Post-ESMO 2012: Tamara Rordorf Klinik für Onkologie UniversitätsSpital Zürich T.Rordorf, SAMO Luzern 1

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1 Post-ESMO 2012: Breast Cancer Tamara Rordorf Klinik für Onkologie UniversitätsSpital Zürich 1

2 Neoadjuvant treatment (in Her-2 positive disease) neoadjuvant trials abstracts: breast sparing surgery, biomarkers, anthracyclines controversy session Adjuvant treatment duration of trastuzumab treatment Her-2 positive patients (HERA 2-y update, PHARE) Metastatic disease trials: Cerebel, Emilia, Turandot, Bolero-2 2

3 Neoadjuvant treatment for Her-2 positive EBC: NOAH trial Phase 3 trial; n=424 Primary endpoint: EFS Secondary endpoints: pcr, ORR, cardiac safety, OS Results (T vs no T): EFS: 71% vs 56%; HR 0.59, p=0.013 pcr rate 43 vs 22%, p=

4 Neoadjuvant treatment for Her-2 positive EBC: GeparQuattro Phase 3 trial, n= 445 Primary endpoint: pcr Secondary endpoints: rate of breast conservation, RR at surgery, toxicity Results: pcr: 31.8% (Her2+) vs 15.4% (Her2- No cardiac safety concerns 4

5 Neoadjuvant treatment in Her-2 positive EBC:GeparQuinto Phase 3 randomized trial; n=620 Primary endpoint: pcr Secondary endpoints: toxicity, RR, BCS Results: pcr: (T) vs 21.7 (L); HR 0.68; p<0.047 No difference in clinical RR before surgery More toxicity and dose reduction in L Arm 5

6 Neoadjuvant treatment for Her-2 positive EBC: NeoALTTO Randomized phase 3 trial, n=450 Primary endpoint: rate of pathological complete response (pcr) Secondary endpoints (neoadjuvant part): locoregional total pcr, RR at the end of the biological window and at the time of surgery; BCS&rate of conversion to BCS Secondary endpoints: DFS, OS, molecular characteristics of responding tumors, biomarkers 6

7 Neoadjuvant treatment for Her-2 positive EBC: NeoALTTO pcr combination group (dual blockade) (51.3%) > mono T or L L group (24.7%) = T group (29.5%) HR neg. > HR positive Clinical response: Biological agents+ chemo>biologicals alone No major cardiac dysfunctions 7

8 Neoadjuvant treatment for Her-2 positive EBC: NeoSphere Phase II trial, n= 417 Primary endpoint: pcr in breast Secondary endpoints: clinical objective response, BCS, time to clinical response, safety Pertuzumab binds to domain II of the HER2 receptor Complementary mechanism of action to trastuzumab inhibits heterodimerisation of Her2 with Her1, Her 3 and Her4 8

9 Neoadjuvant treatment for Her-2 positive EBC: NeoSphere pcr: Dual blockade>single agents Biological agents+chemo> biological agents alone HR neg>hr pos 9

10 Neoadjuvant trials for Her-2 positive EBC What the trials showed.. Discussion topics pcr matters in Her2 positive disease! pcr & rate of breast conserving surgery pcr more likely to be achieved: dual blockade > single biological agent biological agent + chemo > biolog. alone In HR negative > HR positive pcr and biomarkers Neoadjuvant trials and accelerated early drug approval And Is combining biological agents and anthracylines safter than initially thought?? 10

11 Discrepancy between high pcr and BCS in neoaltto (Abstract 2470) High rate of pcr does not translate in higher rate of BCS (yet) ( GeparQuattro BCS rate: 64% but 21% of patient with mastectomy had pcr after surgery!) Solution? Biological markers (Ki67 after 1 st cycle ) for planning the surgery according the markers for pcr?) 11

12 NETT Trial: neoadjuvant TC vs. TAC in Her-2 positive and TNBC (Abstr. 320) Phase II trial; n=102 6x TC vs 6x TAC 50% of patients Her2-pos Primary endpoint: pcr Secondary endpoints: DFS, EFS, OS, BCS, CRR, safety Results: pcr: 17.6% vs 6.8% EFS: TAC>TC, p=0.012 (NSABP B-49 awaited) 12

13 Neoadjuvant trials and accelerated drug approval (Controversy Session) Pro speaker (Prof. Baselga) Contra speaker (Prof. Tannock) Shorter, smaller trials -> results faster ->patients benefit faster -> pcr is a surrogate marker for DFS/OS Safety of new drugs in small trials? Examples: Hera vs. NOAH ALTTO vs. NeoALTTO If confirmatory trial requiered, who will participate if drug already approved? Is response to therapy reasonably likely to predict survival benefit? In some cases, neoadjuvant and adjuvant data are consistant. In others, they are not! 13

14 HERA trial: 2 years vs. 1 year of trastuzumab after adjuvant chemotherapy at 8 years of median follow up (LBA 6-PR) 14

15 HERA trial: 2 years vs. 1 year of trastuzumab after adjuvant chemotherapy at 8 years of median follow up (LBA 6-PR) 15

16 HERA trial: 2 years vs. 1 year of trastuzumab after adjuvant chemotherapy at 8 years of median follow up (LBA 6-PR) 16

17 HERA trial: 2 years vs. 1 year of trastuzumab after adjuvant chemotherapy at 8 years of median follow up (LBA 6-PR) 17

18 PHARE trial:6 vs. 12 months of adjuvant trastuzumab in EBC (LBA5_PR) Rationale: 1 year of adjuvant trastuzumab improves DFS/OS 9 weeks of adjuvant trastuzumab provided similar benefit Primary objective: To compare the effect of 6 vs 12 moths in terms of DFS Secondary objectives: cardiotoxicity, distant metastases free survival OS Non-inferiority trial 95% CI HR margin should not cross boundry 18

19 PHARE trial:6 vs. 12 months of adjuvant trastuzumab in EBC (LBA5_PR) 19

20 PHARE trial:6 vs. 12 months of adjuvant trastuzumab in EBC (LBA5_PR) Results: Inconclusive for non-inferiority Trend favouring 12 months treatment Significant difference in cardiac events ->12 months remains standard 20

21 Metastatic breast cancer: Update EMILIA Trial (LBA 12) Trastuzumab emtansine (T-DM1) - antibody drug conjugate (trastuzumab, linker, cytotoxic antitubulin agent DM1) - intracellular drug delivery to Her-2 overexpressing cells 21

22 Metastatic breast cancer: Update EMILIA Trial (LBA 12) Results: PFS: 9.6 vs 6.4 months, HR 0.65, p<0.001 OS at 2nd interim analysis: 30.9 vs 25.1 months, HR 0.68, p< RR 43.6% vs. 30.8%, HR 0.68, p> year survival rates 85.2% vs.78.4% 22

23 Metastatic breast cancer: Update EMILIA Trial (LBA 12) Toxicity:(Grad 3&4) T-DM1: Thrombocytopenia : 12.9%; AST/ALT, Anemia Lap/Cap: Diarrhea, hand-foot sy, vomiting, neutropenia, hypokalemia) 23

24 Metastatic breast cancer: Cerebel Trial (LBA11) Background: Her2+ patients have high incidence of brain metastases (28-40%) Lapatinib/capecitabine demostrated lower rate of CNS metastases Primary endpoint: incidence of brain metastases as first site of relapse Secondary endpoint: PFS; OS, brain metastases at any time Stratification according to previous exposure to herceptin 20% of patients excluded after asymptomatic brain metatases were found in screening-mr 24

25 Metastatic breast cancer: Cerebel Trial (LBA11) Results: Low incidence of brain metastases in both arms Primary end point: inconclusive PFS better in patients treated with trastuzumab and capecitabine (8 vs. 6.6 months) in the trastuzumab/cap group; PFS better in the patients who were not treated with trastuzumab previously (dipicted) no difference between two arms for trastuzumab-pretreated patients 25

26 Metastatic breast cancer: Turandot trial (LBA3170) Background: No standard for 1st line treatment Both E2100 (bevacizumab+paclitaxel) and RIBBON-1 (bev+capecitabine) trial showed improvement in PFS in 1st line when bevacizumab added to chemo Capecitabine and bevacizumab randomized against paclitaxel and bevacizumab in first line Primary end-point: non-inferior OS Secondary end-points: PFS; RR, time to response, duration of response, TTF 26

27 Metastatic breast cancer: Turandot trial (LBA3170) Summary: The criterion for OS- non-inferiority has not been met Interim OS data show not relevant differences PFS and RR significantly better with bevpac 27

28 Effect of everolimus on visceral metastases in BOLERO-2 (324) Bolero-2: Efficacy and safety of everolimus in postmenopausal women with advanced, HR pos, Her-2 neg BC refractory to NSAI Previous therapy: NSAI (100%), tamoxifen(48), fulvestrant (16),chemotherapy (68%) Stratification: visceral disease y/n PFS: (at follow up of 18 months) 7.8 vs 3.2 months; HR 0.45, P< FDA and EMA approval 28

29 Effect of everolimus on visceral metastases in BOLERO-2 PFS (pts with visceral metastases): 6.8 vs 2.67 PFS (pts with bone metastases only): 9.86 vs

30 Effect of everolimus on visceral metastases in BOLERO-2 Toxicity SAE 23% combination arm vs. 12% in controll arm Discontinuation: 19% vs. 4 % G3/4 AE: stomatitis (85 vs. 1%), anemia, dyspnoa, hyperglicemia Who are the patients that benefit? Patients who acquire endocrine resistance following prior hormonal responsiveness ER positive tumor cells acquire PI3K driven survival pathway and become primed to respond to combination of mtor inhibitor and exemestane Such pathway is absent in untreated patienst and those patients are unlikely to benefit from addition of mtor inhibitor in first-line treatment 30

31 THANK YOU 31

32 REMAGUS04 Trial Is whole genome array feasible in the context of daily practice? Evaluate Topo-2A amplification as a predictor for efficacy of anthracyclin-based therapy Could DLD-30 be used as a predictor of resistance to chemotherapy? Could combined use of genomic score (DLD 30) and Topo-2A level improve efficacy of neoadjuvant chemotherapy? 32

33 REMAGUS04 Trial Primary endpoint: Could genomic driven chemotherapy improve rate of pcr when compared to standard chemotherapy 33

34 REMAGUS04 Trial 34

35 REMAGUS04 Trial 35

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