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Article ; Online: Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study.

Modi, Shanu

2021 Volume 17, Issue 26, Page(s) 3415–3423

Abstract: This is a summary of the article discussing the results of the DESTINY-Breast01 study originally published in ... ...

Abstract	This is a summary of the article discussing the results of the DESTINY-Breast01 study originally published in the
MeSH term(s)	Adult ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Camptothecin/analogs & derivatives ; Female ; Humans ; Immunoconjugates ; Language ; Receptor, ErbB-2/genetics ; Trastuzumab/adverse effects
Chemical Substances	Immunoconjugates ; trastuzumab deruxtecan (5384HK7574) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; Camptothecin (XT3Z54Z28A)
Language	English
Publishing date	2021-07-15
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	2274956-1
ISSN	1744-8301 ; 1479-6694
ISSN (online)	1744-8301
ISSN	1479-6694
DOI	10.2217/fon-2021-0427
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Article ; Online: Management of patients with advanced-stage HER2-positive breast cancer: current evidence and future perspectives.

Marra, Antonio / Chandarlapaty, Sarat / Modi, Shanu

Nature reviews. Clinical oncology

2024 Volume 21, Issue 3, Page(s) 185–202

Abstract: Amplification and/or overexpression of ERBB2, the gene encoding HER2, can be found in 15-20% of invasive breast cancers and is associated with an aggressive phenotype and poor clinical outcomes. Relentless research efforts in molecular biology and drug ... ...

Abstract	Amplification and/or overexpression of ERBB2, the gene encoding HER2, can be found in 15-20% of invasive breast cancers and is associated with an aggressive phenotype and poor clinical outcomes. Relentless research efforts in molecular biology and drug development have led to the implementation of several HER2-targeted therapies, including monoclonal antibodies, tyrosine-kinase inhibitors and antibody-drug conjugates, constituting one of the best examples of bench-to-bedside translation in oncology. Each individual drug class has improved patient outcomes and, importantly, the combinatorial and sequential use of different HER2-targeted therapies has increased cure rates in the early stage disease setting and substantially prolonged survival for patients with advanced-stage disease. In this Review, we describe key steps in the development of the modern paradigm for the treatment of HER2-positive advanced-stage breast cancer, including selecting and sequencing new-generation HER2-targeted therapies, and summarize efficacy and safety outcomes from pivotal studies. We then outline the factors that are currently known to be related to resistance to HER2-targeted therapies, such as HER2 intratumoural heterogeneity, activation of alternative signalling pathways and immune escape mechanisms, as well as potential strategies that might be used in the future to overcome this resistance and further improve patient outcomes.
MeSH term(s)	Humans ; Female ; Antineoplastic Agents/therapeutic use ; Antineoplastic Agents/pharmacology ; Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Receptor, ErbB-2/metabolism ; Antibodies, Monoclonal/therapeutic use ; Signal Transduction
Chemical Substances	Antineoplastic Agents ; Receptor, ErbB-2 (EC 2.7.10.1) ; Antibodies, Monoclonal
Language	English
Publishing date	2024-01-08
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2491410-1
ISSN	1759-4782 ; 1759-4774
ISSN (online)	1759-4782
ISSN	1759-4774
DOI	10.1038/s41571-023-00849-9
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Zs.A 6029: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Trastuzumab Deruxtecan in HER2-Low Breast Cancer. Reply.

Modi, Shanu / Gambhire, Dhiraj / Cameron, David

The New England journal of medicine

2022 Volume 387, Issue 12, Page(s) 1145–1146

MeSH term(s)	Breast Neoplasms/drug therapy ; Camptothecin/analogs & derivatives ; Female ; Humans ; Immunoconjugates ; Trastuzumab/therapeutic use
Chemical Substances	Immunoconjugates ; trastuzumab deruxtecan (5384HK7574) ; Trastuzumab (P188ANX8CK) ; Camptothecin (XT3Z54Z28A)
Language	English
Publishing date	2022-09-21
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2210368
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Article ; Online: Beyond HER2: Targeting the ErbB receptor family in breast cancer.

Drago, Joshua Z / Ferraro, Emanuela / Abuhadra, Nour / Modi, Shanu

Cancer treatment reviews

2022 Volume 109, Page(s) 102436

Abstract: Targeting the HER2 oncogene represents one of the greatest advances in the treatment of breast cancer. HER2 is one member of the ERBB-receptor family, which includes EGFR (HER1), HER3 and HER4. In the presence or absence of underling genomic aberrations ... ...

Abstract	Targeting the HER2 oncogene represents one of the greatest advances in the treatment of breast cancer. HER2 is one member of the ERBB-receptor family, which includes EGFR (HER1), HER3 and HER4. In the presence or absence of underling genomic aberrations such as mutations or amplification events, intricate interactions between these proteins on the cell membrane lead to downstream signaling that encourages cancer growth and proliferation. In this Review, we contextualize efforts to pharmacologically target the ErbB receptor family beyond HER2, with a focus on EGFR and HER3. Preclinical and clinical efforts are synthesized. We discuss successes and failures of this approach to date, summarize lessons learned, and propose a way forward that invokes new therapeutic modalities such as antibody drug conjugates (ADCs), combination strategies, and patient selection through rational biomarkers.
MeSH term(s)	Breast Neoplasms/drug therapy ; Breast Neoplasms/genetics ; Breast Neoplasms/metabolism ; Female ; Humans ; Receptor, ErbB-2/metabolism ; Receptor, ErbB-3/genetics ; Receptor, ErbB-3/metabolism ; Signal Transduction
Chemical Substances	Receptor, ErbB-2 (EC 2.7.10.1) ; Receptor, ErbB-3 (EC 2.7.10.1)
Language	English
Publishing date	2022-07-15
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	125102-8
ISSN	1532-1967 ; 0305-7372
ISSN (online)	1532-1967
ISSN	0305-7372
DOI	10.1016/j.ctrv.2022.102436
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Zs.A 1022: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions.

Ferraro, Emanuela / Drago, Joshua Z / Modi, Shanu

Breast cancer research : BCR

2021 Volume 23, Issue 1, Page(s) 84

Abstract: The development of anti-HER2 agents has been one of the most meaningful advancements in the management of metastatic breast cancer, significantly improving survival outcomes. Despite the efficacy of anti-HER2 monoclonal antibodies, concurrent ... ...

Abstract	The development of anti-HER2 agents has been one of the most meaningful advancements in the management of metastatic breast cancer, significantly improving survival outcomes. Despite the efficacy of anti-HER2 monoclonal antibodies, concurrent chemotherapy is still needed to maximize response. Antibody-drug conjugates (ADCs) are a class of therapeutics that combines an antigen-specific antibody backbone with a potent cytotoxic payload, resulting in an improved therapeutic index. Two anti-HER2 ADCs have been approved by the FDA with different indications in HER2-positive breast cancer. Ado-trastuzumab emtansine (T-DM1) was the first-in-class HER2-targeting ADC, initially approved in 2013 for metastatic patients who previously received trastuzumab and a taxane, and the label was expanded in 2019 to include adjuvant treatment of high-risk patients with residual disease after neoadjuvant taxane and trastuzumab-based therapy. In 2020, trastuzumab deruxtecan (T-DXd) was the second approved ADC for patients who had received at least 2 lines of anti-HER2-based therapy in the metastatic setting. The success of these two agents has transformed the treatment of HER2-positive breast cancer and has re-energized the field of ADC development. Given their advanced pharmaceutical properties, next-generation HER2-targeted ADCs have the potential to be active beyond traditional HER2-positive breast cancer and may be effective in cells with low expression of HER2 or ERBB2 mutations, opening a spectrum of new possible clinical applications. Ongoing challenges include improving target-specificity, optimizing the toxicity profile, and identifying biomarkers for patient selection. The aim of this review is to summarize the principal molecular, clinical, and safety characteristics of approved and experimental anti-HER2 ADCs, contextualizing the current and future landscape of drug development.
MeSH term(s)	Antineoplastic Agents/adverse effects ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Breast Neoplasms/drug therapy ; Breast Neoplasms/metabolism ; Breast Neoplasms/pathology ; Central Nervous System Neoplasms/drug therapy ; Central Nervous System Neoplasms/secondary ; Drug Development/trends ; Drug-Related Side Effects and Adverse Reactions ; Female ; Humans ; Immunoconjugates/adverse effects ; Immunoconjugates/pharmacology ; Immunoconjugates/therapeutic use ; Receptor, ErbB-2/antagonists & inhibitors ; Receptor, ErbB-2/metabolism
Chemical Substances	Antineoplastic Agents ; Immunoconjugates ; ERBB2 protein, human (EC 2.7.10.1) ; Receptor, ErbB-2 (EC 2.7.10.1)
Language	English
Publishing date	2021-08-11
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2015059-3
ISSN	1465-542X ; 1465-5411
ISSN (online)	1465-542X
ISSN	1465-5411
DOI	10.1186/s13058-021-01459-y
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Zs.A 5494: Show issues

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Article ; Online: Unlocking the potential of antibody-drug conjugates for cancer therapy.

Drago, Joshua Z / Modi, Shanu / Chandarlapaty, Sarat

Nature reviews. Clinical oncology

2021 Volume 18, Issue 6, Page(s) 327–344

Abstract: Nine different antibody-drug conjugates (ADCs) are currently approved as cancer treatments, with dozens more in preclinical and clinical development. The primary goal of ADCs is to improve the therapeutic index of antineoplastic agents by restricting ... ...

Abstract	Nine different antibody-drug conjugates (ADCs) are currently approved as cancer treatments, with dozens more in preclinical and clinical development. The primary goal of ADCs is to improve the therapeutic index of antineoplastic agents by restricting their systemic delivery to cells that express the target antigen of interest. Advances in synthetic biochemistry have ushered in a new generation of ADCs, which promise to improve upon the tissue specificity and cytotoxicity of their predecessors. Many of these drugs have impressive activity against treatment-refractory cancers, although hurdles impeding their broader use remain, including systemic toxicity, inadequate biomarkers for patient selection, acquired resistance and unknown benefit in combination with other cancer therapies. Emerging evidence indicates that the efficacy of a given ADC depends on the intricacies of how the antibody, linker and payload components interact with the tumour and its microenvironment, all of which have important clinical implications. In this Review, we discuss the current state of knowledge regarding the design, mechanism of action and clinical efficacy of ADCs as well as the apparent limitations of this treatment class. We then propose a path forward by highlighting several hypotheses and novel strategies to maximize the potential benefit that ADCs can provide to patients with cancer.
MeSH term(s)	Animals ; Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Agents, Immunological/chemistry ; Antineoplastic Agents, Immunological/pharmacology ; Antineoplastic Agents, Immunological/therapeutic use ; Drug Resistance, Neoplasm/drug effects ; Drug Resistance, Neoplasm/physiology ; Humans ; Immunoconjugates/adverse effects ; Immunoconjugates/chemistry ; Immunoconjugates/pharmacology ; Immunoconjugates/therapeutic use ; Neoplasms/drug therapy ; Patient Selection
Chemical Substances	Antineoplastic Agents, Immunological ; Immunoconjugates
Language	English
Publishing date	2021-02-08
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2491410-1
ISSN	1759-4782 ; 1759-4774
ISSN (online)	1759-4782
ISSN	1759-4774
DOI	10.1038/s41571-021-00470-8
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Article ; Online: Multifocal and pathologically-confirmed brain metastasis complete response to trastuzumab deruxtecan.

Moss, Nelson S / Tosi, Umberto / Santomasso, Bianca D / Beal, Kathryn / Modi, Shanu

CNS oncology

2022 Volume 11, Issue 3, Page(s) CNS90

Abstract: Antibody-drug conjugates have transformed the treatment of HER2+ breast and other cancers. Unfortunately, the CNS remains a sanctuary site for many such patients in part due to poor macromolecule penetration across the blood-brain tumor barrier. ... ...

Abstract	Antibody-drug conjugates have transformed the treatment of HER2+ breast and other cancers. Unfortunately, the CNS remains a sanctuary site for many such patients in part due to poor macromolecule penetration across the blood-brain tumor barrier. Trastuzumab deruxtecan (T-DXd), a high-payload antibody-drug conjugate, was recently found to improve progression-free survival in HER2+ breast cancer patients versus prior-generation trastuzumab emtansine, prompting us to evaluate CNS activity in a woman with brain-only metastatic disease. T-DXd achieved complete response despite heavy pretreatment. Three persistent, previously-irradiated lesions were biopsy-proven to represent treatment effect. Subsequent recurrence occurred upon treatment holiday; partial response was observed with rechallenge. This case suggests T-DXd is active in HER2+ breast cancer brain metastases and supports further prospective evaluation.
MeSH term(s)	Antibodies, Monoclonal, Humanized/therapeutic use ; Brain Neoplasms/diagnostic imaging ; Brain Neoplasms/drug therapy ; Breast Neoplasms/diagnostic imaging ; Breast Neoplasms/drug therapy ; Camptothecin/analogs & derivatives ; Female ; Humans ; Immunoconjugates/therapeutic use ; Receptor, ErbB-2/therapeutic use ; Trastuzumab
Chemical Substances	Antibodies, Monoclonal, Humanized ; Immunoconjugates ; trastuzumab deruxtecan (5384HK7574) ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; Camptothecin (XT3Z54Z28A)
Language	English
Publishing date	2022-06-08
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2692808-5
ISSN	2045-0915 ; 2045-0915
ISSN (online)	2045-0915
ISSN	2045-0915
DOI	10.2217/cns-2022-0010
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Article: Targeting HER2-low in metastatic breast cancer: an evolving treatment paradigm.

Yang, Charlie / Brezden-Masley, Christine / Joy, Anil Abraham / Sehdev, Sandeep / Modi, Shanu / Simmons, Christine / Henning, Jan-Willem

Therapeutic advances in medical oncology

2023 Volume 15, Page(s) 17588359231175440

Abstract: The results of the Phase III DESTINY-Breast04 trial of trastuzumab deruxtecan (T-DXd) are leading to a shift in both the classification and treatment of human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. In this trial, T- ... ...

Abstract	The results of the Phase III DESTINY-Breast04 trial of trastuzumab deruxtecan (T-DXd) are leading to a shift in both the classification and treatment of human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. In this trial, T-DXd was associated with a substantial survival benefit among patients with hormone receptor-positive and hormone receptor-negative disease and low expression of HER2, a biomarker previously considered unactionable in this treatment setting. Herein, we discuss the evolving therapeutic pathway for HER2-low disease, ongoing clinical trials, and the potential challenges and evidence gaps arising with treatment of this patient population.
Language	English
Publishing date	2023-06-05
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2503443-1
ISSN	1758-8359 ; 1758-8340
ISSN (online)	1758-8359
ISSN	1758-8340
DOI	10.1177/17588359231175440
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Article: Incidence of HER2-expressing brain metastases in patients with HER2-null breast cancer: a matched case analysis.

Moss, Nelson S / Singh, Jolene M / Reiner, Anne S / Drago, Joshua Z / Modi, Shanu / Seidman, Andrew D / Chandarlapaty, Sarat / Ross, Dara S

NPJ breast cancer

2023 Volume 9, Issue 1, Page(s) 86

Abstract: The HER2-directed antibody-drug conjugate trastuzumab deruxtecan is active against lower levels of HER2 expression than prior-generation therapies. The rate of HER2 expression in brain metastases among patients with initially HER2-null breast cancer is ... ...

Abstract	The HER2-directed antibody-drug conjugate trastuzumab deruxtecan is active against lower levels of HER2 expression than prior-generation therapies. The rate of HER2 expression in brain metastases among patients with initially HER2-null breast cancer is undefined, and receptor discordance in advanced breast cancer with brain metastases may underestimate CNS response potential in the absence of brain metastasis sampling. In this cohort study including 136 patients with 401 samples scored according to ASCO/CAP guidelines, 15/28 patients (54%) with HER2-null primary breast cancer have detectable HER2 expression in subsequently resected brain metastases, a significant discordant population.
Language	English
Publishing date	2023-10-23
Publishing country	United States
Document type	Journal Article
ISSN	2374-4677
ISSN	2374-4677
DOI	10.1038/s41523-023-00592-5
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Article ; Online: Trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2-expressing salivary gland carcinoma: a pooled analysis of two phase I studies.

Takahashi, Shunji / Bando, Hideaki / Kinoshita, Ichiro / Modi, Shanu / Tsurutani, Junji / Bang, Yung-Jue / Sato, Yuta / Nakatani, Shunsuke / Lee, Caleb / Sugihara, Masahiro / Okuda, Yasuyuki / Iwata, Hiroji

Japanese journal of clinical oncology

2024 Volume 54, Issue 4, Page(s) 434–443

Abstract: Background: HER2-expressing salivary gland carcinoma (SGC) is associated with poor prognosis. Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies. This study aimed ...

Abstract	Background: HER2-expressing salivary gland carcinoma (SGC) is associated with poor prognosis. Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies. This study aimed to present the efficacy and safety of T-DXd in patients with HER2-expressing SGC from a pooled analysis. Methods: Patients with HER2-expressing SGC were pooled from two phase I, open-label studies of T-DXd: a two-phase, multiple-dose, first-in-human study (NCT02564900) and a single-sequence crossover drug-drug interaction study (NCT03383692). Endpoints included efficacy (objective response rate [ORR], duration of response [DoR] and progression-free survival [PFS]) and safety. Results: This pooled analysis included 17 patients with SGC (median age: 57 years; male: 88.2%); median (range) follow-up duration was 12.0 (2.3-‍34.8) months. Among these patients, 14 had received prior HER2-targeted agents and 13 had undergone prior radiotherapy. The investigator-assessed confirmed ORR was 58.8% (95% confidence interval [CI], 32.9-‍81.6). The median (95% CI) DoR and PFS were 17.6 months (4.0 to not evaluable [NE]) and 20.5 months (11.1-NE), respectively. All 17 patients reported treatment-emergent adverse events (TEAEs); 76.5% reported TEAEs of grade ≥3. The most common TEAEs were decreased appetite (94.1%), nausea (88.2%) and neutrophil count decreased (76.5%). Of the 17 patients, five (29.4%) reported adjudicated drug-related interstitial lung disease (grade 1, n = 3; grade 2, n =1; grade 3, n = 1). Conclusion: The results of this pooled analysis provide evidence that clinical benefit is achievable with T-DXd in patients with HER2-expressing SGC. Clinical trial information: FIH study, NCT02564900; DDI study, NCT03383692.
MeSH term(s)	Humans ; Male ; Middle Aged ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Camptothecin/therapeutic use ; Camptothecin/analogs & derivatives ; Carcinoma/drug therapy ; Immunoconjugates/adverse effects ; Immunoconjugates/therapeutic use ; Receptor, ErbB-2/metabolism ; Salivary Glands/metabolism ; Trastuzumab/adverse effects ; Trastuzumab/therapeutic use ; Female
Chemical Substances	Antibodies, Monoclonal, Humanized ; Camptothecin (XT3Z54Z28A) ; ERBB2 protein, human (EC 2.7.10.1) ; Immunoconjugates ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; trastuzumab deruxtecan (5384HK7574)
Language	English
Publishing date	2024-01-17
Publishing country	England
Document type	Meta-Analysis ; Journal Article
ZDB-ID	190978-2
ISSN	1465-3621 ; 0368-2811
ISSN (online)	1465-3621
ISSN	0368-2811
DOI	10.1093/jjco/hyad181
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