LBA15 Primary outcome of the phase III SYD985.002/TULIP trial comparing [vic-]trastuzumab duocarmazine to physician’s choice treatment in patients with pre-treated HER2-positive locally advanced or metastatic breast cancer

Manich, C. Saura; O’Shaughnessy, Joyce; Aftimos, Philippe; Tweel, Evelyn van den; Oesterholt, Mayke; Escrivá-de-Romaní, Santiago; Tueux, N. Quenel; Tan, Tao; Lim, Joline Si Jing; Ladoire, Sylvain; Armstrong, Anne; Crook, Tim; Stradella, Agostina; Bianchi, Giulia; Mulder, Renée L.; Koper, N.P.; Turner, Nicholas

doi:10.1016/j.annonc.2021.08.2088

Cited by 96 publications

(78 citation statements)

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“…Similarly, trastuzumab-duocarmazine demonstrated interesting clinical activity in HER2-positive metastatic breast cancer patients in the phase I study (ORR 28% in HR-positive and 40% in HR-negative HER2-low metastatic breast cancer) ( Banerji et al, 2019 ). The phase III YD985.002/TULIP trial comparing trastuzumab duocarmazine to physician’s choice treatment in patients with pre-treated HER2-positive locally advanced or metastatic breast cancer terminated enrollment ( Manich et al, 2021 ). The results presented at the ESMO 2021 provide evidence that treatment with SYD985 may represent a new therapeutic option for these patients.…”

Section: Rebooting Her2 Testing In Breast Cancermentioning

confidence: 99%

HER2 Low, Ultra-low, and Novel Complementary Biomarkers: Expanding the Spectrum of HER2 Positivity in Breast Cancer

Venetis

Crimini

Sajjadi

et al. 2022

Front. Mol. Biosci.

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HER2 status in breast cancer is assessed to select patients eligible for targeted therapy with anti-HER2 therapies. According to the American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP), the HER2 test positivity is defined by protein overexpression (score 3+) at immunohistochemistry (IHC) and/or gene amplification at in situ hybridization (ISH). The introduction of novel anti-HER2 compounds, however, is changing this paradigm because some breast cancers with lower levels of protein expression (i.e. score 1+/2+ with no gene amplification) benefited from HER2 antibody-drug conjugates (ADC). Recently, a potential for HER2 targeting in HER2 “ultra-low” (i.e. score 0 with incomplete and faint staining in ≤10% of tumor cells) and MutL-deficient estrogen receptor (estrogen receptor)-positive/HER2-negative breast cancers has been highlighted. All these novel findings are transforming the traditional dichotomy of HER2 status and have dramatically raised the expectations in this field. Still, a more aware HER2 status assessment coupled with the comprehensive characterization of the clinical and molecular features of these tumors is required. Here, we seek to provide an overview of the current state of HER2 targeting in breast cancers beyond the canonical HER2 positivity and to discuss the practical implications for pathologists and oncologists.

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Section: Rebooting Her2 Testing In Breast Cancermentioning

confidence: 99%

HER2 Low, Ultra-low, and Novel Complementary Biomarkers: Expanding the Spectrum of HER2 Positivity in Breast Cancer

Venetis

Crimini

Sajjadi

et al. 2022

Front. Mol. Biosci.

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“…Die Hazard Ratio betrug 0,64 (95%-KI: 0,49 – 0,84; p = 0,002) 28 . Das Gesamtüberleben zeigte eine nicht statistisch signifikante Verbesserung (HR: 0,83; 95%-KI: 0,62 – 1,09; p = 0,153) 28 .…”

Section: Weiterhin Bedeutsame Fortschritte Bei Der Behandlung Von Pat...unclassified

“…Antibody-drug conjugates on the rise ADC technology has fostered the clinical development of a number of new drugs, of which trial results are now slowly being published. One such study is the TULIP trial, which uses the ADC SYD985 and also trastuzumab-duocarmycin [28]. Duocarmycin is a DNA alkylane first isolated from streptomyces bacteria in the 1970s [29].…”

Section: Therapeutic Sequences and Their Rationalementioning

confidence: 99%

“…Randomisation was 2 : 1 for treatment with SYD985 every three weeks versus treatment of physicianʼs choice (lapatinib + capecitabine, trastuzumab + capecitabine, trastuzumab + vinorelbine, trastuzumab + eribulin). More than 85 % of patients had received prior treatment with T-DM1 and about 60 % also with pertuzumab [28].…”

Section: Therapeutic Sequences and Their Rationalementioning

confidence: 99%

“…Die Technologie der ADC hat die klinische Entwicklung einer Reihe von neuen Medikamenten gefördert, von denen nun nach und nach Studienergebnisse publiziert werden. Eine dieser Studien ist die TULIP-Studie, die den ADC SYD985, oder auch Trastuzumab-Duocarmycin, nutzt [28]. Duocarmycin ist ein DNA-Alkylans, welches in den 1970er-Jahren zuerst von Streptomyces-Bakterien isoliert wurde [29].…”

Section: Antikörper-medikament-konjugate Auf Dem Vormarschunclassified

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Update Breast Cancer 2021 Part 5 – Advanced Breast Cancer

Lüftner

Schütz

Stickeler

et al. 2022

Geburtshilfe Frauenheilkd

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Despite the COVID 19 pandemic and mostly virtual congresses, innovation in the treatment of breast cancer patients continues at an unabated pace. This review summarises the current developments. Initial overall survival data for CDK4/6 inhibitor treatment in combination with an aromatase inhibitor as the first advanced line of therapy in treatment-naive postmenopausal patients have been published. Similarly, a trial comparing trastuzumab-deruxtecan versus trastuzumab-emtansine revealed a clear benefit regarding progression-free survival. Understanding of biomarkers making checkpoint inhibitor therapy particularly effective is increasing, and new compounds such as oral selective estrogen receptor destabilisers (SERDs) are entering clinical development and completing the first phase III trials.

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