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Roche — Technical Presentation (2019)

19 slides from Roche's technical presentation, 2019

  1. Slide 1: IMpower110: Interim OS Analysis of a Phase III Study of Atezolizumab vs Chemotherapy

    IMpower110: Interim OS Analysis of a Phase III Study of Atezolizumab (atezo) vs Platinum-Based Chemotherapy (chemo) as 1L Treatment (tx) in PD-L1–selected NSCLC David R Spigel,1 Filippo De Marinis,2 Giuseppe Giaccone,3 Niels Reinmuth,4 Alain Vergnenegre,5 Carlos Henrique Barrios,6 Masahiro Morise,7

  2. Slide 2: Disclosures

    Disclosures  Dr David R Spigel has the following financial relationships to disclose: − Leadership • Centennial Medical Center (BOT) − Consulting or advisory role (payments to institution) • Genentech/Roche, Novartis, Celgene, Bristol-Myers Squib, Astra-Zeneca, Pfizer, Boehringer Ingelheim, Abbvie,

  3. Slide 3: Acknowledgements

    Acknowledgements  The patients and their families  The investigators and clinical study sites − Countries: Brazil, China, France, Germany, Greece, Hungary, Italy, Japan, Republic of Korea, Poland, Romania, Russian Federation, Serbia, Spain, Thailand, Turkey, Ukraine, UK, USA  This study is sponso

  4. Slide 4: Background

    Background  Anti–PD-1 monotherapy or PD-L1/PD-1 inhibitors in combination with platinum-based doublet chemotherapy, with or without bevacizumab, are 1L standards of care in metastatic NSCLC1,2 − Tumour PD-L1 expression level and histology are used to determine treatment regimens  In the Phase II B

  5. Slide 5: IMpower110 Study Design

    IMpower110 Study Design Maintenance therapy (no crossover permitted) Chemotherapy-naive, PD-L1–selecteda Arm A PD or loss patients with stage IV Atezolizumab Survival follow-up Atezolizumab of clinical 1200 mg q3w nsq or sq NSCLC 1200 mg q3w benefit Stratification factors R • Sex 1:1 Arm B • ECOG PS

  6. Slide 6: Statistical Testing Plan

    Statistical Testing Plan Arm A vs Arm B  The primary OS endpoint was tested OS IA in TC3 or IC3 WT hierarchically in the following order: n = 205 TC3 or IC3 WT  TC2/3 or IC2/3 WT  TC1/2/3 or IC1/2/3 WT Arm A vs Arm B  The secondary endpoint of PFS can be OS IA in TC2/3 or IC2/3 WT formally teste

  7. Slide 7: Baseline Characteristics

    Baseline Characteristics Characteristic TC1/2/3 or IC1/2/3 WT TC3 or IC3 WT Arm A (atezo) Arm B (chemo) Arm A (atezo) Arm B (chemo) n (%) n = 277 n = 277 n = 107 n = 98 Age < 65 y 143 (51.6) 134 (48.4) 59 (55.1) 43 (43.9) Male 196 (70.8) 193 (69.7) 79 (73.8) 64 (65.3) White 227 (81.9) 240 (86.6) 87

  8. Slide 8: Prevalence of PD-L1 Expression

    Prevalence of PD-L1 Expressiona Arm A (atezo) Arm B (chemo) 100 100.0% 100.0% 90 80 Prevalence (%) 70 60 59.9% 58.5% 50 40 38.6% 35.4% 30 20 10 n = 107 n = 98 n = 166 n = 162 n = 277 n = 277 0 TC3 or IC3 WT TC2/3 or IC2/3 WT TC1/2/3 or IC1/2/3 WT ≥ 50% TC or ≥ 10% IC ≥ 5% TC or IC ≥ 1% TC or IC a PD

  9. Slide 9: OS: WT

    OS: TC3 or IC3 WT Arm A (atezo) Arm B (chemo) Landmark n = 107 n = 98 6-mo OS 76.3 70.1 (95% CI), % (68.2, 84.4) (60.8, 79.4) 12-mo OS 64.9 50.6 (95% CI), % (55.4, 74.4) (40.0, 61.3) HR,a 0.59 (95% CI: 0.40, 0.89); P = 0.0106b Median follow-up, 15.7 mo (range, 0-35) Median OS, 13.1 mo Median OS, 20.

  10. Slide 10: WT: OS in Key Subgroups

    TC3 or IC3 WT: OS in Key Subgroups a The 1 patient in the ≥ 85 years subgroup is not included; 1 patient’s race was unknown. b Unstratified. c Stratified. Spigel et al. IMpower110 Interim OS Analysis Data cutoff: 10 September 2018. https://bit.ly/2lxRNHQ 10

  11. Slide 11: OS: TC2/3 or IC2/3 WT

    OS: TC2/3 or IC2/3 WT Arm A (atezo) Arm B (chemo) Landmark n = 166 n = 162 6-mo OS 79.3 76.1 (95% CI), % (73.1, 85.5) (69.3, 82.8) 12-mo OS 60.7 56.0 (95% CI), % (52.6, 68.7) (47.7, 64.3) HR,a 0.72 (95% CI: 0.52, 0.99); P = 0.0416b,c Median follow-up, 15.2 mo (range, 0-35) Median OS, 14.9 mo Median

  12. Slide 12: OS: TC1/2/3 or IC1/2/3 WT

    OS: TC1/2/3 or IC1/2/3 WT Arm A (atezo) Arm B (chemo) Landmark n = 277 n = 277 6-mo OS 76.2 75.7 (95% CI), % (71.1, 81.3) (70.5, 80.9) 12-mo OS 57.6 54.3 (95% CI), % (51.2, 64.0) (47.7, 60.8) HR,a 0.83 (95% CI: 0.65, 1.07); P = 0.1481b,c Median follow-up, 13.4 mo (range, 0-35) Median OS, 14.1 mo Med

  13. Slide 13: Subsequent Cancer Therapies

    Subsequent Cancer Therapies TC1/2/3 or IC1/2/3 WT Arm A (atezo) Arm B (chemo) n = 277 n = 277 Patients with ≥ 1 therapy, n (%) 82 (29.6) 137 (49.5) Chemotherapy 77 (27.8) 68 (24.5) Immunotherapy 7 (2.5) 80 (28.9) Targeted therapy 14 (5.1) 12 (4.3)  The proportion of patients who received different

  14. Slide 14: PFS: WT

    PFSa: TC3 or IC3 WT Arm A (atezo) Arm B (chemo) Landmark n = 107 n = 98 6-mo PFS 59.8 38.3 (95% CI), % (50.4, 69.2) (28.5, 48.1) Median PFS, 5.0 mo 12-mo PFS 36.9 21.6 (95% CI: 4.2, 5.7) (95% CI), % (27.0, 46.9) (12.6, 30.6) Median PFS, 8.1 mo HR,b 0.63 (95% CI: 0.45, 0.88); P = 0.0070c,d (95% CI: 6

  15. Slide 15: PFS: TC2/3 or IC2/3 and TC1/2/3 or IC1/2/3 WT

    PFSa: TC2/3 or IC2/3 and TC1/2/3 or IC1/2/3 WT TC2/3 or IC2/3 WT TC1/2/3 or IC1/2/3 WT HR,b 0.67 (95% CI: 0.52, 0.88); P = 0.0030c,d HR,b 0.77 (95% CI: 0.63, 0.94); P = 0.0104c,d Median PFS, 5.5 mo Median PFS, 5.5 mo (95% CI: 4.4, 5.7) (95% CI: 4.6, 5.7) Median PFS, 7.2 mo Median PFS, 5.7 mo (95% CI

  16. Slide 16: Confirmed ORR and DOR

    Confirmed ORR and DOR TC3 or IC3 WT PR CR 60 Arm A (atezo) Arm A (atezo) Arm B (chemo) Arm B (chemo) 50 38.3% TC2/3 or IC2/3 WT n = 166 n = 162 30.7 32.1 28.6% ORR (95% CI), % Response (%) 40 (23.8, 38.3) (25.0, 39.9) Median DOR NE 5.8 30 (range), mo (1.8+ to 29.3+) (2.6 to 23.9+) TC1/2/3 or IC1/2/3

  17. Slide 17: Safety Summary

    Safety Summary Arm A (atezo) Arm B (chemo) n = 286 n = 263 5.3 Pem Gem Carb Cis Median treatment duration (min-max), mo (0-33) 3.5 (0-20) 2.6 (0-5) 2.3 (0-5) 2.1 (0-5) Any-cause AE, n (%) 258 (90.2) 249 (94.7) Related AE 173 (60.5) 224 (85.2) Grade 3-4 AE, n (%) 91 (31.8) 141 (53.6) Related Grade 3-

  18. Slide 18: All-Cause AEs

    ALL-CAUSE AES > 5% difference between arms Arm A (atezo) Arm B (chemo) n = 286 n = 263 Anaemia Nausea Neutropenia More Frequent With Chemo Constipation Thrombocytopenia Vomiting Increased blood creatinine Decreased platelet count Leukopenia Decreased neutrophil count More Frequent Increased AST With

  19. Slide 19: Conclusions

    Conclusions  Atezolizumab monotherapy showed statistically significant and clinically meaningful OS improvement in the TC3 or IC3 WT population vs platinum-based chemotherapy (HR, 0.59 [95% CI: 0.40, 0.89]; P = 0.0106)  The OS testing boundary was not crossed in the TC2/3 or IC2/3 WT population. T

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