TNBC: What s new Déjà vu All Over Again? Lucy R. Langer, MD MSHS Compass Oncology - SABCS 2016 Review February 21, 2017

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1 TNBC: What s new Déjà vu All Over Again? Lucy R. Langer, MD MSHS Compass Oncology - SABCS 2016 Review February 21, 2017

2 The problem with TNBC 1. Generally more aggressive 2. ONLY chemotherapy 3. No other proven targets

3 In Subtyping TNBC 2. Platinums 3. PARP-inhibitors 4. Clinical Trials

4 What s new in 2016? 1. Prevention of TNBC 2. More on TNBC subtyping 3. AR, a potential new target 4. BRCA -ness 5. Tumor infiltrating lymphocytes & a brief word on the PD-1 inhibitors

5 Prevention

6 Prevention PolyphenonE (active agent in green tea) Metformin HER-2 Strategies DHEA: omega-3 fatty acids DCIS trastuzumab trials Lapatinib in mouse, now being evaluated in women VADIS trial: HER2 peptide vaccine retinoids statins

7 What s new in 2016? 1. Prevention of TNBC 2. More on TNBC subtyping 3. AR, a potential new target 4. BRCA -ness 5. Tumor infiltrating lymphocytes & a brief word on the PD-1 inhibitors

8 Triple Negative Subtyping 70-80% Basal-like 20-30% Luminal/AR type

9 What s new in 2016? 1. Prevention of TNBC 2. More on TNBC subtyping 3. AR, a potential new target 4. BRCA -ness 5. Tumor infiltrating lymphocytes & a brief word on the PD-1 inhibitors 6. Neoadjuvant and post-neoadjuvant

10

11 Luminal/AR type TNBC Enriched in hormonal pathways, like the Androgen Receptor HER2-enriched, even though HER2 negative Bicalutamide, a prostate drug, no benefit Enzalutamide, some benefit predicted by Predict-AR Lapatinib shows possible benefit

12

13 What s new in 2016? 1. Prevention of TNBC 2. More on TNBC subtyping 3. AR, a potential new target 4. BRCA -ness 5. Tumor infiltrating lymphocytes & a brief word on the PD-1 inhibitors

14

15 Basal-Like TNBC Most BRCA1 breast cancers are Basal-Like Basal-Like breast cancers have DNA repair defects like BRCA1 Carboplatin shows some promise in BRCA+ cancers Parp inhibitor Olaparib shows effect in BRCA+ cancer HRD test not predictive of BRCA-ness

16

17 What s new in 2016? 1. Prevention of TNBC 2. More on TNBC subtyping 3. AR, a potential new target 4. BRCA -ness 5. Tumor infiltrating lymphocytes & a brief word on the PD-1 inhibitors

18

19

20 What about PD-1? 10-15% of TNBC falls into the immunomodulatory subtype Enriched immune processes, TILs Higher expression of PDL-1 Atezolizumab (Tecentriq) + nab-paclitaxel Pembrolizumab Awaiting RCTs

21

22 Conclusions TNBC subtyping tools are nearly ready TNBC is chemo-sensitive, biomarkers such as Basal/non, TILs, and HRD signature are emerging Many promising new drugs exist and are being tested (AR blockers, lapatinib, immune modulators, etc)

23

24 What s new in 2016? 1. Prevention of TNBC 2. More on TNBC subtyping 3. AR, a potential new target 4. BRCA -ness 5. Tumor infiltrating lymphocytes & A brief word on the PD-1 inhibitors

25 Neoadjuvant therapy in TNBC GeparSixto: Phase II chemo/bev +/- carbo % vs 53.2% pcr, slight incr DFS CALGB 40603: Phase II chemo+/-bev+/- carbo - 41% vs. 64% pcr, no DFS or OS benefit at 5 years What increase in pcr is needed to translate into DFS or OS?

26 Post-neoadjuvant treatment trials Japan: CREATE-X trial - Capecitabine vs. obs/endocrine - Benefit appears limited to TNBC, requires HIGH chemo doses PAM50 Analysis basal-like has worse prognosis in nonpcr group ECOG-ACRIN EA1131 SWOG Phase III, platinum vs. obs in Basal TNBC - Phase III pembrolizumab for TNBC post-neo or adjuvant

27 CREATE-X: Study Design Stratified by ER status, age, neoadjuvant chemotherapy, use of 5-FU, institution, node status Preplanned interim analysis of a randomized, open-label phase III study [1] Pts yrs of age with stage I-IIIB HER2- BC and residual disease (non-pcr, N+) after neoadjuvant chemotherapy* and surgery; ECOG PS 0 or 1; no previous oral fluoropyrimidines (N = 910) Primary endpoint: DFS Wk 24 Capecitabine 2500 mg/m²/day PO Days 1-14 Q3W for 8 cycles Hormonal therapy if ER/PgR+ (n = 455) Hormonal therapy if ER/PgR+ No further therapy if ER/PgR- (n = 455) Secondary endpoints: OS, time from first day of preoperative chemotherapy to recurrence or death, safety, cost-effectiveness *Anthracycline/taxane, anthracycline containing, or docetaxel/cyclophosphamide. 25 pts were removed from treatment (n = 10) and control (n = 15) arms due to failure to meet eligibility criteria. IDMC recommended extension to 8 cycles following interim safety analysis of first 50 pts receiving 6 cycles. [2] 1. Toi M, et al. SABCS Abstract S Ohtani S, et al. SABCS Abstract P Slide credit: clinicaloptions.com

28 CREATE-X: 5-Yr Efficacy Capecitabine achieved significantly higher 5-yr DFS and OS in HER2- BC pts with residual disease Characteristic, % Capecitabin e (n = 440) No Capecitabin e (n = 445) 5-yr DFS yr OS HR (95% CI) 0.70 ( ) 0.60 ( ) P Value <.01 Toi M, et al. SABCS Abstract S1-07. Slide credit: clinicaloptions.com

29 CREATE-X: DFS by Subgroup Subgroup HR (95% CI) Total (N = 885) 0.70 ( ) Age < 50 yrs (n = 531) 50 yrs (n = 354) Hormone receptor status Positive (n = 561) Negative (n = 296) Node stage ypn0 (n = 345) ypn1 (n = 339) ypn2 or 3 (n = 199) Path grade by NAC 0-1b (n = 482) 2-3 (n = 385) 0.72 ( ) 0.68 ( ) 0.84 ( ) 0.58 ( ) 0.88 ( ) 0.54 ( ) 0.82 ( ) 0.63 ( ) 0.84 ( ) Subgroup HR (95% CI) Total (N = 885) 0.70 ( ) Taxane-containing NAC Yes (n = 849) No (n = 36) 5-FU containing NAC Yes (n = 529) No (n = 356) Nationality Japanese (n = 599) Korean (n = 286) 0.70 ( ) 0.87 ( ) 0.74 ( ) 0.65 ( ) 0.74 ( ) 0.63 ( ) Toi M, et al. SABCS Abstract S1-07. Slide credit: clinicaloptions.com

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