Gsk Plc · LSE:GSK
Gsk — Investor Day (June 2024)
62 slides from Gsk's investor day presentation, Jun 17, 2024
Slide 1: Meet GSK management Oncology: Getting ahead of cancer
17 June 2024 Meet GSK management Oncology Getting ahead of cancer Interactive event for investors and analysts. This webinar is being recorded. 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 focus
Today’s focus • Material growth opportunities across haematology, gynaecologic cancers and other tumour types • Multi-blockbuster potential of Blenrep delivering statistically significant, robust efficacy with manageable toxicity profile • Regulatory filing in all major markets in H2 2024 • Future o
Slide 4: Participants
Participants Speakers Luke Miels Dr Tony Wood Dr Evangelos Terpos Chief Commercial Officer Chief Scientific Officer Professor of Haematology National and Kapodistrian University of Athens DREAMM-8 Principal Investigator Q&A Dr Nina Mojas Dr Hesham Abdullah Dr Mondher Mahjoubi SVP, Global Product Str
Slide 5: Focused on core therapy areas
Focused on core therapy areas Emerging oncology portfolio focused on blood and gynaecologic cancers, and are seeking to make transformative breakthroughs Infectious Respiratory/ HIV Oncology Diseases Immunology Arexvy Long-acting and ultra-long-acting depemokimab Blenrep MenABCWY N6LS (bNAb) camlipi
Slide 6: Oncology is a significant, emerging contributor to our long-term ambitions
Oncology is a significant, emerging contributor to our long-term ambitions Oncology growth drivers Oncology growth drivers 2027-31 2024-26 • Blenrep1 in multiple myeloma • Jemperli monotherapy or IO combinations in CRC, HNSCC and NSCLC • Jemperli in endometrial • CD226 axis combinations in solid tum
Slide 7: Focused oncology strategy with potential for expansion
Focused oncology strategy with potential for expansion Significantly differentiated medicines with heavily gated investments belantamab mafodotin (belamaf) myelofibrosis multiple myeloma (DREAMM) Haematology endometrial dostarlimab + niraparib GSK5733584 (B7-H4) endometrial (RUBY Part 2) endometrial
Slide 8: Blenrep (belantamab mafodotin)
Blenrep (belantamab mafodotin) Potential standard of care treatment for 2L multiple myeloma 8
Slide 9: Multiple myeloma patients cycle through treatment combinations
Multiple myeloma patients cycle through treatment combinations Time to next relapse is short with many therapies limited by tolerability and practicality of administration Multiple myeloma market by 20311,2 Treatment dynamics, US3 Treatment dynamics, US3 ~£36bn +10% compound growth rate 70% 1L patie
Slide 10: Blenrep: Data from DREAMM-7, DREAMM-8 and a NDMM study
Blenrep (belantamab mafodotin): Data from DREAMM-7, DREAMM-8 and a NDMM study Dr. Evangelos Terpos, MD, PhD Professor of Haematology, National and Kapodistrian University of Athens, and DREAMM-8 Principal Investigator 10
Slide 11: DREAMM-7 study design
DREAMM-7 study design Recruitment period Treatment period ≈13 months from FPI (May 7, 2020) to LPI Until end of study, withdrawal of consent, PD, death, or Follow-up period (June 28, 2021) unacceptable toxicity Cycles 1-8 Cycle 9+ Belamaf Follow-up for PFS Follow-up for OS Belamaf Arm A (BVd) Eligib
Slide 12: DREAMM-7: BVd led to a significant increase in PFS vs. DVd
DREAMM-7: BVd led to a significant increase in PFS vs. DVd 18 months 1.0 BVd DVd PFSa (N=243) (N=251) 69% 0.8 Events, n (%) 91 (37) 158 (63) Median PFS probability 36.6 PFS, median 0.6 months 36.6 13.4 (95% CI), (28.4-NR) (11.1-17.5) monthsb 0.4 Median HR 0.41 13.4 (95% CI)c (0.31-0.53) 0.2 months B
Slide 13: DREAMM-7: early OS trend favouring BVd vs. DVd
DREAMM-7: early OS trend favouring BVd vs. DVd 12 months 18 months 1.0 87% 84% BVd DVd OSa (N=243) (N=251) 0.8 81% OS probability 73% Events, n (%) 54 (22) 87 (35) 0.6 OS, median (95% CI), NR NR 0.4 monthsb HR 0.57 0.2 (95% CI)c (0.40-0.80) BVd DVd P valued .00049e 0.0 0 1 2 3 4 5 6 7 8 9 10 11 12 1
Slide 14: DREAMM-7: deeper responses with BVd vs. DVd
DREAMM-7: deeper responses with BVd vs. DVda ORR, 82.7% 90 (95% CI, 77.4%-87.3%) ORR, 71.3% 80 (95% CI, 65.3%-76.8%) sCR:14 ≥ CR MRD negativityb 70 sCR: 5.2 ≥ CR: 34.6% ≥ CR: 17.1% Patients, % (95% CI, 28.6%-40.9%) (95% CI, 12.7%-22.4%) 24.7% vs 9.6% 60 CR: 20.6 CR: 12 (95% CI, (95% CI, 19.4%-30.6%)
Slide 15: DREAMM-7: prespecified subgroup analysis of IRC-assessed PFS
DREAMM-7: prespecified subgroup analysis of IRC-assessed PFS BVd DVd Favors BVd Favors DVd Categories n/N n/N HR (95% CI) a HR (95% CI)a All patients (stratified)b 91/243 158/251 0.41 (0.31-0.53) No. of of prior LOT 1 46/125 76/125 0.52 (0.36-0.76) 2 or 3 30/88 62/99 0.34 (0.22-0.53) ≥4 15/30 20/27
Slide 16: DREAMM-7: subgroup by lenalidomide refractory status
DREAMM-7: subgroup by lenalidomide refractory status Progression-free survival (lenalidomide refractory and not refractory) Lenalidomide Refractory Not Lenalidomide Refractorya BVd DVd HRd BVd DVd HRd PFSb PFSb (N=79) (N=87) (95% CI) (N=164) (N=164) (95% CI) Events, n (%) 33 (42) 64 (74) Events, n (
Slide 17: DREAMM-7: subgroup by cytogenetic risk
DREAMM-7: subgroup by cytogenetic risk Progression-free survival (high risk and standard risk) High Risk Standard Risk BVd DVd HRc BVd DVd HRc PFSa PFSa (N=67) (N=69) (95% CI) (N=175) (N=175) (95% CI) Events, n (%) 26 (39) 48 (70) Events, n (%) 65 (37) 106 (61) 0.31 0.44 1.0 mPFS 33.2 10.5 1.0 mPFS
Slide 18: DREAMM-8: study design
DREAMM-8: study design Recruitment period Treatment period Until PD, death, unacceptable toxicity, end of study, or October 2020 to December 2022 withdrawal of consent N=302 Belantamab mafodotin BPd (Q4W) Eligibility criteria 2.5 mg/kg IV (cycle 1) then 1.9 mg/kg IV Q4W from cycle 2 Primary endpoint
Slide 19: DREAMM-8: BPd led to a significant PFS benefit vs. PVd
DREAMM-8: BPd led to a significant PFS benefit vs. PVd PFS BPd (N=155) PVd (N=147) Events, n (%) 62 (40) 80 (54) Proportion alive and progression free 1.0 Median PFS (95% CI), months NR (20.6-NR) 12.7 (9.1-18.5) 12 months HR (95% CI); P value 0.52 (0.37-0.73); <.001 0.8 71% 0.6 0.4 51% 0.2 BPd PVd 0
Slide 20: DREAMM-8: PFS benefit was seen consistently across all prespecified subgroups
DREAMM-8: PFS benefit was seen consistently across all prespecified subgroups Favors BPd Favors PVd BPd PVd Hazard ratio Hazard ratio Categories n/N n/N (95% CI) (95% CI) All patients (stratified)a 62/155 80/147 0.52 (0.37-0.73) Age, years <65 28/64 27/53 0.64 (0.37-1.09) 65 to <75 29/72 34/59 0.48
Slide 21: DREAMM-8: PFS benefit was seen consistently across all prespecified subgroups
DREAMM-8: PFS benefit was seen consistently across all prespecified subgroups Favors BPd Favors PVd BPd PVd Hazard ratio Hazard ratio Categories n/N n/N (95% CI) (95% CI) Prior stem cell transplant Yes 42/99 41/82 0.61 (0.39-0.94) No 20/56 39/65 0.45 (0.26-0.78) Number of prior lines of therapy 1 25
Slide 22: DREAMM-8: deeper responses with BPd vs. PVd
DREAMM-8: deeper responses with BPd vs. PVd 90 ORR: 77% (95% CI, 70%-84%) ORR: 72% 80 (95% CI, 64%-79%) sCR: 9 sCR: 3 70 Patients, % ≥CR: 40% CR: 14 ≥CR: 16% 60 (95% CI, 32%-48%) (95% CI, 11%-23%) CR: 31 50 VGPR: 22 40 ≥VGPR: 64% ≥VGPR: 38% (95% CI, 56%-71%) (95% CI, 30%-46%) 30 VGPR: 24 20 PR: 34 1
Slide 23: DREAMM-8: higher MRD negativity rates with BPd vs. PVd
DREAMM-8: higher MRD negativity rates with BPd vs. PVd 90 80 sCR: 9 sCR: 3 70 MRD negativity: MRD negativity: Patients, % 24% CR: 14 5% 60 (95% CI, 17%-31%) (95% CI, 2%-10%) CR: 31 50 MRD negativity: VGPR: 22 MRD negativity: 40 32% 5% (95% CI, 25%-40%) (95% CI, 2%-10%) 30 VGPR: 24 20 PR: 34 10 PR: 1
Slide 24: DREAMM-8: positive OS trend favouring BPd vs. PVd
DREAMM-8: positive OS trend favouring BPd vs. PVd Interim OS BPd (N=155) PVd (N=147) Events, n (%)a 49 (32) 56 (38) 1.0 12 months Median OS (95% CI), months NR (33.0-NR) NR (25.2-NR) 83% HR (95% CI)b 0.77 (0.53-1.14) 0.8 Proportion alive Subsequent antimyeloma ITT population 76% 0.6 therapy, n (%)c
Slide 25: DREAMM-7: changes in BCVA
DREAMM-7: changes in BCVA 20/20 20/50 20/200 Reprinted from Shi C, et al. bioRxiv. 2018;doi:doi.org/10.1101/328443. Copyright © 2018 the Author. Bilateral worsening of BCVA in patients with normal baseline 20/25 or better BVd 20/50 or worsea 20/200 or worsea Patients, n/N (%) 82/242 (34) 5/242 (2) T
Slide 26: DREAMM-7: impact of dose modifications on PFS and ocular management
DREAMM-7: impact of dose modifications on PFS and ocular managementa % bilateral 20/50 or worse • Median time between doses increased 100 % discontinued due to KVA or 12.0 12.0 13 the longer patients were on therapy CTCAE ocular events 11.3 Patients with occurrence of bilateral 20/50 (or worse), %b
Slide 27: DREAMM-8: bilateral worsening in best corrected visual acuity
DREAMM-8: bilateral worsening in best corrected visual acuity 20/20 20/50 20/200 Reprinted from Shi C, et al. bioRxiv. 2018;doi:doi.org/10.1101/328443. Copyright © 2018 the Author. Bilateral worsening of BCVA in patients with normal baseline (20/25 or better in ≥1 eye) BPd 20/50 or worsea 20/200 or
Slide 28: Blenrep efficacy data is potentially transformational vs. 2L+ SoC triplets
Blenrep efficacy data is potentially transformational vs. 2L+ SoC triplets Independent, H2H confirmation vs. daratumumab and bortezomib with consistent, manageable safety DREAMM-7 DREAMM-8 Safety mPFS 36.6 months mPFS NR • Safety and tolerability of BVd and BPd regimens in DREAMM- (HR 0.41; P<.00001
Slide 29: Study of BRd in 1L MM evaluates optimal dosing and dosing schedules
Study of BRd in 1L MM evaluates optimal dosing and dosing schedules Presented at 5th European Myeloma Network Meeting (April 2024) Part 1 Permitted dose (mg/kg) (36 patients modifications randomized 1:1:1) Key eligibility criteria Belamaf Primary endpoint Cohort 1 Cohort 2 Cohort 3 • Cohort 1: 2.5 m
Slide 30: Clinical activity observed across doses with no disease progression to date
Clinical activity observed across doses with no disease progression to date Overall Response Rate Progression Free Survival 2 (16.7%) 2 (16.7%) 8 (22.2%) 4 (33.3%) 4 (33.3%) 4 (33.3%) 11 (30.6%) PFS Events: 8 deaths Patients (%) 3 (25.0%) • COVID-19: 4 patients; • Pneumonia: 2 patients; • Sudden dea
Slide 31: Low frequency of ≥Gr3 OAEs and meaningful BCVA decline were observed
Low frequency of ≥Gr3 OAEs and meaningful BCVA decline were observed Times to OAE resolution were rapid Frequency in clinically relevant vision impairments 300 Cohort 1 Cohort 2 Cohort 3 (1.4 (2.5 mg/kg) (1.9 mg/kg) mg/kg) Total number of ocular assessments 268 295 241 250 Assessments with ΟΑΕ, n (%
Slide 32: Ocular symptoms had minimal impact on activities of daily living
Ocular symptoms had minimal impact on activities of daily living No patients discontinued due to ocular adverse events Cohort 1 (2.5 mg/kg) Cohort 2 (1.9 mg/kg) Cohort 3 (1.4 mg/kg) Ocular symptoms (Q1-Q5) Activities of daily living (Q6-Q9) All/most/half of the time None/some of the time Non-applica
Slide 33: Appropriate belamaf dose administration critical to avoiding ocular events
Appropriate belamaf dose administration critical to avoiding ocular events Inappropriate dose administration Appropriate dose administration Visual acuity - Snellen chart B B B B B B B B B B B B B B B B B B B B 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 1 2 3 4 5 6 7 8 9
Slide 34: Summary of BRd in 1L multiple myeloma
Summary of BRd in 1L multiple myeloma Dosing and efficacy Dosing and vision-related functioning • Extension of belamaf dosing to Q8W/Q12W did • Extended dosing schedule had only a minimal not lead to reduced efficacy compared to impact on vision-related functioning, with previous studies implementin
Slide 35: Eye-related side effects experienced on Blenrep can be manageable
Eye-related side effects experienced on Blenrep can be manageable 35
Slide 36: Blenrep may have potential to improve upon standard of care in 2L MM
Blenrep may have potential to improve upon standard of care in 2L MM Favourable comparison to standard of care regimens on efficacy, convenience and access Population Regimen lenalidomide exposed PFS ITT Key constraint Treatment visits (%) (months) Start 6 months+ belamaf-Vd1 52 37 - Weekly 6-12 wee
Slide 37: Blenrep may have a role in all patient segments and sites of care in 2L MM
Blenrep may have a role in all patient segments and sites of care in 2L MM Eligibility may span patient age and fitness Young / Fit Patient Age / Fitness Old / Frail sites of care DKd, KPd Current SoC DPd, PVd All (no cardiac nor other comorbidity) sites of care CAR-Ts Academic (hospitalization requ
Slide 38: Multiple datasets support opportunity for Blenrep in 1L (NDMM)
Multiple datasets support opportunity for Blenrep in 1L (NDMM) Blenrep outperforms daratumumab through direct or indirect comparisons Potential evidence for superiority of Blenrep in 1L DREAMM-10 (phase III): Blenrep in 1L multiple myeloma multiple myeloma (newly diagnosed) DREAMM-7 (vs. daratumumab
Slide 39: Ojjaara/Omjjara (momelotinib)
Ojjaara/Omjjara (momelotinib) Only asset demonstrating durable clinical benefit on spleen response, symptoms and anemia for patients with myelofibrosis 39
Slide 40: Myelofibrosis patients with anaemia have poor OS and limited options
Myelofibrosis patients with anaemia have poor OS and limited options ~40% of patients are anaemic at diagnosis, while nearly all become anaemic over time Myelofibrosis market by 20311,2 Significant patient burden3 with Treatment dynamics4,5,6 nearly all patients becoming anaemic over time ~£3bn +7%
Slide 41: Strong Ojjaara launch uptake; establishing share in 1L and 2L settings
Strong Ojjaara launch uptake; establishing share in 1L and 2L settings Ojjaara: fastest US launch uptake in value for a JAKi Strong commercial performance in MF1 • Driven by strong execution 90 • US share in patients with anaemia2: 14% in 1L and 28% in 2L 80 • ~60% of US physicians expect to increas
Slide 42: Zejula (niraparib)
Zejula (niraparib) Continued impact on ovarian cancer outcomes and promising data in glioblastoma 42
Slide 43: Zejula development is mainly focused within ovarian cancer and GBM
Zejula development is mainly focused within ovarian cancer and GBM Ovarian cancer market by 20311,2 Glioblastoma market by 20311,2 Poly (ADP-ribose) polymerase inhibitor (PARPi) class ~£7bn +16% compound growth rate ~£1bn +45% compound growth rate • Established therapy option for platinum-sensitive
Slide 44: Promising data in glioblastoma is a compelling opportunity
Promising data in glioblastoma is a compelling opportunity Zejula crosses the blood-brain barrier to penetrate brain tumours No clinically meaningful improvement in unmethylated Zejula (phase III) in glioblastoma, MGMT population since 1978 Ivy Brain Institute supported collaborative study • Based u
Slide 45: Immuno-oncology: Jemperli (dostarlimab) and CD226 axis assets
Immuno-oncology: Jemperli (dostarlimab) and CD226 axis assets Development of monotherapy and combinations across select solid tumours 45
Slide 46: Jemperli development is focused across endometrial, CRC and HNSCC
Jemperli development is focused across endometrial, CRC and HNSCC dMMR-driven tumour opportunities with expansion into highly PD-L1 positive HNSCC Endometrial cancer market Colorectal cancer market Head and neck cancer market by 20311,2 by 20311,2 by 20311,2 ~£2bn +13% compound growth rate ~£9bn +7%
Slide 47: Jemperli & chemo showed significant OS benefit in 1L endometrial cancer
Jemperli & chemo showed significant OS benefit in 1L endometrial cancer Unprecedented data builds upon current approval in 1L primary advanced/recurrent dMMR population RUBY 1: statistically significant PFS benefit in RUBY 1: statistically significant OS benefit in all- dMMR/MSI-H1 (mPFS NE (30) vs.
Slide 48: Jemperli has shown transformative data in LA dMMR rectal cancer
Jemperli has shown transformative data in LA dMMR rectal cancer Data ungated further investment in registration-enabling gastrointestinal indications Continued benefit in locally AZUR-1 (phase II): Jemperli monotherapy in dMMR rectal cancer advanced dMMR rectal • Current SoC: CRT cancer1 < cCR and/o
Slide 49: Jemperli data shows unprecedented response in locally advanced dMMR rectal cancer
Jemperli data shows unprecedented response in locally advanced dMMR rectal cancer Dr. Andrea Cercek, medical oncologist Memorial Sloan Kettering Cancer Center and Principal Investigator, GSK-supported dostarlimab study in dMMR rectal cancer 49
Slide 50: Jemperli being explored in locally advanced head and neck cancer
Jemperli being explored in locally advanced head and neck cancer Investigating potential as new standard of care in post-chemoradiotherapy setting JADE (phase III): Jemperli monotherapy in HNSCC • PD-(L)1 drug class has shown efficacy improvements over standard of care in the relapsed/metastatic 12
Slide 51: GSK and iTeos initiated phase III GALAXIES Lung-301 study in NSCLC
GSK and iTeos initiated phase III GALAXIES Lung-301 study in NSCLC First registrational study of the Jemperli-belrestotug combination Advancing CD226 axis combinations in NSCLC Compelling science • Fc-functional domain: Preclinical evidence suggests Fc engagement may be important for optimal antitum
Slide 52: Jemperli programme explores monotherapy and combinations
Jemperli programme explores monotherapy and combinations Endometrial cancer foundation with potential for growth across solid tumours Illustrative timeline 2024 2025 2026 2027 2028 RUBY 1 (phase III) Approved in dMMR/MSI-H (2023); 1L EC (+chemo) all-comers indication PDUFA Aug 2024 DOMENICA (phase I
Slide 53: Antibody-drug conjugates (GSK5733584 (B7-H4), GSK5764227 (B7-H3))
Antibody-drug conjugates (GSK5733584 (B7-H4), GSK5764227 (B7-H3)) Blockbuster potential across focused tumour indications 53
Slide 54: GSK5733584 (B7-H4 ADC) builds on presence in gynaecologic cancers
GSK5733584 (B7-H4 ADC) builds on presence in gynaecologic cancers B7-H4 is highly expressed in solid tumours ESMO 2023: HS-20089 showed an ORR of 33.3% with high unmet need (4.8 mg/kg) and 27.3% (5.8mg/kg) in TNBC patients 100% % B7-H4 positive2 80 80% 60 Best change from baseline 60% in target lesi
Slide 55: GSK5764227 (B7-H3) has multi-indication, transformational potential
GSK5764227 (B7-H3) has multi-indication, transformational potential B7-H3 is broadly expressed ASCO 2023: HS-20093 showed an • Clinical activity observed in a broad across numerous tumour types ORR of 63.6% in SCLC patients (N=11) range of tumours, including non-small with high unmet need1 lung canc
Slide 56: Delivering upon our future ambition
Delivering upon our future ambition 56
Slide 57: Select oncology growth drivers
Select oncology growth drivers Ojjaara • Anaemia burden increasingly at GSK5764227 (B7-H3) & • Antigen overexpression in tumours with forefront of treatment decisions GSK5733584 (B7-H4) ADCs high unmet need >£1bn • 56%/66% of US/EU physicians likely to switch to Ojjaara/Omjjara within next 6 Blockbu
Slide 58: Forthcoming catalysts
Forthcoming catalysts Remainder of 2024 2025 2026+ Regulatory filings Regulatory decisions Regulatory decisions US, EU, JP & CHN (2L+ MM) US, EU & JP (2L+ MM) CHN (2L+ MM) Blenrep DREAMM-10 Phase III initiation (1L MM) Regulatory decision Regulatory decision AZUR-1 US (1L EC all-comers) EU (1L EC al
Slide 59: Q&A
Q&A 59
Slide 60: Q&A participants
Q&A participants Luke Miels Dr Tony Wood Dr Evangelos Terpos Chief Commercial Officer Chief Scientific Officer Professor of Haematology National and Kapodistrian University of Athens DREAMM-8 Principal Investigator Dr Nina Mojas Dr Hesham Abdullah Dr Mondher Mahjoubi SVP, Global Product Strategy SVP
Slide 61: Use of GSK conference call, webcast and presentation slides
Use of GSK conference call, webcast and presentation slides The GSK plc webcast, conference call and presentation slides (together the ‘GSK materials’) are for your personal, non-commercial use only. You may not copy, reproduce, republish, post, broadcast, transmit, make available to the public, sel
Slide 62: gsk.com
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