Gsk Plc · LSE:GSK

Gsk — ASCO Investor Meeting June 2012

18 slides from Gsk's conference presentation, June 2012

  1. Slide 1: ASCO Analyst Presentation

    ASCO Analyst Presentation Paolo Paoletti, MD President, GSK Oncology

  2. Slide 2: GSK Oncology

    GSK Oncology 2005 Today • No dedicated • Globally integrated research, development and clinical oncologists commercial organization • No dedicated • Presence in over 70 countries, with oncology clinical operations focused business units in top 12 markets support • Over 1300 staff, including 60 full-

  3. Slide 3: Our Growth

    Our Growth £m 700 600 500 Mature Products 400 Growth 300 Products 200 GSK Oncology in Q1 2012 was £179M + 22% CER 100 0 2007 2008 2009 2010 2011 3

  4. Slide 4: GSK Oncology – Key approved and future indications

    GSK Oncology – Key approved and future indications Product Approved Indications Future Indications • ALL • CLL 1L & Relapse & Maintenance • Refractory CLL • DLBCL Relapse • FL Relapse / Refractory • ITP • HEP C Liver • MDS / AML • Breast Dual Blockade • Breast HER2+ Refractory • GI • 1L Combination

  5. Slide 5: Scientific innovation through Discovery Performance Units

    Scientific innovation through Discovery Performance Units Metabolism Epitope Combinations/Kinase Protein Dynamics Epigenetics 5

  6. Slide 6: Dabrafenib and Trametinib: Data from ASCO 2012

    Dabrafenib and Trametinib: Data from ASCO 2012

  7. Slide 7: METRIC – Progression-Free Survival

    METRIC PFS – Primary Efficacy Population 1.0 Events Median HR (95%CI) n (%) (months) P-value 0.9 Proportion Alive and Progression-Free Trametinib 96 (54) 4.8 0.44 (0.31, 0.64) <0.0001 0.8 Chemotherapy 68 (72) 1.4 0.7 0.6 0.5 0.4 0.3 INV – Trametinib 0.2 IRC – Trametinib 0.1 INV – Chemotherapy IRC –

  8. Slide 8: METRIC – Overall Survival

    METRIC Overall Survival – ITT 1.0 0.9 0.8 0.7 Proportion Alive 0.6 0.5 0.4 0.3 Events, Median HR (95% CI) 6 Month OS 0.2 n (%) (months) P-value (95% CI) Trametinib 35 (16) -- 0.54 (0.32, 0.92) 81 (73, 86) 0.1 0.0136 Chemotherapy 29 (27) -- 67 (55, 77) 0.0 0 1 2 3 4 5 6 7 8 9 10 Time From Randomizati

  9. Slide 9: METRIC – Adverse Events (>15%)

    METRIC – Adverse Events (>15%) Preferred Term (>15% of subjects) Trametinib Chemotherapy n=211 n=99 Rash 121 (57%) 10 (10%) Diarrhoea 91 (43%) 16 (16%) Oedema peripheral 54 (26%) 3 (3%) Fatigue 54 (26%) 27 (27%) Dermatitis acneiform 40 (19%) 1 (1%) Nausea 38 (18%) 37 (37%) Alopecia 36 (17%) 19 (19%)

  10. Slide 10: BREAK-3 Primary endpoint: PFS

    BREAK3 Primary endpoint: PFS Investigator-assessed (cut-off: 19 December 2011) Hazard ratio 0.30 (95% CI: 0.18, 0.51); p<0.0001 1.0 Proportion Alive Without Progression 0.9 0.8 Dabrafenib: 0.7 median PFS 5.1 mos 0.6 0.5 0.4 DTIC: 0.3 median PFS 2.7 mos 0.2 0.1 0.0 0 1 2 3 4 5 6 7 8 9 Time from Rando

  11. Slide 11: BREAK 3 treatment-related AEs (≥ 5%)

    BREAK 3 treatment-related AEs (≥ 5%) Dabrafenib, n (%) DTIC, n (%) AE All Grade 3 Grade 4 All Grade 3 Grade 4 Hyperkeratosis 95 (51) 1 (<1) 1 (<1) – – – Palmar-plantar Skin 39 (21) 4 (2) – 1 (2) – – hyperkeratosis SCC/KA 13 (7) 9 (5) – – – – Nausea 18 (10) – – 21 (36) – – GI Vomiting 8 (4) – – 12 (2

  12. Slide 12: BREAK MB Overall Intracranial Response Rate

    BREAK MB Overall Intracranial Response Rate V600E Number of patients (%) No prior brain Prior brain treatment treatment (n=74) (n=65) OIRR (CR+PR) 29 (39) 20 (31) Intracranial response CR 2 (3) 0 PR 27 (36) 20 (31) SD 31 (42) 38 (58) PD 9 (12) 5 (8) Not evaluable 5 (7) 2 (3) Intracranial disease con

  13. Slide 13: Gadolinium-enhanced T1-weighted MRI images illustrating tumor reduction

    Gadolinium-enhanced T1-weighted MRI images illustrating tumor reduction Baseline Week 32 13

  14. Slide 14: BREAK MB Serious adverse events (≥ 2%)

    BREAK MB Serious adverse events (≥ 2%) No prior brain Prior brain treatment treatment Total (n = 89) (n = 83) (N = 172) Any event 22 (25) 29 (35) 51 (30) Pyrexia 3 (3) 7 (8) 10 (6) Cutaneous squamous cell carcinoma 5 (6) 4 (5) 9 (5) Intracranial hemorrhage 4 (4) 4 (5) 8 (5) Headache 2 (2) 2 (2) 4 (2

  15. Slide 15: BRF113220 Best Confirmed Response Rate

    BRF113220 Best Confirmed Response Rate Part B BRAFi-naïve melanoma patients(N=77) Median duration of response 11.3 mos (95% CI: 9.2, NR) CR+PR CR+PR+SD 100 Response rate, % 80 67% 64% 63% 57% 60 44% 40 18% CR 20 8% CR 8% CR 0 75/1 150/1 150/1.5 150/2 All doses (n=6) (n=22) (n=25) (n=24) (n=77) Dose-

  16. Slide 16: BRF113220 Treatment-Related AEs ≥ 20% of Patients

    BRF113220 Treatment-Related AEs ≥ 20% of Patients 4 dose levels dabrafenib/trametinib (mg BID/mg QD) – 75/1, 150/1, 150/1.5, 150/2 Full dose (n = 79) All Part B (150 mg BID dabrafenib/2 mg QD trametinib) Patients Preferred Term (N = 135) Grade ≥ 3 All grade n (%) n (%) n (%) Any event, n (%) 28 (35)

  17. Slide 17: Key Treatment-Related Skin Toxicities

    Key Treatment-Related Skin Toxicities All Part B Patients (N = 135) Grade ≥ 3, Any grade event, n (%) n (%) Rash/Skin 3 (2%) 61(45%) toxicities1 Skin papilloma 0 (0%) 3 (2%) Squamous cell 4 (3%) 4 (3%) carcinoma Actinic keratosis 0 (0%) 7 (5%) Hyperkeratosis 0 (0%) 5 (4%) 1Skin toxicities include mu

  18. Slide 18: GlaxoSmithKline Oncology

    GlaxoSmithKline Oncology

GSK — ASCO Investor Meeting June 2012 on 6ix