Gsk Plc · LSE:GSK
Gsk — Investor Presentation (December 2019)
37 slides from Gsk's investor presentation, Dec 17, 2019
Slide 1: Accelerating our oncology pipeline: belantamab mafodotin DREAMM-2 data
Accelerating our oncology pipeline: belantamab mafodotin (GSK’916) DREAMM-2 data 17 December 2019
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: Agenda
Agenda Accelerating our oncology Dr Hal Barron pipeline Chief Scientific Officer, President R&D Dr Peter Voorhees Results of DREAMM-2 Director of Outreach for Hematologic Malignancies, Levine Cancer Institute Putting DREAMM-2 in context Dr Axel Hoos SVP, Oncology R&D Commercial ambitions in multiple
Slide 4: Science x Technology x Culture
Strengthening our R&D Science pipeline through a focus on x science related to the immune Technology system, the use of human x genetics, and advanced Culture technologies
Slide 5: Accelerating our oncology pipeline
Accelerating our oncology pipeline 16 assets in development with 3 potential launches in 2020 Mechanism Phase 1 Phase 2 Phase 3 (FTIH) (dose expansion) (pivotal) PARP inhibitor (Zejula, niraparib)* First line maintenance ovarian, other solid tumors under investigation Anti-BCMA immunoconjugate (bela
Slide 6: Belantamab mafodotin (GSK'916): accelerated development plan
Belantamab mafodotin (GSK‘916): accelerated development plan advancing rapidly in multiple myeloma (MM) July 2018 December 2019 – Initiated DREAMM-2 4L monotherapy – DREAMM-2 pivotal data readout pivotal study – Both doses show positive benefit risk in – 1st subject dosed early July heavily pre-trea
Slide 7: Results of DREAMM-2
Results of DREAMM-2 Dr Peter Voorhees Director of Clinical Operations and Outreach for the Department of Hematologic Oncology and Blood Disorders Member, Plasma Cell Disorders Division Levine Cancer Institute, Atrium Health
Slide 8: Trial design
Trial design Patients: 3L+ RRMM Treatment until disease progression or unacceptable toxicity ocular sub-study belantamab mafodotin PRIMARY KEY SECONDARY RANDOMIZE SCREENING Main study & 2.5 mg/kg IV (frozen) Q3W † OUTCOME: OUTCOMES: • ORR: % of • Efficacy: CBR, PFS, OS, 1:1 belantamab mafodotin pati
Slide 9: Baseline demographic and disease characteristics
Baseline demographic and disease characteristics belantamab mafodotin belantamab mafodotin Characteristic 2.5 mg/kg (N=97) 3.4 mg/kg (N=99) Age, median (IQR), years 65 (60–70) 67 (61–72) Sex, n (%) Male 51 (53) 56 (57) Female 46 (47) 43 (43) ISS stage at screening, n (%) I 21 (22) 18 (18) II 33 (34)
Slide 10: Primary endpoint, meaningful ORR with deep responses in both dose groups
Primary endpoint, meaningful ORR with deep responses in both dose groups IRC-assessed response* belantamab mafodotin belantamab mafodotin 2.5 mg/kg (N=97) 3.4 mg/kg (N=99) ORR†, n (%) 30 (31) 34 (34) (97.5% CI) (20.8–42.6) (23.9–46.0) sCR, n (%) 2 (2) 3 (3) CR, n (%) 1 (1) 0 VGPR, n (%) 15 (15) 17 (
Slide 11: Response rates in high-risk patient cohorts were comparable to the overall population
Response rates in high-risk patient cohorts were comparable to the overall patient population 2.5 mg/kg belantamab mafodotin 3.4 mg/kg belantamab mafodotin Categories ORR (%) n/N ORR (%) (CI) Categories ORR (%) n/N ORR (%) (CI) All patients Baseline Normal (≥90) renal Age, year 18 to <65 Impairment,
Slide 12: Median DoR and OS were not reached for responders in either cohort
Median DoR and OS were not reached for responders in either cohort* belantamab mafodotin belantamab mafodotin IRC-assessed outcome (median) 2.5 mg/kg (N=97) 3.4 mg/kg (N=99) OS, months NR‡ NR‡ PFS, months (95% CI) 2.9 (2.1–3.7)† 4.9 (2.3–6.2)† DoR, months NR‡ NR‡ Patients with DoR ≥4 months (% [95%
Slide 13: Median PFS was not reached for responders in either cohort
Median PFS was not reached for responders in either cohort mPFS was 2.9 and 4.9 mos in the 2.5-mg/kg and 3.4-mg/kg groups, not reached in patients with MR or better A. PFS survival by response B. PFS survival by response (belantamab mafodotin 2.5-mg/kg) (belantamab mafodotin 3.4-mg/kg) Post-hoc anal
Slide 14: Safety overview
Safety overview All AE’s of interest and any AE’s >20% in either cohort Belantamab mafodotin Belantamab mafodotin Number of patients with event (safety 2.5 mg/kg (N=95) 3.4 mg/kg (N=99) population), n (%)* Grade 1-2 Grade 3 Grade 4 Grade 5 Grade 1-2 Grade 3 Grade 4 Grade 5 Keratopathy or corneal epi
Slide 15: Adverse event-related dose reductions and delays were less frequent in 2.5 mg/kg
Adverse event-related dose reductions and delays were less frequent in 2.5 mg/kg vs 3.4 mg/kg group Number of patients with event (%) belantamab mafodotin belantamab mafodotin (safety population) 2.5 mg/kg (N=95) 3.4 mg/kg (N=99) Any adverse event (AE) 93 (98) 99 (100) AEs leading to permanent treat
Slide 16: Keratopathy though common, led to few discontinuations
Keratopathy though common, led to few discontinuations • Keratopathy led to dose reduction in 23% and 27% of patients and dose delays in 47% and 48% of the patients in the 2.5-mg/kg and 3.4-mg/kg groups, respectively. • Among patients with treatment delays due to keratopathy in the 2.5-mg/kg and 3.4
Slide 17: Corneal event management protocol
Corneal event management protocol • The nature of corneal events reported in DREAMM-2 is not uncommon for immunoconjugates, which use MMAF or other microtubule-targeting cytotoxins. • Exact mechanism for onset of these events is unknown, might be related to non-specific uptake of ADC into actively d
Slide 18: DREAMM-2 data published in the Lancet Oncology
DREAMM-2 data published in the Lancet Oncology In DREAMM-2 belantamab mafodotin provided a clinically meaningful response rate for heavily pretreated patients with RRMM with limited treatment options Single-agent belantamab mafodotin (2.5 mg/kg and 3.4 mg/kg Q3W) demonstrated: • Deep and durable res
Slide 19: Putting DREAMM-2 in context
Putting DREAMM-2 in context Dr Axel Hoos, SVP Oncology R&D
Slide 20: Belantamab mafodotin: critical features
Belantamab mafodotin: critical features • First BCMA-targeted agent in multiple myeloma • DREAMM-2 demonstrated deep and durable responses in a heavily pre-treated patient population including those who were refractory to an anti-CD38 antibody • Treatment-related corneal events were manageable with
Slide 21: DREAMM-2 results in-line with expectations based on DREAMM-1 subpopulation
DREAMM-2 results in-line with expectations based on DREAMM-1 subpopulation DREAMM-1 subpopulation DREAMM-2 overall population: DREAMM-1 overall population: Refractory to immunomodulatory Refractory to immunomodulatory Refractory to immunomodulatory Prior treatment drugs, proteasome inhibitors, and d
Slide 22: Dose selection based on benefit / risk
Dose selection based on benefit / risk Single-agent belantamab mafodotin based on DREAMM-2 data DREAMM-2 was not designed to compare belantamab mafodotin doses or address non-inferiority; comparisons were made for exploratory purposes belantamab mafodotin belantamab mafodotin Efficacy (intention-to-
Slide 23: Post-daratumumab approval: differentiated response in highly refractory patients
Belantamab mafodotin demonstrated differentiated response in highly refractory patients Increasingly refractory patient RRMM clinical data populations (indirect comparison) (indirect comparison) belantamab Agent mafodotin Regimen 2.5 mg/kg Q3W +Dex +Dex +Dex mLoT Post-daratumumab approval 5 5 5 8 7
Slide 24: Four upcoming pivotal study starts across 3L, 2L and 1L multiple myeloma
Four upcoming pivotal study starts across 3L, 2L and 1L multiple myeloma (MM) Development strategy for use in: Study start Est launch relapsed/ Belantamab mafodotin monotherapy, DREAMM-1 pilot 2014 --- refractory patients single arm, n=73 Belantamab mafodotin monotherapy, DREAMM-2 pivotal daratumuma
Slide 25: Unique features of different BCMA targeting modalities
Unique features of different BCMA targeting modalities ADC/ CAR-T Bispecific immuno-conjugate Most advanced development Registrational Phase 3 Phase 1 stage Commercial scalability Dosing/administration 30 minutes, Q3W 1 One off administration ~1-2 hours, QW-Q2W Hospitalisation More data needed5,6 Ly
Slide 26: Belantamab mafodotin: critical features
Belantamab mafodotin: critical features • First BCMA-targeted agent in multiple myeloma • DREAMM-2 demonstrated deep and durable responses in a heavily pre-treated patient population including those who were refractory to an anti-CD38 antibody • Treatment-related corneal events were manageable with
Slide 27: Commercial ambitions in multiple myeloma
Commercial ambitions in multiple myeloma Luke Miels, President Global Pharmaceuticals
Slide 28: Multiple myeloma is the 2nd most common haematological malignancy with high unmet need
Multiple myeloma (MM) is the 2nd most common haematological malignancy with high unmet need, despite new treatments Drug treated Patients 2019 • High incidence rates: >160K cases / year (US, EU5, JP) 65K globally • High relapse rates: 40% of patients progress to 3L+ 41K • Low survival: ~52% five-yea
Slide 29: Growing market with opportunity for more durable, innovative agents
Growing market with opportunity for more durable, innovative agents Market value ~$19bn in 2019, MM global drug market share (2019 estimated) estimated to grow ~7% CAGR reaching ~$24bn by 2023 2% 6% Immuno- modulatory agents 13% Key drivers of growth: Anti-CD38 • Aging population – increasing incide
Slide 30: Building our oncology commercial capability
Building our oncology commercial capability Improved engagement with HCPs 3 potential oncology launches in 2020 Updated HCP engagement policies to improve how we Zejula (PARP inhibitor) 1L ovarian cancer maintenance help prescribers understand new data and clinical therapy (PRIMA) presented at ESMO
Slide 31: Q&A
do more feel better live longer Q&A
Slide 32: Dr Hal Barron
Dr Hal Barron Hal joined GSK as Chief Scientific Officer and President, R&D on 1 January 2018. He is a member of the Board and the Corporate Executive Team. His previous role was President, R&D at Calico (California Life Company). Prior to this, Hal was Executive Vice President, Head of Global Produ
Slide 33: Dr Peter Voorhees
Dr Peter Voorhees Dr. Peter Voorhees trained as a Hematology-Oncology Fellow at the University of North Carolina from 2001 – 2004 where he first developed an interest in multiple myeloma. He subsequently joined the faculty at UNC and became the head of their Multiple Myeloma Program in 2007. In the
Slide 34: Dr Axel Hoos
Dr Axel Hoos Axel is SVP, R&D Governance Chair, and Therapeutic Area (TA) Head for Oncology at GSK, responsible for discovery and development in Oncology. As R&D governance chair he oversees technical and funding review committees. Axel also serves as Chairman of the Board of Trustees of the Sabin V
Slide 35: Luke Miels
Luke Miels Luke joined GSK as President, Global Pharmaceuticals in September 2017. He is a member of the Corporate Executive Team. At GSK, he is responsible for commercialising a portfolio of medicines and vaccines with annual sales of more than £20 billion and operations in over 100 markets. His pr
Slide 36: Christine Roth
Christine Roth Christine re-joined GSK as SVP, Global Oncology Therapy Area Head in December 2017, reporting to Luke Miels. As the global commercial lead for oncology, Christine is a member of the Pharmaceutical Leadership Team, Forecast Review Committee, Research Investment Board, Development Revie
Slide 37: Ira Gupta
Ira Gupta Ira re-joined GSK as VP, Medicines Development Leader – belantamab mafodotin, Global Oncology Therapy Area Head in January 2018. As the Medicine Development Leader, Ira has the ‘Single Point of Accountability’ for belantamab mafodotin and she leads a cross-discipline Medicine Development T