Roche Holding Ltd · SIX:RO

Roche — Technical Presentation (2019)

13 slides from Roche's technical presentation, 2019

  1. Slide 1: Performance of PD-L1 immunohistochemistry assays in unresectable locally advanced or metastatic TNBC

    Performance of PD-L1 immunohistochemistry assays in unresectable locally advanced or metastatic triple-negative breast cancer: post hoc analysis of IMpassion130 Hope S. Rugo,1 Sherene Loi,2 Sylvia Adams,3 Peter Schmid,4 Andreas Schneeweiss,5 Carlos H. Barrios,6 Hiroji Iwata,7 Véronique Diéras,8 Eric

  2. Slide 2: Disclosures

    Disclosures 2  Research support for the parent study and editorial support from F. Hoffman-La Roche, Ltd.  Research support to the University of California, San Francisco from Immunomedics, Daiichi Sankyo, Eisai, Eli Lilly, Genentech, Inc./F. Hoffmann-La Roche, Ltd, MacroGenics, Merck, Novartis, O

  3. Slide 3: Background

    Background 3  IMpassion130 is the first Phase III study of cancer immunotherapy in mTNBC to demonstrate clinical benefit in PD-L1+ patients1,2 − Atezolizumab + nab-paclitaxel is approved in the United States3 and European Union4 and recommended for the treatment of patients with PD-L1 IC+ mTNBC in

  4. Slide 4: PD-L1 IC status by SP142 predicts PFS and OS benefit with atezolizumab + nab-paclitaxel

    PD-L1 IC status by SP142 predicts PFS and OS 4 benefit with atezolizumab + nab-paclitaxel1,2 Median PFS HR Median OS HR Population Population A + nP P + nP (95% CI) A + nP P + nP (95% CI) 100 0.63 100 0.71 Progression-Free Survival (%) PD-L1 IC+ (41%) 7.5 mo 5.3 mo PD-L1 IC+ 25.0 mo 18.0 mo (0.50, 0

  5. Slide 5: PD-L1 status in primary vs metastatic tissues

    PD-L1 status in primary vs metastatic tissues 5 Efficacy in PD-L1 IC+ PD-L1 status by primary vs metastatic tissuea PFS OS Primary tissue HR, 0.61 (95% CI: 0.47, 0.81) HR, 0.79 (95% CI: 0.57, 1.09) (62%) 44% P = 0.014 Primary Metastatic tissue Survival (%) Survival (%) (38%) 36% 0% 20% 40% 60% PD-L1

  6. Slide 6: Methods

    Methods 6  Central testing of VENTANA PD-L1 SP142, DAKO 22C3 and VENTANA PD-L1 SP263 IHC assays were performed according to the respective package insertsa − Each slide was read by a single pathologist out of a panel of 8 pathologistsb − Pathologists were trained and qualified to read IC 1% (SP142

  7. Slide 7: PD-L1 IHC assays: prevalence and analytical concordance

    PD-L1 IHC assays: prevalence and 7 analytical concordance PD-L1+ SP142 (IC 1%) SP142 (IC 1%) prevalence and 22C3 (CPS 1) and SP263 (IC 1%) 100% SP142+ SP142+ 81% 22C3- SP263- 80% 75% (1%) (1%) SP142+ SP142+ PD-L1+ Cases 60% 22C3+ SP263+ b (45%)a (45%)a 46% 40% SP142- SP142- 22C3+ SP263+ 20% (36%) SP

  8. Slide 8: sTILs in PD-L1 subgroups defined by SP142 and 22C3 or SP263

    sTILs in PD-L1 subgroups defined by 8 SP142 and 22C3 or SP263 SP142 (IC 1%) and 22C3 (CPS 1) SP142 (IC 1%) and SP263 (IC 1%) PD-L1 Median sTILs PD-L1 Median sTILs Status n (IQR) Status n (IQR) SP142+ 10% SP142+ 10% 274 274 22C3+ (5-20) SP263+ (5-20) **** **** SP142- 5% SP142- 5% 214 177 **** **** 22

  9. Slide 9: Clinical outcomes in PD-L1+ populations per SP142, 22C3 and SP263

    Clinical outcomes in PD-L1+ populations 9 per SP142 (IC 1%), 22C3 (CPS 1) and SP263 (IC 1%) Population PFS OS Median PFS, mo HR Median OS, mo HR A + nP P + nP ∆ (95% CI) A + nP P + nP ∆ (95% CI) SP142 8.3 4.1 4.2 0.60 (0.47, 0.78) 27.3 17.9 9.4 0.74 (0.54, 1.01) IC ≥ 1%: 46% Atezolizumab + nab-pacli

  10. Slide 10: Clinical outcomes in BEP subpopulations defined by SP142 and 22C3

    Clinical outcomes in BEP subpopulations 10 defined by SP142 (IC 1%) and 22C3 (CPS 1) Population PFS OS Median PFS, mo HR Median OS, mo HR A + nP P + nP ∆ (95% CI) A + nP P + nP ∆ (95% CI) 8.3 3.9 4.4 0.60 (0.46, 0.78) 27.3 18.0 9.3 0.71 (0.52, 0.98) SP142+ 22C3+ Survival (%) Survival (%) (45%; 279/6

  11. Slide 11: Clinical outcomes in BEP subpopulations defined by SP142 and SP263

    Clinical outcomes in BEP subpopulations 11 defined by SP142 (IC 1%) and SP263 (IC 1%) Population PFS OS Median PFS, mo HR Median OS, mo HR A + nP P + nP ∆ (95% CI) A + nP P + nP ∆ (95% CI) 8.3 4.1 4.2 0.61 (0.47, 0.79) 27.3 17.9 9.4 0.71 (0.52, 0.97) SP142+ SP263+ Survival (%) Survival (%) (45%; 278

  12. Slide 12: Conclusions

    Conclusions 12 In this post hoc exploratory biomarker sub-study of the IMpassion130 trial  Clinical activity was observed in the SP142 PD-L1 IC+ subgroup, regardless of whether the sample was from the primary tumour or metastatic tissue  With overall percentage agreements of 64% (22C3) and 69% (SP

  13. Slide 13: Acknowledgements

    Acknowledgements 13  The patients and their families  The investigators and clinical study sites  Celgene for providing nab-paclitaxel for this study  This study is sponsored by F. Hoffmann-La Roche, Ltd.  Medical writing assistance for this oral presentation was provided by Steffen Biechele, P

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