The next wave of successful drug therapy strategies in HER2-positive breast cancer. Hans Wildiers University Hospitals Leuven Belgium

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1 The next wave of successful drug therapy strategies in HER2-positive breast cancer Hans Wildiers University Hospitals Leuven Belgium

2 Trastuzumab in 1st Line significantly improved the prognosis of HER2-positive MBC Overall survival (%) OS HER2-negative HER2-positive with trastuzumab HER2-positive without trastuzumab Time (months from diagnosis) MBC, metastatic breast cancer Dawood et al. JCO 2010

3 OS Trastuzumab significantly improves overall survival in HER2-positive MBC Median overall survival (months) MBC, metastatic breast cancer *IHC3+ patients Slamon; Anti-Cancer Drugs 2001 Marty, JCO 2005 Valero et al. JCO 2010; 29(2): Slamon et al.* Marty et al. Taxanes Trastuzumab + taxanes Valero et al.

4 New anti-her2 drugs Lapatinib /Neratinib Baselga & Swain, Nature Reviews Cancer 2009

5 BO17929: A Phase II study of pertuzumab and trastuzumab in MBC that progressed during trastuzumab-based therapy Cohort 1 (n = 24) and Cohort 2 (n = 42) 1 HER2 positive MBC progressing on trastuzumab + CT PD Pertuzumab + trastuzumab Cohort 3 (n = 29, added after protocol amendment) 2 HER2 positive MBC progressing on trastuzumab + CT PD Pertuzumab PD 17 patients received Pertuzumab + trastuzumab Primary endpoints Objective response rate Clinical benefit rate (objective responses plus stable disease at 6 months) PD, progressive disease 1. Baselga J, et al. J Clin Oncol 2010; 28: ; 2. Cortés J, et al. J Clin Oncol 2012; 30:

6 Pertuzumab and Trastuzumab Phase II Proof of Concept study (BO17929) Patients (%) CR PR SD 0 HP CBR: 50% Cohort 1 +2 (HP) n=66 P CBR: 10.3% 7 3 Cohort 3 (P) n=29 P->HP CBR: 41.2% Cohort 3 (P -> HP) n= HP median PFS 5.5 months (Cohort 1+2) CR, complete response PR, partial response SD, stable disease CBR, clinical benefit rate P, pertuzumab H, trastuzumab 1. Baselga et al. J Clin Oncol 2010;28: ; 2. Baselga et al. SABCS Abstract 5114

7 Pertuzumab plus trastuzumab demonstrates a more comprehensive block of HER2 signalling compared to monotherapy alone in a mouse model KPL-4 breast cancer xenograft model Mean tumour volume (mm 3 ) ± SEM Vehicle control Pertuzumab (30 a /15 mg/kg/w ip) Trastuzumab (30 a /15 mg/kg/w ip) Pertuzumab (30 a /15 mg/kg/w ip) + trastuzumab (30 a /15 mg/kg/w ip) Treatment period (days) Single-agent pertuzumab and trastuzumab demonstrate similar efficacy; combination of the two leads to a more comprehensive blockade of HER2 signaling ip = intraperitoneal; SEM = standard error of the mean; a Loading dose Scheuer et al. Cancer Res 2009;69:

8 CLEOPATRA: Combination of pertuzumab with trastuzumab in HER2-positive first-line MBC Patients with HER2-positive first-line MBC central confirmation (N=808) 1:1 n=406 n=402 Placebo + trastuzumab Docetaxel 6 cycles recommended Pertuzumab + trastuzumab Docetaxel 6 cycles recommended PD PD Primary endpoint: Independently assessed PFS Secondary endpoints included Overall survival; PFS by investigator assessment; Safety Pertuzumab/Placebo: 840 mg loading dose, 420 mg q3w maintenance; Trastuzumab: 8 mg/kg loading dose, 6 mg/kg q3w maintenance; Docetaxel: 75 mg/m2 q3w, escalating to 100 mg/m2 if tolerated MBC, metastatic breast cancer; PD, progressive disease Baselga et al. NEJM 2012

9 CLEOPATRA : Independently assessed PFS showed significant benefit for pertuzumab arm PFS Progression-free survival (%) n at risk Ptz + T + D Pla + T + D Ptz + T + D: median 18.5 months Pla + T + D: median 12.4 months Time (months) Stratified 7 by prior 0 treatment 0 status and region D, docetaxel; PFS, progression-free survival; Pla, placebo; Ptz, pertuzumab; T, trastuzumab = 6.1 months HR = % CI p< Baselga et al. SABCS Oral presentation S5-5 Baselga et al. NEJM 2012;366(2):109-19

10 Combination of HER2-targeted therapy significantly improves efficacy in HER2-positive MBC TTP Time To Progression (months) 3.0 mths 7.1 mths 6.1 mths 11.7 mths 12.4 mths 18.5 mths months PFS MBC, metastatic breast cancer *IHC3+ patients Slamon; Anti-Cancer Drugs 2001 Marty, JCO 2005 Baselga, NEJM 2012 Slamon et al.* Marty et al. Baselga et al. taxanes Trastuzumab + taxanes Pertuzumab + trastuzumab + taxanes

11 Kaplan-Meier curves of the definitive confirmatory overall survival analysis showed significant benefit for pertuzumab arm OS Overall survival (%) n at risk Ptz + T + D Pla + T + D Time (months) % 89% 1 year years 81% 69% years % 50% Ptz + T + D: 113 events; median not reached Pla + T + D: 154 events; median 37.6 months HR= % CI p= Stopping boundary for concluding statistical significance at this second interim analysis was p D, docetaxel; Pla, placebo; Ptz, pertuzumab; T, trastuzumab Swain et al. SABCS 2012

12 Adverse events (all grades) with 25% incidence or 5% difference between arms n (%) Placebo + trastuzumab + docetaxel (n=396) Pertuzumab + trastuzumab + docetaxel (n=408) Diarrhea 191 (48.2) 278 (68.1) Alopecia 240 (60.6) 248 (60.8) Neutropenia 197 (49.7) 216 (52.9) Nausea 168 (42.4) 179 (43.9) Fatigue 148 (37.4) 155 (38.0) Rash 95 (24.0) 149 (36.5) Decreased appetite 105 (26.5) 121 (29.7) Mucosal inflammation 79 (19.9) 112 (27.5) Asthenia 121 (30.6) 110 (27.0) Vomiting 97 (24.5) 104 (25.5) Peripheral edema 122 (30.8) 101 (24.8) Pruritus 40 (10.1) 68 (16.7) Constipation 101 (25.5) 63 (15.4) Febrile neutropenia 30 (7.6) 56 (13.7) Dry skin 23 (5.8) 44 (10.8) Highlighted are adverse events with 5% higher incidence Swain et al. SABCS 2012

13 Grade 3 adverse events (incidence 5%) n (%) Placebo + trastuzumab + docetaxel (n=396) Pertuzumab + trastuzumab + docetaxel (n=408) Neutropenia 182 (46.0) 200 (49.0) Febrile neutropenia 30 (7.6) 56 (13.7) Leukopenia 59 (14.9) 50 (12.3) Diarrhea 20 (5.1) 37 (9.1) Grade 3 adverse events after docetaxel discontinuation Patients with adverse event, n (%) Placebo + trastuzumab (n=255) Pertuzumab + trastuzumab (n=298) Hypertension 3 (1.2) 5 (1.7) Diarrhea 0 (0.0) 3 (1.0) LVSD 5 (2.0) 2 (0.7) Fatigue 3 (1.2) 2 (0.7) Neutropenia 4 (1.6) 0 (0.0) Swain et al. SABCS 2012

14 There is no evidence that pertuzumab increases the incidence of cardiac adverse events n (%) Data cutoff date May 2011 (n=397) Placebo + trastuzumab + docetaxel May 2012 (n=396) Pertuzumab + trastuzumab + docetaxel May 2011 (n=407) May 2012 (n=408) LVSD (all grades) 33 (8.3) 34 (8.6) 18 (4.4) 22 (5.4) Symptomatic LVSD 7 (1.8) 7 (1.8) 4 (1.0) 5 (1.2) LVEF decline to <50% and by 10% points from baseline* 25/379 (6.6) 28/378 (7.4) 15/393 (3.8) 18/394 (4.6) LVEF recovery to 50%* 18/25 (72.0) 25/28 (89.3) 13/15 (86.7) 16/18 (88.9) * In patients with post-baseline assessment LVEF, left ventricular ejection fraction; LVSD, left ventricular systolic dysfunction Swain et al. SABCS 2012

15 Phase 2 EORTC Elderly trial (ML28116): 1st line trial pertuzumab + trastuzumab HER2 + MBC "elderly patients (n=80) R pertuzumab + trastuzumab + metronomic chemotherapy** PD T-DM1 (offered, but not mandatory) **cyclophosphamide 50 mg/d p.o. continuously Primary endpoint: - progression free survival at 6 months Secondary endpoints: - Overall survival - Breast cancer specific survival - Tumour Response rate as measured by RECIST Evolution of HRQoL assessed by EORTC QLQ-C30 and ELD 15 - Evolution of geriatric assessment - If T-DM1 after progression: PFS after starting T-DM1 NCT

16 NeoSphere: Study design and objectives Patients with operable or locally advanced /inflammatory* HER2-positive BC TH (n=107) docetaxel (75fi100 mg/m 2 ) trastuzumab (8fi6 mg/kg) THP (n=107) docetaxel (75fi100 mg/m 2 ) trastuzumab (8fi6 mg/kg) pertuzumab (840fi420 mg) S U R G Phase II design Primary endpoint: Comparison of pcr rates TH vs THP TH vs HP THP vs TP Chemo-naïve & primary tumors >2cm (N=417) HP (n=107) trastuzumab (8fi6 mg/kg) pertuzumab (840fi420 mg) TP (n=96) docetaxel (75fi100 mg/m 2 ) pertuzumab (840fi420 mg) E R Y Secondary endpoints: Clinical response DFS Breast conservation rate Biomarker evaluation Study dosing: q3w x 4 Gianni L, et al. Lancet Oncol 2011 DOI: /S (11)

17 NeoSphere: Primary endpoint pcr (pathologic complete response in ITT population) pcr 50 p= p= p= pcr, % 95% CI H, trastuzumab; P, pertuzumab; T, docetaxel p values from Cochran-Mantel-Haenszel test and adjusted for multiplicity TH THP HP TP Gianni L, et al. Lancet Oncol 2011 DOI: /S (11)

18 TRYPHAENA: A Phase II study of pertuzumab and trastuzumab in the neoadjuvant setting All three arms are experimental Pertuzumab + trastuzumab (Cycles 1 6) + FEC (Cycles 1 3) + docetaxel (Cycles 4 6) S U HER2-positive EBC (N = 225) FEC (Cycles 1 3) fi pertuzumab + trastuzumab + docetaxel (Cycles 4 6) R G E Trastuzumab to complete 1 year R Pertuzumab + trastuzumab + docetaxel + carboplatin (Cycles 1 6) Y pcr 45-52% in 3 arms Very few cardiac events: - Symptomatic LVSD (grade 3) 0-3% - LVEF decline 10% points and below 50% 4-5% FEC, 5-fluorouracil, epirubicin, cyclophosphamide Schneeweiss A, et al. SABCS 2011 (Abstract S5 6; oral presentation);

19 Phase 3 APHINITY trial (BO25126): Adjuvant trial S U R G E R Y Central confirmation of HER2 status R A N D O M I Z A T I O N Chemotherapy plus trastuzumab and pertuzumab Chemotherapy plus trastuzumab and placebo F O L L O W U P 10 Y E A R S NCT Randomisation within 7 weeks of surgery Start treatment within 1 week Anti HER2 therapy for a total of 1 year (52 weeks) Radiotherapy and/or endocrine therapy may be started at the end of adjuvant chemotherapy

20 T-DM1 in MBC: Phase III study EMILIA: T-DM1 compared with lapatinib+capecitabine HER2+ (central) LABC or MBC (N=980) Prior taxane and trastuzumab Progression on metastatic treatment or within 6 months of adjuvant therapy 1:1 T-DM1 PD Lapatinib + Capecitabine PD Stratification factors: World region, number of prior chemo regimens for MBC or unresectable LABC, presence of visceral disease Primary end points: PFS by independent review, OS, and safety Key secondary end points: PFS by investigator, ORR, DOR, time to symptom progression Blackwell et al. J Clin Oncol 2012

21 EMILIA: Progression-Free Survival by Independent Review PFS Proportion progression-free Median (months) No. of events Cap + Lap T-DM Stratified HR=0.650 (95% CI, 0.55, 0.77) P< Time (months) No. at risk by independent review: Cap + Lap T-DM Unstratified HR=0.66 (P<0.0001).

22 EMILIA: Significant Overall Survival benefit OS % Median (months) No. of events Cap + Lap T-DM Stratified HR=0.682 (95% CI, 0.55, 0.85); P= Efficacy stopping boundary P= or HR=0.727 Proportion surviving % 51.8% 64.7% Time (months) No. at risk: Cap + Lap T-DM Data cut-off July 31, 2012; Unstratified HR=0.70 (P=0.0012). ESMO, 2012

23 EMILIA: safety data Safety endpoints favoured T-DM1 T-DM1 (n = 490) Lapatinib/capecitabine (n = 488) Adverse event All Grades, % Grade 3 4, % All Grades, % Grade 3 4, % Diarrhea Hand-foot syndrome Vomiting Neutropenia Hypokalemia Fatigue Nausea Mucosal inflammation Thrombocytopenia Increased AST Increased ALT Anemia Blackwell et al. J Clin Oncol 2012 ALT = alanine aminotransferase; AST= aspartate aminotransferase

24 Phase 2 ZEPHIR trial (MO27955) Prospective Imaging study HER2+ MBC (n=60) T-DM1 3.6 mg/kg x 1 T-DM1 3.6 mg/kg Q3w x 2 T-DM1 3.6 mg/kg Q3w until progression or severe toxicity FDG-PET/CT + 89 Zr-trastuzumab PET/CT + Biopsy + Brain MRI Early FDG-PET/CT Late FDG-PET/CT RECIST MRI Primary endpoint: - To show that pre-treatment 89 Zr-trastuzumab PET/CT is able to select lesions not responding from treatment with T-DM1 Secondary endpoint: - To show that early FDG PET/CT is able to select lesions not responding from treatment with T-DM1 Patient Eligibility: - HER2-positive locally recurrent or metastatic disease scheduled for a first or any subsequent metastatic treatment line - The patient must have at least 2 visceral or nodal target metastatic lesions - A biopsy of a metastatic site is required if not done previously - Primary tumour blocks available for confirmatory central laboratory HER2 testing NCT

25 Combining T-DM1 with pertuzumab results in enhanced anti-tumour activity KPL-4 breast cancer xenograft model Mean tumour volume (mm 3 ) ± SEM Pertuzumab T-DM Time (days) Vehicle control Pertuzumab (15 mg/kg ip) T-DM1 (1 mg/kg iv) T-DM1 (1 mg/kg iv) + pertuzumab (15 mg/kg ip) ip, intraperitoneal; iv, intravenous; SEM, standard error of the mean Adapted from Fields C, et al. AACR 2010 (Abstract 5607; poster presentation).

26 MARIANNE: T-DM1 + Pertuzumab in first line HER2+ MBC Primary endpoints: MARIANNE: T-DM1 in combination with pertuzumab in the treatment of first-line HER2-positive MBC PFS, safety HER2-positive MBC No prior chemotherapy (n = 1092) Trastuzumab + taxane T-DM1 + pertuzumab T-DM1 + placebo Secondary endpoints: ORR, OS, CBR, TTF, DoR NCT TTF = time to treatment failure; DoR = duration of response

27 Timelines SABCS 2011 CLEOPATRA results June 8 th 2012 FDA approval for Pertuzumab in 1L HER2+ MBC March 4 th 2013 EU label for Pertuzumab in 1L HER2+ MBC ASCO/ESMO 2012 EMILIA results Feb 22 th 2013 FDA approval T-DM1 in 2L+ HER2+ MBC * Q EU label T-DM1 in 2L+ HER2+ MBC * Estimated timeline

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