trial expected to ini
Slide 33: Summary Q&A
Summary Q&A gsk.com
Slide 34: Blenrep is well positioned to improve outcomes in RRMM
Blenrep is well positioned to improve outcomes in RRMM Blenrep is the only anti-BCMA • Blenrep combination shows statistically treatment that has the potential to significant and clinically meaningful overall address multiple patients’ needs survival benefit, reducing the risk of death by 42% in RRM
Slide 35: Appendix
Appendix gsk.com
Slide 36: Luke Miels
Luke Miels Chief Commercial Officer Luke Miels joined GSK and the GLT in 2017. As Chief Commercial Officer he is responsible for our commercial portfolio of medicines and vaccines. Luke also co-chairs the Portfolio Investment Board with Tony Wood and is a member of the ViiV Healthcare Board. Outside
Slide 37: Paul G. Richardson, MD
Paul G. Richardson, MD Dana-Farber Cancer Institute Paul Richardson, MD - After certification in Internal Medicine, Hematology and Medical Oncology, as well as working in Cancer Pharmacology and stem cell transplant from 1994 onwards at Dana-Farber Cancer Institute (DFCI), Dr. Richardson joined the
Slide 38: Nina Mojas
Nina Mojas SVP, Global Product Strategy Nina Mojas is the Senior Vice President of Global Product Strategy, Oncology. Her extensive experiences, expertise in oncology, and her global, strategic mindset is an asset to the GSK commercial organisation as the focus is on delivering transformational medi
Slide 39: Hesham Abdullah, MD
Hesham Abdullah, MD SVP, Global Oncology R&D Hesham A. Abdullah, MD, is Senior Vice President and Global Head of Development, Oncology at GSK, where he oversees the end-to-end strategic development and delivery of GSK’s oncology clinical-stage portfolio. Hesham is a proven global drug developer whos
Slide 40: Mondher Mahjoubi, MD
Mondher Mahjoubi, MD SVP, Chief Patient Officer Dr. Mondher Mahjoubi is the Chief Patient Officer of GSK Pharma. He was previously chief executive officer and chairman of the executive board at Innate Pharma. Prior to joining Innate, Dr. Mahjoubi led AstraZeneca’s oncology therapy area franchise, pl