A vision for HER2 future

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1 School of Medical Oncology Department of Medical and Biological Sciences - University of Udine Department of Oncology - University Hospital of Udine A vision for HER2 future Current therapeutic algorithm and future perspectives HER2 e tumore mammario Lorenzo Gerratana

2 The Agenda What s up? Where we were The trastuzumab revolution Slamon DJ, et al. N Engl J Med. 2001;344(11): Bonotto, M, et al. The Oncologist, 19(6), Where we are currently Landmark studies and the therapeutic cascade José Baselga, Mario Campone, Martine Piccart, N Engl J Med 2012;366:520-9 Swain SM et al. ESMO 2014 Krop IE, et al. Lancet Oncol 2014 Jun;15(7): Ellis PA, et al ASCO Annual Meeting What's in the future Future perspectives of AntiHER2 treatments Arpino G, et al. ESMO 2012 André F, et al. Lancet Oncol. 2014;15(6): Hurvitz SA, et al. Lancet Oncol 2015 Jul;16(7): Jordan NV, et al. Nature 2016 Aug 24;537(7618):102 6

3 Targeting the HER2 pathway Trastuzumab Angiogenesis Survival Cell cycle control Apoptosis Proliferation

4 Targeting the HER2 pathway The trastuzumab revolution Slamon DJ, et al. N Engl J Med. 2001;344(11):

5 Targeting the HER2 pathway Checking the real world Bonotto, M, et al. The Oncologist, 19(6),

6 The timeline Major Clinical Advances Over The Past 15 Years Initial Randomized Trial Demonstrating Benefit of Trastuzumab 2002 Three Large Adjuvant Trials Reported Lapatinib Approved Phase II Randomized Trial of T-DM Phase III of Pertuzumab 2012 Pertuzumab Preop Approval 1998 First Preoperative Trials Reported Initial Trials Of T-DM1, Pertuzumab, Neratinib 2010 Preoperative Trials of Dual Blockade 2011 Phase III of T-DM1 vs Cape/Lap 2013

7 The AntiHER2 therapy 2.0 Trastuzumab Ado-trastuzumab emtansine Pertuzumab Lapatinib Neratinib Angiogenesis Survival Cell cycle control Apoptosis Proliferation

8 The landmark trials

9 The CLEOPATRA Trial Pertuzumab, the first-in-class HER3-HER2 dimerization inhibitor Patients with HER2-positive MBC centrally confirm ed (N = 808) n=406 1:1 n=402 Placebo + trastuzum ab Docetaxel 6 cycles recommended Pertuzum ab + trastuzum ab Docetaxel 6 cycles recommended CLEOPATRA Double-blind, placebo-controlled, phase 3 trial, 1:1 randomization, stratification according to geographical region and previous treatment status. Patients with HER2-positive first-line metastatic breast cancer The primary endpoint was progression-free survival (assessed independently) José Baselga, Mario Campone, Martine Piccart, N Engl J Med 2012;366:520-9

10 The CLEOPATRA Trial Final overall survival results OS (%) n at risk Ptz + T + D Pla + T + D HR % CI = 0.56, 0.84 p = Time (months) months Δ 15.7 months Ptz + T + D Pla + T + D 56.5 months Swain SM et al. ESMO 2014

11 The TH3RESA Trial T-DM1, the first-in-class HER2-targeted antibody-drug conjugate HER2-positive (central) advanced BC a (N=600) 2 T-DM1 3.6 mg/ kg q3w I V (n=400) PD 2 prior HER2-directed therapies for advanced BC Prior treatment with trastuzumab, lapatinib, and a taxane 1 Treatment of physician s choice (TPC) b (n=200) PD T-DM1 c (optional crossover) TH3RESA Randomized 2:1, open-label, phase III trial, progressive HER2-positive advanced breast cancer after two or more HER2-directed regimens in the advanced setting. Patients were stratified according to world region, number of previous regimens and visceral disease. Coprimary endpoints: PFS and overall survival. Krop IE, et al. Lancet Oncol 2014 Jun;15(7):689 99

12 The TH3RESA Trial Interim overall survival results Krop IE, et al. Lancet Oncol 2014 Jun;15(7):689 99

13 The TH3RESA Trial Biomarker exploratory analysis Kim SB, et al. Int J Cancer Jul 26;139(10):

14 The MARIANNE Trial Adding T-DM1 to Pertuzumab Trastuzumab + docetaxel or paclitaxel Locally recurrent or mbc HER2 positivity Candidate for chemotherapy Measurable or nonmeasurable disease R T-DM1 + pertuzumab T-DM1 + placebo MARIANNE Randomized 1:1:1, phase III study, pertuzumab-placebo The primary endpoint was PFS. HER2-positive progressive/recurrent locally advanced BC or previously untreated MBC with a 6-month interval since treatment in the (neo)adjuvant setting with taxanes or vinca alkaloids Ellis PA, et al ASCO Annual Meeting

15 The MARIANNE Trial Non inferior, but not superior None of the TDM1-containing regimen arms significantly improved PFS compared to trastuzumab plus chemotherapy. Side effects in the two experimental arms of the study were consistent with those seen in previous studies of T-DM1 and/or pertuzumab. Ellis PA, et al ASCO Annual Meeting

16 So, what are we supposed to do?

17 The treatment algorithm The abundance paradox First-line Second-line Third-line Pertuzumab + trastuzumab + docetaxel Pertuzumab + trastuzumab + paclitaxel Anti-HER2 therapy (trastuzumab or lapatinib) + chemotherapy Trastuzumab + lapatinib AI + trastuzumab or lapatinib Trastuzumab T-DM1 Lapatinib + capecitabine Trastuzumab + capecitabine Trastuzumab ± chemotherapy Trastuzumab + lapatinib Pertuzumab + trastuzumab + taxane/second-line chemotherapy / ± cytotoxic agents AI + anti-her2 therapy Trastuzumab Trastuzumab and/or lapatinib combinations

18 The treatment algorithm The therapeutic cascade Trastuzumab-Sensitive (No adj Trast or TFI>6 months) Trastuzumab-Resistant/refractory (Adj Trast and TFI<=6 months) First-line Trastuzumab+Pertuzumab+Taxane TDM1 Second-line TDM1 Lapatinib+Capecitabine Third-line Lapatinib+Capecitabine Trastuzumab+Chemotherapy Fourth-line Trastuzumab+Chemotherapy Trastuzumab+Chemotherapy Very indolent disease Chemo-unwilling/unfit pts Aromatase Inhibitors + Trastuzumab or Lapatinib Advanced lines, Chemo-unwilling/unfit pts, HER2+ HR- Trastuzumab + Lapatinib

19 What's in the future

20 Targeted and endocrine therapy

21 TANDEM Looking for a new partner AntiHER2 and endocrine therapy Phase III trial, anastrozole with or without trastuzumab, included 207 patients Median PFS of 4.8 months for trastuzumab plus anastrozole vs 2.4 months for the control (p = ) No difference in OS, but 70% of patients crossed over PATRICIA Ongoing, trastuzumab and palbociclib with or without letrozole Lapatinib and letrozole Phase III trial, letrozole with or without lapatinib, included 219 patients Median PFS 8.2 months for of the lapatinib plus letrozole vs 3.0 months for the control arm (p=0.019) Grade 3 or 4 AEs: diarrhea and rash

22 The PERTAIN Trial Endocrine therapy and induction chemotherapy PERTAIN open-label, randomised Phase II study Patients are randomised 1:1, prior to randomisation, investigators will choose whether patients also receive induction chemotherapy (docetaxel or paclitaxel). Primary endpoint is PFS Arpino G, et al. ESMO 2012

23 mtor/pi3k inhibitors

24 Progression Randomization 1:1 mtor and anti-her2 therapy resistance The BOLERO-3 Trial Everolimus (5 mg/day) / Trastuzumab q7 / Vinorelbine q7 (N=284) N=569 Stratification: Previous lapatinib use Placebo / Trastuzumab q7 / Vinorelbine q7 (N=285) BOLERO-3 Double-blind, placebo-controlled, phase 3 trial, 1:1 randomization and stratification by previous lapatinib use HER2-positive disease, trastuzumab-resistant, previously treated with taxane therapy. Primary endpoint was progression-free survival André F, et al. Lancet Oncol. 2014;15(6):580 91

25 mtor and anti-her2 therapy resistance The BOLERO-3 Trial André F, et al. Lancet Oncol. 2014;15(6):580 91

26 Looking at the first line The BOLERO-1 Trial Hurvitz SA, et al. Lancet Oncol 2015 Jul;16(7):816 29

27 Looking at the first line The BOLERO-1 Trial Hurvitz SA, et al. Lancet Oncol 2015 Jul;16(7):816 29

28 mtor and anti-her2 therapy resistance Ongoing trials NCT Phase I, open-label, single arm T-DM1 in combination with an oral PI3K inhibitor BYL719. HER2-positive locally advanced or MBC whose disease has progressed on trastuzumab and taxane-based regimens. Primary objectives are to determine safety, tolerability, feasibility, and MTD. NCT Phase I/II, open-label T or T+P in combination with an oral pan-pi3k inhibitor XL147. Advanced or recurrent HER2+ MBC disease refractory to T Primary objectives are to determine safety, tolerability, MTD and objective tumor response.

29 Blockade of PD-1/PD-L1

30 Immunotherapy Changes in PD-1 expression after antiher2 therapy Low Medium High Varadan V, et al. Clin Cancer Res / CCR

31 Immunotherapy Ongoing trials NCT Phase Ib, Open-Label, Two-Arm Study HER2 positive metastatic and locally advanced early breast cancer The Safety And Pharmacokinetics of Atezolizumab in combination with T- DM1 or Trastuzumab And Pertuzumab NCT Phase II, double-blind, randomized, placebo-controlled study HER2-positive locally advanced or metastatic breast cancer after trastuzumab +/- taxane and/or who have progressed within 6 months after completing adjuvant therapy. Primary endpoint: Progression Free Survival (PFS)

32 Power is nothing without control

33 Looking for a dynamic biomarker Circulating tumor cells and great promises Jordan NV, et al. Nature 2016 Aug 24;537(7618):102 6

34 The End Thank ou

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