7/7/2014
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`Abstract Search - European Cancer Congress 2013
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`The European Cancer Congress 2013
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`Abstract Search - European Cancer Congress 2013
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`Session title: Breast Cancer - Advanced Disease
`Session type: Proffered Papers Session
`Track: Breast Cancer - Early and Advanced Disease
`Abstract number: 15
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`LATE BREAKING ABSTRACT: T-DM1 for HER2-positive metastatic breast cancer (MBC): Primary results
`Abstract title:
`from TH3RESA, a phase 3 study of T-DM1 vs treatment of physician's choice
`
`H. Wildiers(1), S.B. Kim(2), A. Gonzalez-Martin(3), P.M. LoRusso(4), J.M. Ferrero(5), M. Smitt(6), R. Yu(6), A. Leung(6), I.E. Krop(7)
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`(1)University Hospitals Leuven, Department of General Medical Oncology/Multidisciplinary Breast Centre, Leuven, Belgium
`(2)Asan Medical Center/University of Ulsan College of Medicine, Department of Oncology, Seoul, Korea
`(3)Centro Oncológico MD Anderson International España, Medical Oncology Department, Madrid, Spain
`(4)Karmanos Cancer Institute Wayne State University, Department of Internal Medicine, Detroit, USA
`(5)Centre Antoine Lacassagne, Department of Medical Oncology, Nice, France
`(6)Genentech Inc., N/A, South San Francisco, USA
`(7)Dana-Farber Cancer Institute Breast Oncology Center, Harvard Medical School, Boston, USA
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`Background: T-DM1, an antibody-drug conjugate comprising the cytotoxic agent DM1 linked to trastuzumab, is approved in the US for patients (pts)
`with MBC previously treated with trastuzumab and a taxane. There is no clear standard of care for pts with progressive disease (PD) after ≥2 HER2-
`directed regimens for MBC. TH3RESA is an ongoing phase 3 study evaluating T-DM1 vs treatment of physician’s choice (TPC) in this pt population
`(NCT01419197; Genentech, a member of the Roche Group).
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`Methods: Pts with centrally confirmed HER2-positive unresectable locally advanced BC or MBC with PD after ≥2 HER2-directed regimens, including
`trastuzumab and lapatinib, in the unresectable recurrent/metastatic setting and a taxane (any setting) were randomized 2:1 to T-DM1 (3.6 mg/kg IV q3w)
`or TPC. Co-primary endpoints were progression-free survival (PFS) by investigator and overall survival (OS). After EMILIA data were reported,
`crossover from TPC to T-DM1 was allowed post-progression.
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`Results: At the 11 Feb 2013 cutoff, 602 pts were randomized; 44 pts in the TPC arm had crossed over to T-DM1. TPC comprised HER2-directed
`regimens (83.2%) and single-agent chemotherapy (16.8%). Pts had received a median of 4 prior regimens (excluding hormonal therapy) in the
`recurrent/metastatic setting, and the majority (75.1%) had visceral disease. PFS and objective response rate (ORR) were significantly improved with T-
`DM1; the interim OS analysis showed a similar trend, but the stopping boundary was not crossed (Table). PFS benefit was consistent across subgroups,
`including age, visceral involvement, number of prior regimens, and TPC type. The T-DM1 safety profile was consistent with prior studies. Fewer grade
`≥3 adverse events (AEs) overall were reported for T-DM1 vs TPC (32.3% vs 43.5%). More grade ≥3 thrombocytopenia (4.7% vs 1.6%) was reported
`with T-DM1. More grade ≥3 neutropenia (2.5% vs 15.8%), febrile neutropenia (0.2% vs 3.8%), and diarrhea (0.7% vs 4.3%) were reported with TPC.
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`T-DM1
`n=404
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`TPC
`n=198
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`PFS, median mos
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`6.2
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`3.3
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`HR (95% CI)
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`0.528 (0.422, 0.661)
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`P value
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`<.0001
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`http://eccamsterdam2013.ecco-org.eu/Scientific-Programme/Abstract-search.aspx?abstractid=8879
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`IMMUNOGEN 2009, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`7/7/2014
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`Abstract Search - European Cancer Congress 2013
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`Interim OS, median mos Not reached
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`14.9
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`HR (95% CI)
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`0.552 (0.369, 0.826)
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`P value
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`.0034
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`Stopping boundary: HR=0.363
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`T-DM1
`n=345
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`TPC
`n=163
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`ORR, % (95% CI)
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`31.3 (26.5, 36.5) 8.6 (5.1, 13.8)
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`Difference, % (95% CI)
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`22.7 (16.2, 29.2)
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`P value
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`<.0001
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`Conclusions: T-DM1 resulted in a statistically significant improvement in PFS, with fewer grade ≥3 AEs than TPC in pts previously treated with ≥2
`HER2-directed regimens for HER2-positive MBC.
`Keywords:
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`Amsterdam
`2013
`ECCO
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`http://eccamsterdam2013.ecco-org.eu/Scientific-Programme/Abstract-search.aspx?abstractid=8879
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`2/2
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`IMMUNOGEN 2009, pg. 2
`Phigenix v. Immunogen
`IPR2014-00676
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