Roche Holding Ltd · SIX:RO

Roche — ESMO Immuno-Oncology Congress 2019

18 slides from Roche's conference presentation, 2019

  1. Slide 1: Clinical Efficacy of Atezolizumab in Biomarker Subgroups: IMpower110

    Clinical Efficacy of Atezolizumab in Biomarker Subgroups by SP142, SP263 and 22C3 PD-L1 Immunohistochemistry Assays and by Blood Tumour Mutational Burden: Results From the IMpower110 Study Roy S. Herbst,1 Filippo De Marinis,2 Giuseppe Giaccone,3 Niels Reinmuth,4 Alain Vergnenegre,5 Carlos Henrique B

  2. Slide 2: Disclosures

    Disclosures • Dr Herbst has the following financial relationships to disclose: Consulting: AbbVie Pharmaceuticals, ARMO BioSciences, AstraZeneca, Biodesix, Bolt Biotherapeutics, Bristol-Myers Squibb, Eli Lilly and Company, EMD Serono, Roche/Genentech, Genmab, Halozyme Therapeutics, Heat Biologics, I

  3. Slide 3: Acknowledgements

    Acknowledgements • All patients and their families • Participating study investigators and clinical 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

  4. Slide 4: Background

    Background • In NSCLC, biomarkers that predict response to checkpoint inhibitors remain a key interest • The Phase III IMpower110 study (NCT02409342) is evaluating the efficacy and safety of atezolizumab monotherapy vs platinum-based chemotherapy in PD-L1–selected, chemotherapy-naive patients with m

  5. Slide 5: Background: PD-L1 IHC Assays

    Background: PD-L1 IHC Assays • Numerous PD-L1 IHC assays are routinely used in NSCLC treatment decisions • Dako 22C3 and Ventana SP263: assess PD-L1 tumour cell (TC) expression only; analytically highly concordant assays • Ventana SP142: assesses both PD-L1 TC and immune cell (IC) expression • SP142

  6. Slide 6: IMpower110 Study Design

    IMpower110 Study Design Maintenance therapy (no crossover permitted) Chemotherapy-naive, PD-L1–selected PD or (≥ 1% TC or IC; SP142) Arm A Survival follow-up Atezolizumab loss of patients with stage IV Atezolizumab 1200 mg q3w clinical nsq or sq NSCLC 1200 mg q3w benefit Stratification factors R •Se

  7. Slide 7: Prevalence of PD-L1 Expression in IMpower110

    Prevalencea of PD-L1 Expression in IMpower110 100% 100 80 77% 78% Prevalence (%) 60 59% 54% 49% 40 37% 20 n = 293 n = 422 n = 260 n = 414 n = 205 n = 328 n = 554 0 TC ≥ 50% TC ≥ 1% TPS ≥ 50% TPS ≥ 1% TC3 or IC3 TC2/3 TC1/2/3 or IC2/3 or IC1/2/3 SP263 22C3 SP142 (BEP-WT, n = 546) (BEP-WT, n = 534) (B

  8. Slide 8: Overlap Between PD-L1–High Subgroups in IMpower110

    Overlap Between PD-L1–High Subgroups in IMpower110 22C3 SP263 22C3 SP142 ≥ 50% TPS ≥ 50% TC ≥ 50% TPS TC3 or IC3 4% 45% 8% 20% 44.9% 28% 9% n = 20 n = 238 n = 44 n = 108 n =n238 = 152 n = 46 • High overlap between 22C3 and SP263 was seen in the ≥ 50% subgroup • A large portion of the SP142 TC3 or IC

  9. Slide 9: Baseline Characteristics in the PD-L1 IHC BEP-WT in IMpower110

    Baseline Characteristics in the PD-L1 IHC BEP-WT in IMpower110 TC1/2/3 or IC1/2/3-WT 22C3 BEP-WT SP263 BEP-WT Characteristic (n = 554) (n = 534) (n = 546) Median age (range), y 64 (30-87) 65 (30-87) 64 (30-87) Male, n (%) 389 (70) 372 (70) 383 (70) ECOG PS 0, n (%) 199 (36) 193 (36) 198 (36) Current

  10. Slide 10: OS in PD-L1–High Subgroups in IMpower110

    OS in PD-L1–High Subgroups in IMpower110 SP142;(TC3 SP142 TC3 oror IC3-WT)a IC3-WT 22C3 22C3; BEP-WT (TPS ≥ 50%)a TPS ≥50%-WT SP263 BEP-WT (TC SP263; TC ≥ 50%)a ≥50%-WT 100 Atezolizumab 100 Atezolizumab 100 Atezolizumab Chemotherapy Chemotherapy Chemotherapy 90 90 90 80 80 80 Overall Survival (%) Ov

  11. Slide 11: OS in PD-L1–Positive Subgroups in IMpower110

    OS in PD-L1–Positive Subgroups in IMpower110 SP142; SP142 or IC1/2/3-WT)a TC3 or IC3-WT (TC1/2/3 22C3 22C3; BEP-WT (TPS ≥ 1%)a TPS ≥50%-WT SP263 BEP-WT (TC SP263; TC ≥ 1%)a ≥50%-WT 100 Atezolizumab 100 Atezolizumab 100 Atezolizumab Chemotherapy Chemotherapy Chemotherapy 90 90 90 80 80 80 Overall Sur

  12. Slide 12: OS in PD-L1–Low Subgroups in IMpower110

    OS in PD-L1–Low Subgroups in IMpower110 SP142; SP142 TC3 or or (TC1/2 IC1/2-WT)a,b IC3-WT 22C3 22C3; BEP-WT (TPS 1-49%)a TPS ≥50%-WT SP263; TC SP263 BEP-WT (TC 1-49%)a ≥50%-WT 100 Atezolizumab 100 100 Atezolizumab Atezolizumab Chemotherapy Chemotherapy Chemotherapy 90 90 90 80 Overall Survival (%) 8

  13. Slide 13: PFS in PD-L1 Subgroups in IMpower110

    PFS in PD-L1 Subgroups in IMpower110 Median PFS, mo Subgroup n (%) PFS HR (95% CI)c Atezo Chemo SP142 BEP-WTa TC3 or IC3 205 (37) 0.59 (0.43, 0.82) 8.1 5.0 TC1/2/3 or IC1/2/3 554 (100) 0.77 (0.63, 0.93) 5.7 5.5 TC1/2 or IC1/2b 349 (63) 0.90 (0.71, 1.15) 5.5 5.6 22C3 BEP-WT 534 (100) 0.76 (0.62, 0.93

  14. Slide 14: Background: bTMB Assay

    Background: bTMB Assay • TMB is a promising biomarker for selecting patients who may benefit from PD-L1/PD-1 inhibitor therapy1-4 • In IMpower110, TMB was assessed using a blood-based assay1,a • A bTMB score of 16 is equivalent to 16 mutations/1.1 Mb, or ≈14.5 mutations/Mb • PD-L1 IHC (SP142 or 22C3

  15. Slide 15: Baseline Characteristics in the bTMB BEP-WT in IMpower110

    Baseline Characteristics in the bTMB BEP-WT in IMpower110 TC1/2/3 or IC1/2/3-WT bTMB BEP-WT Characteristic (n = 554) (n = 389) Median age (range) , y 64 (30-87) 65 (30-84) Male, n (%) 389 (70) 285 (73) ECOG PS 0, n (%) 199 (36) 138 (35) Current/previous tobacco use, n (%) 482 (87) 339 (87) Nsq histo

  16. Slide 16: OS in the bTMB BEP-WT in IMpower110

    OS in the bTMB BEP-WT in IMpower110 Median OS, mo Subgroup n (%) OS HR (95% CI)a Atezo Chemo TC1/2/3 or IC1/2/3-WT 554 (100) 0.83 (0.65, 1.07) 17.5 14.1 bTMB BEP-WT 389 (100) 0.98 (0.74, 1.30) 13.3 15.3 bTMB ≥ 10 175 (45) 0.87 (0.58, 1.30) 11.2 10.3 bTMB ≥ 16 87 (22) 0.75 (0.41, 1.35) 13.9 8.5 bTMB

  17. Slide 17: PFS in the bTMB BEP-WT in IMpower110

    PFS in the bTMB BEP-WT in IMpower110 Median PFS, mo Subgroup n (%) PFS HR (95% CI)a Atezo Chemo TC1/2/3 or IC1/2/3-WT 554 (100) 0.77 (0.63, 0.93) 5.7 5.5 bTMB BEP-WT 389 (100) 0.88 (0.70, 1.11) 5.5 5.4 . bTMB ≥ 10 175 (45) 0.74 (0.53, 1.05) 5.5 4.3 bTMB ≥ 16 87 (22) 0.55 (0.33, 0.92) 6.8 4.4 bTMB ≥

  18. Slide 18: Conclusions

    Conclusions • At the interim OS analysis, atezolizumab showed statistically significant and clinically meaningful OS improvement vs platinum-based chemotherapy in the PD-L1–high (by SP142) population (HR, 0.59 [95% CI: 0.40, 0.89]; P = 0.0106) • OS and PFS results were consistently in favour of atez

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