Roche Holding Ltd · SIX:RO

Roche — San Antonio Breast Cancer Symposium 2023

20 slides from Roche's conference presentation, December 2023

  1. Slide 1: KATHERINE final IDFS and updated OS analysis

    Phase III study of adjuvant ado-trastuzumab emtansine vs trastuzumab for residual invasive HER2-positive early breast cancer after neoadjuvant chemotherapy and HER2-targeted therapy: KATHERINE final IDFS and updated OS analysis Sibylle Loibl, Max S. Mano, Michael Untch, Chiun-Sheng Huang, Eleftherio

  2. Slide 2: Disclosure information

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Disclosure information Sibylle Loibl I have the following relevant financial relationships to disclose: Grants and other support from Roche during the conduct of the study; grants and other support from AstraZeneca, AbbVie, Amgen, DSI, Gilead

  3. Slide 3: KATHERINE study design

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 KATHERINE study design ▪ Prior neoadjuvant therapy consisting of: T-DM1 – Minimum 6 cycles of chemotherapy 3.6 mg/kg IV Q3W R 14 cycles – Minimum 9 weeks of trastuzumab 1:1 – Second HER2-targeted agent allowed ▪ Residual invasive tumor in bre

  4. Slide 4: KATHERINE primary analysis (2018): T-DM1 reduced risk of recurrence versus trastuzumab

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 KATHERINE primary analysis (2018): T-DM1 resulted in a 50% reduction in risk of recurrence of invasive disease or death versus trastuzumab IDFS OS 100 3-year 100 88.3% 80 80 T-DM1 T-DM1 Trastuzumab 77.0% Trastuzumab IDFS rate (%) OS rate (%)

  5. Slide 5: Analysis milestones

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Analysis milestones IDFS PA / IDFS FA / OS FA 1st OS IA 2nd OS IA CCOD: CCOD: Calendar-driven: July 25, 2018 October 5, 2023 12 years after FPI ▪ FA of IDFS: Event-driven, after approximately 384 events have been recorded – There were 385 pat

  6. Slide 6: Patient disposition

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Patient disposition Trastuzumab T-DM1 Randomized, ITT, n 743 743 Treated, n 720 740 Alive and on study, n (% of ITT) 461 (62.0) 521 (70.1) Discontinued from study, n (%) With IDFS event reported 159 (21.4) 105 (14.1) Prior to IDFS event* 123

  7. Slide 7: Baseline characteristics of the ITT population: Stratification factors

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Baseline characteristics of the ITT population: Stratification factors Trastuzumab (n = 743) T-DM1 (n = 743) Clinical stage at presentation, n (%) Stages cT1–3N0–1M0 (operable) 553 (74.4) 558 (75.1) Stage cT4NxM0 or cTxN2–3M0 (inoperable) 190

  8. Slide 8: KATHERINE IDFS final analysis; median follow-up 8.4 years

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 KATHERINE IDFS final analysis; median follow-up 8.4 years (101 months) 100 3 years 5 years 88.4% 7 years 84.4% 80.8% 80 77.1% 72.2% 67.1% IDFS rate (%) 60 40 Trastuzumab T-DM1 T-DM1 (n = 743) (n = 743) Trastuzumab 20 IDFS events, no. (%) 239

  9. Slide 9: Final IDFS analysis: Subgroups (1/2)

    Final IDFS analysis: Subgroups (1/2) Trastuzumab (n = 743) T-DM1 (n = 743) Total Patients per 7-year Patients per 7-year Hazard T-DM1 Trastuzumab Baseline risk factors n group n events IDFS group n events IDFS ratio 95% CI better better All 1486 743 239 67.1 743 146 80.8 0.54 (0.44, 0.66) Clinical s

  10. Slide 10: Final IDFS analysis: Subgroups (2/2)

    Final IDFS analysis: Subgroups (2/2) Trastuzumab (n = 743) T-DM1 (n = 743) Total Patients per 7-year Patients per 7-year Hazard T-DM1 Trastuzumab Baseline risk factors n group n events IDFS group n events IDFS ratio 95% CI better better All 1486 743 239 67.1 743 146 80.8 0.54 (0.44, 0.66) Primary tu

  11. Slide 11: Site of first occurrence of an IDFS event

    Site of first occurrence of an IDFS event 35 32.2 30 Number of patients (%) 25 21.5 19.7 20 14.7 15 T-DM1 Trastuzumab 10 6.2 5 CNS* 2.6 CNS* 2.2 1.9 1.9 (7.0) 0.9 (5.1) 0 Total patients with Distant Locoregional Contralateral Death without IDFS event recurrence recurrence breast cancer prior event *

  12. Slide 12: Follow-up medications after IDFS events (ITT)

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Follow-up medications after IDFS events (ITT) Trastuzumab (n = 743) T-DM1 (n = 743) Total number of patients with an IDFS event, n 239 146 Total number of patients with documentation of 169 (70.7) 94 (64.4) ≥1 treatment following an IDFS even

  13. Slide 13: KATHERINE 2nd OS interim analysis; median follow-up 8.4 years

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 KATHERINE 2nd OS interim analysis; median follow-up 8.4 years (101 months) 3 years 5 years 7 years 100 95.1% 91.4% 89.1% 93.6% 87.7% 80 84.4% OS rate (%) 60 Trastuzumab T-DM1 (n = 743) (n = 743) 40 Events, no. (%) 126 (17.0) 89 (12.0) T-DM1 2

  14. Slide 14: Summary of deaths

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Summary of deaths Trastuzumab (n = 720) T-DM1 (n = 740) Total number of deaths, n (%) 126 (17.5) 89 (12.0) Cause of death Breast cancer 108 (15.0) 70 (9.5) Adverse event 0 1 (0.1)* Other† 18 (2.5) 18 (2.4) * Fatal adverse event was intracrani

  15. Slide 15: 2nd OS interim analysis: Subgroups (1/2)

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 2nd OS interim analysis: Subgroups (1/2) Trastuzumab (n = 743) T-DM1 (n = 743) Total Patients per 7-year Patients per 7-year Hazard T-DM1 Trastuzumab Baseline risk factors n group n events OS group n events OS ratio 95% CI better better All 1

  16. Slide 16: 2nd OS interim analysis: Subgroups (2/2)

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 2nd OS interim analysis: Subgroups (2/2) Trastuzumab (n = 743) T-DM1 (n = 743) Total Patients per 7-year Patients per 7-year Hazard T-DM1 Trastuzumab Baseline risk factors n group n events OS group n events OS ratio 95% CI better better All 1

  17. Slide 17: Related AEs during the post-treatment period

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Related AEs during the post-treatment period* Patients, n (%) with ≥1: Trastuzumab (n = 720) T-DM1 (n = 740) AE (any grade, >1 patient in either arm) 12 (1.7) 24 (3.2) Investigations 5 (0.7) 9 (1.2) Cardiac disorders 5 (0.7) 5 (0.7) Nervous s

  18. Slide 18: KATHERINE summary and conclusions

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 KATHERINE summary and conclusions ▪ After 8.4 years (101 months) median follow-up, T-DM1 significantly improved OS in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy • Hazard ratio 0.66

  19. Slide 19: Thank you

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 Thank you To all the patients who participated in KATHERINE along with their families, with special acknowledgment to those on the control arm To the KATHERINE investigators and their research staff at the 273 sites in 28 countries Research s

  20. Slide 20: KATHERINE investigators

    San Antonio Breast Cancer Symposium ®, December 5–9, 2023 KATHERINE investigators Argentina – L Fein, L Kaen, G Lerzo Austria – D Egle, R Greil, M Hubalek, C Singer, G Steger Belgium – L Dirix, F Duhoux, G Jerusalem, V Renard Brazil – R Araujo, A Boukai, R Hegg, JP Lima, M Mano, A Morelle, AP Muller

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