BioPATH: A Study of Biomarker Profiles in Asia Pacific HER2 Breast Cancer Patients Treated with Lapatinib and Other Anti-HER2 Therapy
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1 BioPATH: A Study of Biomarker Profiles in Asia Pacific HER2 Breast Cancer Patients Treated with Lapatinib and Other Anti-HER2 Therapy Soonmyung Paik 1 ; Gyungyub Gong 2 ; Yap Yoon Sim 3 ; Tae- You Kim 4 ; Gerardo Cornelio 5 ; Sung-Bae Kim 2 ; Janice Tsang 6 ; Hyuk-Chan Kwon 7 ; Ng Ting-Ying 8 ; Jungsil Ro 9 1 Samsung Cancer Research Institute, Korea & NSABP, USA; 2 Asan Medical Center, Korea; 3 National Cancer Center, Singapore; 4 Seoul National University Hospital, Korea; 5 San Juan De Dios Hospital, Philippines; 6 Queen Mary Hospital, Hong Kong; 7 Dong-A University Medical Centre, Korea; 8 Tuen Mun Hospital, Hong Kong; 9 National Cancer Center, Korea
2 Primary Hypothesis P95 resistance to trastuzumab but not to lapatinib PIK3CA mutation Loss of PTEN resistance to both trastuzumab and lapatinib Vogel C et al; JJCO 2010 (40):6
3 Study Rationale Test the hypotheses; p95 HER2 is associated with resistance to trastuzumab but not to lapatinib. PTEN loss or PIK3CA mutation is associated with resistance to both drugs. Investigate the frequency of biomarkers in Asian breast cancer population p95her2, PTEN loss, PIK3CA mutation, HER2 mrna
4 Study Design (N=600) Primary diagnosis = HER2+ Breast Ca Recurrence / PD initiation of lapatinib End-of study (8 months FU) medical history prospective Anti-HER2 (trastuzumab) exposure Anti-HER2 (lapatinib) exposure Tumor sample Patient enrolment Second tumor sample, if any (re-biopsy/re-resection) Outcome: progression, any death Objectives: Biomarker profiles (p95, PTEN, PI3KCA, HER2 mrna) of tissue samples (primary & rebiopsy, if any) Clinical correlation (PFS, RR, OS) with lapatinib treatment & prior trastuzumab
5 Patient Eligibility Criteria Inclusion criteria 1. HER2+ MBC currently on, or about to start treatment with lapatinibbased treatment regimen in real world setting. 2. Tumor biopsy specimen available from primary breast cancer diagnosis (or any time before starting on any anti-her2 therapy). 3. < 2 lines of anti-her2 exposure (adjuvant + neo- is considered as 1 line). 4. Consent to release tumor specimen and corresponding clinical data. Exclusion criteria 1. currently on lapatinib or trastuzumab clinical trials, or other experimental anti-her2 agents. 2. Brain metastasis only and are/will be receiving radiotherapy. 3. Second primaries of non-breast origin.
6 Interim Analysis 1 st Interim Per Protocol Plan n = 60 (at least 50 evaluable patients to exclude futility) Futility boundary : < 16% (8/50) p95 positivity Biomarker and Clinical Analyses Central HER2 testing: IHC (Herceptest ), FISH (PathVysion ) Biomarker profiles: p95, PTEN, ER Paired samples: preliminary look at conversion rates Correlation of biomarkers with PFS: lapatinib-based regimens trastuzumab-based regimens PFS definition: progression from start of each anti-her2 regimen given in metastatic setting censored for discontinuation due to reasons unrelated to efficacy (eg. toxicity, financial, etc).
7 Biomarker Assays: p95her2 p95, BioMerrieux/BioTheranostics; U.S. Antibody: Mouse anti- human p95her2 (clone 32H2) IHC Staining: Leica Microsystems; Leica Bond Polymer Refine Detection kit Analysis: p95 positivity is defined as > 30% membrane staining of 611 isoform protein Assay development status: analytical validation completed Clinical validation under finalization p95her2 positive p95her2 negative
8 Biomarker Assays: PTEN PTEN, Asan Medical Centre Antibody: PTEN (Abcam, clone Y184 1:100) IHC Staining: Autostainer (Ventana, Roche); Ultradetection kit as detection system Analysis: Down regulation of PTEN is defined when loss of PTEN is noted compared with normal cells. Negative: 0 T/N IRS ratio 0.67 Positive : 0.67< T/N IRS ratio 1 PTEN positive PTEN negative
9 Patient Demographics Patient Characteristics (n=57) n Median age, years 53 (28-82) Postmenopausal 31 (54%) Estrogen receptor (ER) + 28 (49%) Histology Invasive Lobular Carcinoma Invasive Ductal Carcinoma Others Site of metastasis at study entry Local recurrence Contra-lateral breast Regional lymph nodes Distant metastasis 1 (2%) 54 (95%) 2 (3%) 4 (7%) 4 (7%) 7 (12%) 57 (100%)
10 Central confirmation of HER2 positivity IHC HercepTest (n=57, missing=3, tested=54) 0 1/54 (2%) 1 2/54 (4%) 2 9/54 (17%) 3 42/54 (78%) FISH Pathvysion (n=57, missing=7, tested=50) negative 5/50 (10%) positive 45/50 (90%) FISH ratio 0-2 5/50 (10%) /50 (46%) > 5 22/50 (44%) FISH positivity: 10% discordance rate between central & local labs 5 samples negative by both assays
11 Patient Cohort First Patient enrolled: 17 Aug 2010 Clinical Data cut-off: 12 Aug 2011 Countries: South Korea (43) Hong Kong (13) Philippines (1) Singapore (3) p95 n=53* Paired samples n = 12 Enrolled n = 60 PTEN n=50* Excluded: 3 missing 1⁰ sample ER n=56* Did not cross futility threshold defined for interim analysis (p95 expression rate of < 16%) p /53 (55%) PTEN + 29/50 (58%) ER + 28/56 (50%) p95 PTEN ER 24/53 (45%) 21/50 (42%) 28/56 (50%) *Tissue quantity or quality insufficient for some assays, hence total n for each biomarker differs
12 p95 expression by HER2, PTEN & ER status HER2 IHC Score n=51 HER2 FISH ratio n=49 PTEN n=48 ER n=52 p95 +ve p95 -ve 0 0 (0%) 1 (2%) 1 0 (0%) 0 (0%) 2 1 (2%) 8 (16%) 3 28 (55%) 13 (25%) (0%) 4 (8%) (20%) 13 (27%) > 5 18 (37%) 4 (8%) +ve 16 (33%) 13 (27%) -ve 12 (25%) 7 (15%) +ve 12 (23%) 14 (27%) -ve 17 (33%) 9 (17%) Chisquare P value p95 expression correlates with HER2 amplification/overexpression
13 BioPATH: Paired Samples Cohort (n=12) Subject # 1⁰ Sample 2⁰ Sample Remarks K0204 p95 + PTEN+ p95 + PTEN+ both biomarkers conserved H0105 p95 + PTEN + p95 + PTEN + both biomarkers conserved K0803 p95 + PTEN - p95 + NA 2⁰ sample - no normal tissue for PTEN H0405 p95 + PTEN - p95 + NA 2⁰ sample - no normal tissue for PTEN H0404 p95 + PTEN- N/A PTEN- 1⁰ sample - quantity not sufficient for p95 K0402 p95 + PTEN + p95 - PTEN + p95 conversion K0209 p95 + PTEN + p95 + PTEN - PTEN conversion H0106 p95 - PTEN - p95 + PTEN - p95 conversion (reverse) K0502 p95 - PTEN - p95 - PTEN + PTEN conversion (reverse) H0406 p95 - PTEN + p95 + PTEN - 1⁰ sample - No fluorescence signal (FISH); p95 & PTEN conversion K1001 p95 - PTEN- p95 - PTEN- both biomarkers conserved H0104 p95 - N/A p95 - PTEN- 1⁰ sample - no normal tissue for PTEN p95 expression and PTEN mutation mainly de novo but small proportion could possibly be acquired (single or double conversion). No HER2 conversion was detected.
14 PFS of anti-her2 treatment (trastuzumab, lapatinib) for MBC by p95 positivity Trastuzumab Lapatinib p95 n No. of events Negative Positive p95 n No of events Negative Positive p = p =
15 PFS of anti-her2 treatment (trastuzumab, lapatinib) for MBC by PTEN expression Trastuzumab Lapatinib PTEN n N of events Negative Positive PTEN n N of events Negative Positive p = p =
16 PFS of anti-her2 treatment (trastuzumab, lapatinib) for MBC by ER Trastuzumab Lapatinib ER n N of events Negative Positive ER n N of events Negative Positive p = p =
17 Subject ID * * * K1001 S0101 K0801 K1202 K1106 K0102 K0208 K0210 P0201 K0803 K1103 K0502 K0701 K0401 H0102 K0104 S0103 K1104 K0204 K0804 K0503 K0103 H0401 K0105 K0904 H0108 H0105 H0405 K0802 H0101 K0903 H0404 H0402 K1105 H0106 H0403 K1101 K1102 H0103 H0406 K0901 K1201 K0109 K0108 K0205 H0104 K0501 K0110 K0207 K0101 K0106 S0102 K0702 K0902 K0203 K0206 K0209 K0202 K0107 K0201 K0402 K0111 Anti-HER2 exposures by patients in metastatic setting Trastuzumab-based regimen Lapatinib-based regimen non anti-her2 regimen Current regimen still ongoing * Pts who are HER2 negative by central lab Treatment Duration (weeks)
18 Study Limitations Interim cohort small sample size interpret results with caution Interim analysis not powered to detect biomarker by treatment effect Pre-selection bias: lapatinib-treated group patients with opportunity to be treated with other anti-her2 Data still immature for lapatinib-treated patients as some are still on ongoing treatment
19 Summary & Conclusion 10% HER2 discordance rate between central and local labs this is within commonly reported range of % 1,2. Quality of HER2 testing in Asian countries is highly acceptable. > half was p95+ (55%) threshold for study futility not reached, hence study will continue recruiting. Paired samples (n=12) No conversion for HER2 status detected Single conversion: p95 (2/11), PTEN (2/9) Double conversion: p95 & PTEN (1/12) No significant difference in PFS observed by p95, PTEN & ER status on lapatinib or trastuzumab early trends to be confirmed Predictive value of p95 & PTEN in metastatic breast cancer setting remains to be confirmed. 1 Perez et al, JCO 2006; 2 Wolf et al. Arch Pathol Lab Med 2007
20 Acknowledgements We would like to thank the following for their contribution to BioPATH study: BioMerrieux US: Jean-Marie Bruey - p95 assay scientist Asan Medical Centre: Dr. Hee Jin Lee - PTEN assay Samsung Clinical Research Institute: Dr In-Gu Do: central lab HER2 assays (FISH & IHC) pathologist Dr Insuk Sohn: statistician GlaxoSmithKline Asia Pacific Oncology: Dr Hanlim Moon: study sponsor & medical monitor Ee-Min Yeoh: project leader & scientific writer (protocol/abstract/slides) Ji-Yeon Cha: study operations manager & tissue sample management Parexel International Co., Ltd data management AND all the investigators and patients of the study
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