Gsk Plc · LSE:GSK
Gsk — Technical Presentation (December 2017)
20 slides from Gsk's technical presentation, Dec 12, 2017
Slide 1: GSK '916: anti-BCMA ADC
GSK ‘916: anti-BCMA ADC An exciting potential advance in the treatment of Multiple Myeloma 12 December 2017
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 Multiple Myeloma market Luke Miels President, Global Pharmaceuticals ‘916, a priority asset in GSK oncology pipeline Presentation Q&A Axel Hoos, MD, PhD SVP and Head of Oncology Therapy Area 20-25 mins 20-25 mins Results of DREAMM-1 study Paul Richardson, MD Medical Oncology, Dana Farber Canc
Slide 4: Developing the pipeline in Pharma
Developing the pipeline in Pharma Development capital focus on 2 core and 2 potential therapy areas Capital Therapy Areas Prioritised assets Respiratory Trelegy (closed triple) PI3Kδ danirixin HIV/ Juluca (DTG+rilpivirine) Infectious diseases DTG+lamivudine cabotegravir + rilpivirine 80% Immuno- tap
Slide 5: Multiple Myeloma: an incurable hematologic malignancy with high unmet need
Multiple Myeloma (MM): An incurable hematologic malignancy with high unmet medical need, despite new treatments Disease background 5-year survival data (most recent survival data available: - Second most common blood cancer does not reflect most recent innovations) - Myeloma affects major organs of
Slide 6: Market growth creates opportunity for innovation
Market growth creates opportunity for innovation Key Drivers of Growth - Aging population – increasing incidence - Longer duration of therapy, multiple lines Market value ~$12bn in 2016, - Innovation +40% vs 2015 - Efficacy remains key driver of acceptance of new agents - Darzalex‡ (daratumumb anti-
Slide 7: Fragmented treatment paradigm
Fragmented treatment paradigm* Opportunity for new entrants 1st Line patients 1st Line therapy (followed by maintenance) needing therapy • Velcade‡ / Revlimid‡ (Thalomid‡) / Dex based regimens (SoC); • VelRevDex‡ preferred (US); Transplant-Ineligible (TI) Transplant-Eligible (TE) • VelMelPrednisone‡
Slide 8: Oncology R&D
Oncology R&D Maximising survival through transformational medicines and combinations Immuno-Oncology Cell & Gene Therapy Cancer Epigenetics GSK pipeline Reprogram cancer Long-term survival First-in-class medicines cells Combination therapy & cures Stimulate anti-tumour immunity Cells as medicines 8
Slide 9: Innovative & emerging oncology pipeline
Innovative & emerging oncology pipeline BCMA is the lead asset Mechanism Pre-clinical Phase I Phase II Immuno-Oncology BCMA ADC (GSK 2857916) † Heme malignancies ICOS agonist (GSK3359609) † Solid tumours OX40 agonist (GSK3174998) † Solid and heme malignancies TLR4 agonist (GSK1795091) Cancer Novel s
Slide 10: First-in-class anti-BCMA agent with multiple modes of action
First-in-class anti-BCMA agent with multiple modes of action The – GSK’916 is a humanised IgG1 antibody Four mechanisms of action: agent targeting BCMA (B-cell maturation antigen) 1. ADC mechanism 2. ADCC mechanism – Linked to the anti-mitotic agent MMAF 3. BCMA receptor signaling inhibition – Afuco
Slide 11: DREAMM-1: study design
DREAMM-1: study design DRiving Excellence in Approaches to Multiple Myeloma - Patients enrolled regardless of BCMA expression levels - No dose limiting toxicities observed in dose finding phase - 38 patients with relapsed/refractory multiple myeloma - Expansion phase: - Cohort 1: relapsed/refractory
Slide 12: DREAMM-1 Part 2: Demographics and baseline characteristics
DREAMM-1 Part 2: Demographics and baseline characteristics Characteristic Part 2 (N=35) Age (years), median (min, max) 60 (46–75) Females/males, % 51/49 ≥5 prior lines, n (%) 20 (57) ASCT 31 (89) IMiDs, n (%) 35 (100) Lenalidomide 33 (94) Pomalidomide 21 (60) Thalidomide 12 (34) Refractory to IMiD 3
Slide 13: Transformational efficacy in multiple myeloma: ORR
Transformational efficacy in multiple myeloma: ORR Transformational efficacy in refractory populations Overall ORR = 60% 95%CI (42.1%,76.1%); n=35 Patients refractory to IMID and PI (n=31) ORR=58% [95%CI (39.1%,75.5%)] Patients previously treated with daratumumab (n=14) ORR=43% [95%CI (17.7%,71.1%)]
Slide 14: DREAMM-1 Part 2: Response characteristics
DREAMM-1 Part 2: Response characteristics Response characteristics: – Early response seen after 1-2 doses – Mostly durable – Dose reductions did not lead to loss of response CR, complete response; PD, progressive disease; PR, partial response; sCR, stringent complete response; VGPR, very good partia
Slide 15: DREAMM-1 Part 2: Efficacy – progression-free survival and duration of response
DREAMM-1 Part 2: Efficacy – progression-free survival and duration of response Progression free survival Duration of response Number of subjects 35 Number of subjects 21 Progressed or died 15 (43%) Progressed or died 4 (19%) Censored, f/u ended 3 (9%) Censored, f/u ended 0 Censored, f/u ongoing 17 (
Slide 16: Manageable safety profile - summary
Manageable safety profile - summary Most frequent adverse events • Corneal events 63% • Thrombocytopenia 49% Corneal events - mostly low grade (9% G3) • Manageable with steroid eye drops • Dose reductions Hematologic AEs (including thrombocytopenia) • Frequent in MM population due to disease Infusio
Slide 17: GSK'916 single agent has transformational efficacy
GSK’916 single agent has transformational efficacy Drug, Sponsor Line of Therapy; Trial ORR mPFS mOS 1Kyprolis‡ (IV), monotherapy 3L+, Single arm, N=266 23.7% 3.7m 15.6m Amgen 2Darzalex‡ (IV), monotherapy 4L+, Single arm, N=106 29.2% 3.7m 17.5m Janssen 7.9m 5 median lines (40% Darzalex‡ 60% GSK’916
Slide 18: GSK '916: expected next steps
GSK ’916: expected next steps Breakthrough therapy designation from FDA EMA granted PRIME designation Orphan drug designation from the EMA and FDA for multiple myeloma 2018 2019 2020 + Monotherapy in Pivotal phase 2 start: 4th line Pivotal data readout 4th line Filing & launch Multiple Myeloma Combi
Slide 19: Right of first negotiation for GSK oncology assets
Right of first negotiation for GSK oncology assets Novartis has a right of first negotiation (ROFN) that is triggered upon our decision to seek a partner or divest certain oncology assets or if we propose to seek a marketing authorization for such oncology assets, on an asset by asset basis. NVS doe
Slide 20: Q&A
do more feel better live longer &A 20