What is the optimal sequence of anti-her2 therapy in metastatic breast cancer?

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1 What is the optimal sequence of anti-her2 therapy in metastatic breast cancer? David Miles Mount Vernon Cancer Centre Northwood Middlesex UKBCM mee)ng: London 2013

2 Herceptin plus a taxoid extends survival compared with taxoid alone Paclitaxel Docetaxel H+P IHC 3+ (n=68) P IHC 3+ (n=77) H+D (n=92) (n=94) ORR (%) * 36 D DR (median, months) TTP (median, months) OS (median, months) ** *** H = Herceptin ; P = paclitaxel; D = docetaxel * p=0.001; ** p=<0.05; ***p= Slamon D, et al. N Eng J Med 2001;344: Marty et al JCO, 2005; 23:

3 With trastuzumab, HER2-positive disease no longer dictates the probability of survival in MBC Overall survival (%) HER2-normal HER2-positive with trastuzumab HER2-positive without trastuzumab Time (months from diagnosis) MBC, metastatic breast cancer Dawood et al. JCO 2010

4 Importance of continued HER2 inhibition What to do beyond disease progression? Herceptin beyond progression (GBG-26) n=156 Cap + trast Cap P value Lapatinib with capecitabine ( 151 study) n=399 Cap + Lap Cap P value TTP (months) TTP (months) <0.001 RR (%) CBR (%) RR (%) OR= CBR (%) OR= OS (months) OS (months) von Minckwitz JCO (2009) 27: Cameron BCRT (2008) 112:

5 Importance of combined HER2 inhibition Herceptin and Lapatinib Downstream signaling cascade

6 Importance of combined HER2 inhibition EGF : lapatinib ± trastzumab Key Inclusion HER2+(FISH+/ IHC3+) MBC Progression on Anthracycline Taxane Trastuzumab Progression on most recent trastuzumab regimen Stratification Factors Visceral Disease Hormone Receptor R A N D O M I Z A T I O N Lapatinib 1500 mg/day PO N=148 Crossover if PD after 4wk therapy (N=73) Lapatinib 1000 mg/day PO Trastuzumab 4 2 mg/kg IV qw N=148 Blackwell, JCO 2012, 30:

7 Cumulative % Alive without Progression EGF : Lapatinib ± trastuzumab progression-free survival Subjects At Risk L 148 L+T % % L N = 145 L+T N = 146 Progressed or Died, n Median, wks Hazard ratio (95% CI) 0.73 (0.57, 0.93) P value Mo PFS Time from Randomization (wks) Blackwell, JCO 2012, 30:

8 EGF : Lapatinib ± trastuzumab overall survival Died n (%) Median P-value Lapatinib (n=145) 113 (78%) 9.5 months Lapatinib + trastuzumab (n=146) 105 (72%) 14 months HR: 0.74 (95% CI 0.57, 0.97) Survival (%) Time from randomisation (months) EMA licensing recommendation ER+ve ER-ve Lapatinib 11 months 9 months Lapatinib + trastuzumab 12 months 16 months Blackwell, JCO 2012, 30:

9 Importance of combined HER2 inhibition Herceptin and Lapatinib Pertuzumab Downstream signaling cascade Activates antibody-dependent cellular cytotoxicity Prevents receptor dimerisation Potent inhibitor of HER2/HER2- and HER2/HER3-mediated signalling pathways

10 Pertuzumab-Herceptin is effective in patients whose disease is progressing on herceptin (P + H) (n=66) CR, % 7.6 PR, % 16.7 ORR, % 24.2 SD >6 months, % 25.8 CBR, % (CR + PR + SD >6 months) 50.0 PD, % 50.0 CBR, clinical benefit rate; CR, complete response; ORR, overall response rate; P, Perjeta; PD, progressive disease; PR, partial response; SD, stable disease; H, Herceptin; cohorts 1 and 2 were a Simon 2-stage design 1. Baselga J et al. J Clin Oncol 2010;

11 The importance of combined HER2 inhibition CLEOPATRA n=406 Placebo + trastuzumab PD Patients with HER2-positive MBC centrally confirmed (N=808) 1:1 Docetaxel 6 cycles recommended Pertuzumab + trastuzumab PD n=402 Docetaxel 6 cycles recommended Randomization was stratified by geographic region and prior treatment status (neo/adjuvant chemotherapy received or not) HER2, human epidermal growth factor receptor 2; MBC, metastatic breast cancer; PD, progressive disease 11

12 Cleopatra: Docetaxel & herceptin ± pertuzumab. Independently reviewed objective response Placebo + Herceptin + docetaxel (n=336) Perjeta + Herceptin + docetaxel (n=343) Objective response rate, n (%) 233 (69.3) 275 (80.2) Difference in response rates (95% CI) 10.8 % points ( ) P=0.001* Complete response rate, n (%) Partial response rate, n (%) 14 (4.2) 219 (65.2) 19 (5.5) 256 (74.6) Stable disease, n (%) 70 (20.8) 50 (14.6) Progressive disease, n (%) 28 (8.3) 13 (3.8) Unable to assess or no assessment, n (%) 5 (1.5) 5 (1.5) J Baselga et al N Engl J Med 2012;366:109-19

13 Cleopatra: Docetaxel & herceptin ± pertuzumab. Updated investigator assessed PFS Progression-free survival (%) n at risk Pjt + H + D Time (months) Pla + H + D Analysis was exploratory only D, docetaxel; PFS, progression-free survival; Pla, placebo; Pjt, Perjeta; H, Herceptin 218 Pjt + H + D: median 18.7 months Pla + H + D: median 12.4 months Pjt + H + D Pla + H + D Independently assessed PFS, data cut-off: May HR= % CI =6.3 months Swain et al. San Antonio Breast Cancer Symposium 2012, Poster P

14 Cleopatra: Docetaxel & herceptin ± pertuzumab. Updated overall survival Overall survival (%) year 94% 89% 2 years 81% 69% Time (months) 3 years 66% 50% Ptz + T + D: 113 events; median not reached Pla + T + D: 154 events; median 37.6 months HR= % CI p= Swain et al. San Antonio Breast Cancer Symposium 2012, Poster P

15 Cleopatra: Docetaxel & herceptin ± pertuzumab. Adverse events Adverse event, n (%) Placebo + Herceptin + docetaxel (n=397) Perjeta + Herceptin + docetaxel (n=407) Diarrhea 184 (46.3) 272 (66.8) Constipation 99 (24.9) 61 (15.0) Alopecia 240 (60.5) 248 (60.9) Neutropenia 197 (49.6) 215 (52.8) Nausea 165 (41.6) 172 (42.3) Decreased appetite 105 (26.4) 119 (29.2) Fatigue 146 (36.8) 153 (37.6) Asthenia 120 (30.2) 106 (26.0) Rash 96 (24.2) 137 (33.7) Mucosal inflammation 79 (19.9) 113 (27.8) Peripheral edema 119 (30.0) 94 (23.1) Febrile neutropenia 30 (7.6) 56 (13.8) Dry skin 17 (4.3) 43 (10.6) Green: higher in Perjeta arm Blue: higher in placebo arm J Baselga et al N Engl J Med 2012;366:109-19

16 Cleopatra: Docetaxel & herceptin ± pertuzumab. PFS by prior therapy Placebo + Herceptin + docetaxel Median PFS, months Perjeta + Herceptin + docetaxel Median PFS, months Hazard ratio (CI) Prior (neo)adjuvant Herceptin treatment (n = 88) ( ) No prior (neo)adjuvant Herceptin treatment (n = 288) ( ) PFS, progression-free survival J Baselga et al N Engl J Med 2012;366:109-19

17 Can we avoid all this mucking about with signal transduction? armed Herceptin for HER2+ BC DM1 = microtubule targeting agent Average number DM1 molecules/ monoclonal antibody = 3.5

18 Phase II study of T-DM1 vs trastuzumab + docetaxel in 1st-line HER2-positive MBC HER2-positive MBC No prior chemotherapy for metastatic disease (n=120) T-DM1 Trastuzumab + docetaxel Hurvitz S A et al. JCO 2013;31:

19 T-DM1 vs trastuzumab + docetaxel: response rates Trastuzumab + docetaxel (n=69) a T-DM1 (n=67) Patients with an objective response, b n (%) 40 (58.0) 43 (64.2) 95% CI Objective responses, n (%) Complete response 3 (4.3) 7 (10.4) Partial response 37 (53.6) 36 (53.7) Stable disease 23 (33.3) 13 (19.4) Progressive disease 4 (5.8) 8 (11.9) Unable to evaluate or missing 2 (2.9) 3 (4.5) Patients with clinical benefit, c n (%) 56 (81.2) 50 (74.6) 95% CI Hurvitz S A et al. JCO 2013;31:

20 T-DM1 vs trastuzumab + docetaxel: progression-free survival Hurvitz S A et al. JCO 2013;31:

21 T-DM1 vs trastuzumab + docetaxel: overall survival (interim analysis). Hurvitz S A et al. JCO 2013;31:

22 T-DM1 vs trastuzumab + docetaxel: quality of life (A) Mean change in Functional Assessment of Cancer Therapy- Breast (FACT-B) Trial Outcome Index (TOI) scores from baseline. (B) Kaplan-Meier estimates of time to symptom progression (TOI-PFB [Trial Outcome Index-Physical/Functional/ Breast]). Hurvitz S A et al. JCO 2013;31:

23 EMILIA Study Design HER2-positive LABC or MBC (N=991) Prior taxane and trastuzumab Progression on metastatic treatment or within 6 months of adjuvant treatment 1:1 T-DM1 3.6 mg/kg q3w IV Capecitabine 1000 mg/m 2 PO bid, days 1 14, q3w + Lapatinib 1250 mg/day PO qd PD PD Line of therapy 1 st line 12% 2 nd line 38% 3 rd line 50% Verma et al NEJM :

24 T-DM1 vs Cap+Lap ORR and Duration of Response Objective response rate (ORR) Duration of response (DOR) Patients, % Difference: 12.7% (95% CI, 6.0, 19.4) P= % 120/389 Cap + Lap 43.6% 173/397 T-DM1 Proportion progression-free Median, months (95% CI) Cap + Lap 6.5 (5.5, 7.2) T-DM (8.4, 20.8) Time (months) Verma et al NEJM :

25 Proportion progression-free T-DM1 vs Cap+Lap progression-free survival Median (months) No. of events Cap + Lap T-DM Stratified HR=0.650 (95% CI, 0.55, 0.77) P< Time (months) Unstratified HR=0.66 (P<0.0001). Verma et al NEJM :

26 T-DM1 vs Cap+Lap updated overall survival Median (months) No. of events Cap + Lap Proportion surviving % 85.2% T-DM Stratified HR=0.682 (95% CI, 0.55, 0.85); P= Efficacy stopping boundary P= or HR= % 51.8% Time (months) Data cut-off July 31, 2012; Unstratified HR=0.70 (P=0.0012). Verma et al NEJM :

27 T-DM1 vs capecitabine and lapatinib (EMILIA): patient-reported outcomes The FACT-Breast Trial Outcome Index 1 evaluates Physical Well-Being Functional Well-Being Breast Cancer-Specific Symptoms Symptom progression defined as 5-point decrease from baseline Time to symptom progression Cap + Lap (n=445) T-DM1 (n=450) Median, mos HR (95% CI) P value 0.80 (0.67, 0.95) Brady MJ, et al. J Clin Oncol Blackwell, ASCO

28 TH3RESA Study Schema HER2-positive (central) advanced BC (N=602) 2 T-DM1 3.6 mg/kg q3w IV (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)* (n=200) PD T-DM1 (optional crossover) Median number of prior regimens for MBC =4 (range 1-19) Stable brain metastases in 12% patients TPC:- 83% included HER2-directed therapies 17% single-agent chemotherapy Wildiers ESMO

29 TH3RESA: Overall response rates in patients ORRTH3RESATH3RESA By Investigator Assessment in Patients With Measurable Disease with measurable disease Difference: 22.7% (95% CI, 16.2, 29.2) P< % 30 Patients, % % /163 TPC 108/345 T-DM1 Wildiers ESMO 2013

30 TH3RESA: PFS for Patients Treated With Trastuzumab-Containing Regimens Proportion progression-free TPC (T-containing) (n=149) T-DM1 (n=404) Median (months) No. of events Stratified HR=0.558 (95% CI, 0.437, 0.711) P< Unstratified HR=0.54 (P<0.0001) Time (months) Wildiers ESMO 2013

31 TH3RESA: interim overall survival analysis 1.0 Observed 21% of targeted events Proportion surviving TPC (n=198) Time (months) T-DM1 (n=404) Median (months) 14.9 NE No. of events Stratified HR=0.552 (95% CI, 0.369, 0.826); P= Efficacy stopping boundary HR<0.363 or P< patients in the TPC arm received crossover T-DM1 treatment after documented progression. Unstratified HR=0.57 (P=0.004). Wildiers ESMO 2013

32 Clinical trials in HER2-postitive metastatic breast cancer with gains in PFS ± OS CLEOPATRA (n=808) 1 st -line setting 1 st, 2 nd + 3 rd 3 rd + 4 th TDM4450g (n=137) EMILIA (n=991) EGF (n=291) H+P+T vs H+T T-DM1 vs H+T T-DM1 vs L+C H+L vs L prior herceptin 10% 20% 100% (16%< 6m adj H) CNS disease excluded allowed? n absent or controlled (11%) 100% ( 3 regimens) absent or controlled (12%) 32

33 Clinical trials in HER2-postitive metastatic breast cancer with gains in PFS ± OS CLEOPATRA (n=808) 1 st -line setting 1 st, 2 nd + 3 rd 3 rd + 4 th TDM4450g (n=137) EMILIA (n=991) EGF (n=291) H+P+T vs H+T T-DM1 vs H+T T-DM1 vs L+C H+L vs L prior herceptin 10% 20% 100% (16%< 6m adj H) CNS disease excluded allowed? n absent or controlled (11%) 100% ( 3 regimens) absent or controlled (12%) ORR n/a n/a PFS (months)

34 Clinical trials in HER2-postitive metastatic breast cancer with gains in PFS ± OS CLEOPATRA (n=808) 1 st -line setting 1 st, 2 nd + 3 rd 3 rd + 4 th TDM4450g (n=137) EMILIA (n=991) EGF (n=291) H+P+T vs H+T T-DM1 vs H+T T-DM1 vs L+C H+L vs L prior herceptin 10% 20% 100% (16%< 6m adj H) CNS disease excluded allowed? n absent or controlled (11%) 100% ( 3 regimens) absent or controlled (12%) ORR n/a n/a PFS (months) OS (months) 37.6 NR NR NR ER+ve ER-ve 12 v v 9 OS gain? 12 months NSD 5.8 months 4.5 months toxicity slight increase T-DM1 better T-DM1 better slight increase 34

35 Suggestion for the optimal sequence of anti-her2 therapy in HER2-positive metastatic breast cancer. Trastuzumab naïve or sensitive population (T-free interval>1 year) 1 st line Docetaxel*,trastuzumab & pertuzumab Trastuzumab pre-treated and doubt about sensitivity (T-free interval < 1 year) T-DM1 * data from PERUSE should provide information on the utility of other taxoids 35

36 Suggestion for the optimal sequence of anti-her2 therapy in HER2-positive metastatic breast cancer. Trastuzumab naïve or sensitive population (T-free interval>1 year) 1 st line Docetaxel*,trastuzumab & pertuzumab Trastuzumab pre-treated and doubt about sensitivity (T-free interval < 1 year) T-DM1 2 nd line T-DM1 Lapatinib and Capecitabine * data from PERUSE should provide information on the utility of other taxoids 36

37 Suggestion for the optimal sequence of anti-her2 therapy in HER2-positive metastatic breast cancer. Trastuzumab naïve or sensitive population (T-free interval>1 year) 1 st line Docetaxel*,trastuzumab & pertuzumab Trastuzumab pre-treated and doubt about sensitivity (T-free interval < 1 year) T-DM1 2 nd line T-DM1 Lapatinib and Capecitabine 3 rd line Lapatinib and Capecitabine Lapatinib and Trastuzumab esp ER-ve * data from PERUSE should provide information on the utility of other taxoids 37

38 Suggestion for the optimal sequence of anti-her2 therapy in HER2-positive metastatic breast cancer. Trastuzumab naïve or sensitive population (T-free interval>1 year) 1 st line Docetaxel*,trastuzumab & pertuzumab Trastuzumab pre-treated and doubt about sensitivity (T-free interval < 1 year) T-DM1 2 nd line T-DM1 Lapatinib and Capecitabine 3 rd line Lapatinib and Capecitabine Lapatinib and Trastuzumab esp ER-ve 4 th line Lapatinib and Trastuzumab esp ER-ve Trastuzumab and chemo * data from PERUSE should provide information on the utility of other taxoids 38

39 Questions Does the presence of brain metastases influence this sequence? if symptomatic, treat and use above schedule if asymptomatic,?lap +Cap,?T-DM1 or usual schedule Will results of BOLERO 3 influence this algorithm? improved PFS with the addition of Everolimus to navelbine-trastuzumab (ER ve cohort) 39

40 Conclusions The availability of HER2 directed therapies has had a huge impact on the prognosis of patients with this disease control arm of CLEOPATRA (median OS 37.6m) experimental arm OS not reached? 4 years is a chemotherapy-free strategy feasible (MARIANNE)? The importance of combined and continued HER2 suppression has been confirmed in randomised studies with negligible additional physical toxicity with significant financial toxicity We clearly need to derive biomarkers to identify, those who do NOT need intensive anti-her2 approaches those who are resistant and thereby need novel strategies 40

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