Triple Negative Breast Cancer - MECCmeccinc.com/wp-content/uploads/2018/08/1010_CHEW... · AZD5363...
Transcript of Triple Negative Breast Cancer - MECCmeccinc.com/wp-content/uploads/2018/08/1010_CHEW... · AZD5363...
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Triple Negative Breast Cancer
Helen K. Chew, MDProfessor of Medicine
Division of Hematology/Oncology
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13th Annual New Orleans Summer Cancer MeetingJuly 20-22, 2018
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Today’s talk• Classification of triple negative breast cancers
(TNBC)• Review current standard and emerging
therapies• BRCA-mutated breast cancer• Current trials
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Triple negative breast cancers• Lack expression of ER, PgR or HER (non
amplified)• 15-20% of all breast cancers• Clinically aggressive• No “targeted” therapy proven
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Triple negative breast cancers
Prat and Perou, Molec Oncol 2010
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Triple negative breast cancers
• Platinum agents, DNA repair• PI3K and MEK pathways• Checkpoint inhibitors• Androgen receptor
Prat and Perou, Molec Oncol 2010
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Triple negative breast cancers• Metastatic: platinum agents incorporated
sequentially• Neoadjuvant: consider adding carboplatin for
pCR; capecitabine?• Adjuvant: no data that additional agents
improve DFS or OS
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NRG BR003
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SWOG 1416 in TNBC or BRCA-mutated
PI: Eve Rodler, MD
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AZD5363 plus Paclitaxel versus Placebo plus Paclitaxel as first-line therapy for metastatic triple-negative breast cancer (PAKT): A randomised, double-blind, placebo-controlled, phase II trial.
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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Background
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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PAKT Study Design
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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Safety: Reported Adverse Events
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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PFS by investigator assessment (ITT)
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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Overall Survival (ITT Population)
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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PFS by tumour PIK3CA/AKT1/PTEN status
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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Overall Survival by PIK3CA/AKT1/PTEN status
Presented By Peter Schmid at 2018 ASCO Annual Meeting
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Ipatasertib: selective targeting of AKT
Presented By Rebecca Dent at 2018 ASCO Annual Meeting
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LOTUS (NCT02162719) randomized phase II trial
Presented By Rebecca Dent at 2018 ASCO Annual Meeting
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Primary analysis: IPAT effect on PFS enhanced in PIK3CA/AKT1/PTEN-altered subgroup (Foundation Medicinea)
Presented By Rebecca Dent at 2018 ASCO Annual Meeting
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OS in the ITT population
Presented By Rebecca Dent at 2018 ASCO Annual Meeting
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OS according to IHC PTEN status (Ventana)
Presented By Rebecca Dent at 2018 ASCO Annual Meeting
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Updated safety: Most commona adverse events (all grades)
Presented By Rebecca Dent at 2018 ASCO Annual Meeting
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S1418
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Rationale for Niraparib (PARPi) + anti-PD-1 Combination
Presented By Shaveta Vinayak at 2018 ASCO Annual Meeting
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TOPACIO Phase 2 Design
Presented By Shaveta Vinayak at 2018 ASCO Annual Meeting
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Best Overall Response and Objective Response Rate (ORR)
Presented By Shaveta Vinayak at 2018 ASCO Annual Meeting
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Biomarker Status for Efficacy Evaluable Patients (N=46)
Presented By Shaveta Vinayak at 2018 ASCO Annual Meeting
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Biomarker-Selected Populations
Presented By Shaveta Vinayak at 2018 ASCO Annual Meeting
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Observed Best Responses
Presented By Shaveta Vinayak at 2018 ASCO Annual Meeting
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Table 2. Clinical Benefit
Published in: Tiffany A. Traina; Kathy Miller; Denise A. Yardley; Janice Eakle; Lee S. Schwartzberg; Joyce O’Shaughnessy; William Gradishar; Peter Schmid; Eric Winer; Catherine Kelly; Rita Nanda; Ayca Gucalp; Ahmad Awada; Laura Garcia-Estevez; Maureen E. Trudeau; Joyce Steinberg; Hirdesh Uppal; Iulia Cristina Tudor; Amy Peterson; Javier Cortes; JCO 2018, 36, 884-890.DOI: 10.1200/JCO.2016.71.3495Copyright © 2018 American Society of Clinical Oncology
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Fig 2. Kaplan-Meier plots of primary analysis of progression-free survival (PFS) in the (A) intent-to-treat (ITT) population and (B) evaluable subgroup and of overall survival (OS) in the (C) ITT population and (D) evaluable subgroup.
Published in: Tiffany A. Traina; Kathy Miller; Denise A. Yardley; Janice Eakle; Lee S. Schwartzberg; Joyce O’Shaughnessy; William Gradishar; Peter Schmid; Eric Winer; Catherine Kelly; Rita Nanda; Ayca Gucalp; Ahmad Awada; Laura Garcia-Estevez; Maureen E. Trudeau; Joyce Steinberg; Hirdesh Uppal; Iulia Cristina Tudor; Amy Peterson; Javier Cortes; JCO 2018, 36, 884-890.DOI: 10.1200/JCO.2016.71.3495Copyright © 2018 American Society of Clinical Oncology
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BRCA-mutated breast cancers• Most gBRCAm carriers will develop TNBC, but
most TNBC are not in gBRCAm carriers
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Study Design: EMBRACAPrimary endpoint• Progression-free survival by RECIST by central
review
Key secondary efficacy endpoints • Overall survival • ORR by investigator• Safety
Exploratory endpoints • Duration of response (DOR) for objective
responders• Quality of life (QoL; EORTC QLQ-C30,
QLQ-BR23)Phase 3, international, open-label, randomized study conducted in 16 countries and 145 sites
Patients with locally advanced or metastatic HER2-negative breast cancer and a germline BRCA1 or BRCA2 mutation*†
Stratification factors:
• Number of prior chemo regimens (0 or ≥ 1)
• TNBC or hormone receptor positive (HR+)
• History of CNS mets or no CNS mets
Talazoparib1 mg PO daily
Physician's choice of therapy (PCT)‡:capecitabine,
eribulin, gemcitabine,or vinorelbine
R2:1
Treatment (21-day cycles) continues until progression or
unacceptable toxicity
This AACR-SABCS 2017 presentation is the intellectual property of the authors/presenters. Contact [email protected] for permission to reprint and/or distribute.
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Primary Endpoint: PFS by Central ReviewTALA
(n = 287)Overall PCT
(n = 144)
Events, no. (%) 186 (65%) 83 (58%)
Median, mo (95% CI) 8.6 (7.2-9.3) 5.6 (4.2-6.7)
Hazard ratio, 0.54, 95% CI, 0.41-0.71P < .0001
TALAOverall PCT
This AACR-SABCS 2017 presentation is the intellectual property of the authors/presenters. Contact [email protected] for permission to reprint and/or distribute.
Litton et al. EMBRACA: A phase 3 trial comparing talazoparib, an oral PARP inhibitor, to physician’s choice of therapy in patients with advanced germline BRCA-mutation breast cancer. Abs. GS6-07.
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Kaplan–Meier Estimates of Progression-free Survival and Overall Survival.
Robson M et al. N Engl J Med 2017;377:523-533
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Slide 8
Presented By Jennifer Litton at 2018 ASCO Annual Meeting
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Study Design
Presented By Jennifer Litton at 2018 ASCO Annual Meeting
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Pathologic Results
Presented By Jennifer Litton at 2018 ASCO Annual Meeting
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Pathologic Results- Number of Patients
Presented By Jennifer Litton at 2018 ASCO Annual Meeting
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Conclusions• Continued unmet need in heterogenous TNBC• PARP inhibitors in BRCA-mutated cancers
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