58O Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment

Marmé, Frederik; Hanusch, Claus; Furlanetto, Jenny; Morris, Patrick G.; Link, T.; Denkert, C.; Fasching, Peter A.; Jackisch, Christian; Antolín, Silvia; Solbach, Christine; Aftimos, Philippe; Huober, Jens; Untch, M.; Balic, Marija; Reinisch, Mattea; Blohmer, JU; Gonçalves, Ana Sofia; Rey, Julia; Büchele, T.; Loibl, Sibylle

doi:10.1016/j.annonc.2022.03.074

Cited by 20 publications

(10 citation statements)

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“…The ongoing phase III SASCIA trial (NCT04595565) is randomizing patients with HER2-negative BC at high risk of relapse after neoadjuvant therapy to SG or TPC (capecitabine, platinum, observation). Results from the safety interim analysis showed a higher incidence of AEs and dose delays than the control arm, in line with the known safety profile of SG, although the majority were manageable using supportive measures 21 …”

Section: Sacituzumab Govitecansupporting

confidence: 62%

“…Results from the safety interim analysis showed a higher incidence of AEs and dose delays than the control arm, in line with the known safety profile of SG, although the majority were manageable using supportive measures. 21 To further expand the benefit obtained with SG, as well as with other ADCs, combination strategies are being evaluated. The combination of poly(ADP-ribose) polymerase inhibitors and ADCs with a TOP1-targeting payload is attractive because both drug classes affect the DNA damage repair pathway.…”

Section: Sacituzumab Govitecanmentioning

confidence: 99%

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Antibody-Drug Conjugates in Breast Cancer: What Is Beyond HER2?

et al. 2022

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The therapeutic landscape of patients with breast cancer has changed significantly with the introduction of antibody-drug conjugates (ADCs). Although human epidermal growth factor receptor 2 (HER2) has been the centerpiece of ADC development, potentially any surface antigen with differential expression between tumor and normal cells may be suitable for targeting with ADCs. Exploration of new targets is critical to expand the fraction of patients who can benefit from ADCs. Sacituzumab govitecan, an anti–trophoblast cell surface antigen 2 ADC, is the only non–anti-HER2 ADC approved for breast cancer to date, with several novel ADCs directed against novel targets (e.g., HER3, LIV-1) at various stages of preclinical and clinical development. The aim of this review is to provide an overview of clinical trials investigating ADCs targeting novel antigens. We discuss the optimal characteristics of the target to be exploited in ADCs' design and potential future challenges in the evolving field of ADCs such as biomarker assessment, patient selection, and sequencing of ADCs.

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Section: Sacituzumab Govitecansupporting

confidence: 62%

Section: Sacituzumab Govitecanmentioning

confidence: 99%

Antibody-Drug Conjugates in Breast Cancer: What Is Beyond HER2?

et al. 2022

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“…In early stage disease TNBC, the modest pCR rates with 12 weeks of SG as neoadjuvant treatment suggest that the optimal duration of therapy needs to be evaluated and combination therapies must be explored to improve outcomes. Single agent SG is under evaluation in patients with residual disease after neoadjuvant chemotherapy for HER2-BC (SASCIA) and early safety analyses noted that patients treated with SG reported higher frequency and higher-grade AEs compared to those treated with capecitabine on the control arm [70]. This does underscore the need to adhere to guidelines for supportive care therapies, especially in the curative setting.…”

Section: Discussionmentioning

confidence: 99%

Antibody-drug conjugates targeting TROP-2: Clinical development in metastatic breast cancer

Shastry¹,

Jacob²,

Rugo³

et al. 2022

The Breast

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“…SASCIA (NCT04595565) is a phase 3 trial that has randomized patients with TNBC or ER/PR+ breast cancer and residual disease after primary therapy to receive SG for eight cycles or TPC (capecitabine or platinum-based chemotherapy). The trial's interim safety analysis showed a higher rate of all-grade TEAEs and dose delays with SG but similar rates of dose reductions in both arms [33]. NeoSTAR was a phase II response-guided neoadjuvant trial of SG in localized TNBC with an endpoint of pCR in breast and lymph nodes (ypT0/isN0) in which patients received four cycles of SC, and patients with biopsy-proven residual disease had the option of additional neoadjuvant therapy.…”

Section: Advancing Adjuvant/neoadjuvant Treatmentmentioning

confidence: 99%

Sequencing Antibody Drug Conjugates in Breast Cancer: Exploring Future Roles

Fenton,

Tarantino,

Graff

2023

Current Oncology

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Antibody drug conjugates (ADCs) have emerged as a highly effective treatment strategy across breast cancer (BC) subtypes, including human epidermal growth factor receptor 2-positive (HER2+), hormone-receptor positive (ER/PR+), and triple-negative breast cancer (TNBC). Over the past twenty years, ADCs have undergone relevant evolutions, from target diversity to payload ratio, to linker design, allowing for a progressive increase in their efficacy. From the first-generation ADC, trastuzumab emtansine (T-DM1), approved in 2013 for HER2+ breast cancer, to next generation ADCs such as sacituzumab govitecan and trastuzumab deruxtecan, to emerging ADCs on the horizon, we continue to see unparalleled efficacy compared to traditional chemotherapy. However, each ADC has brought a new cadre of adverse events for clinicians and patients to manage. Importantly, with the development and approval of several ADCs to treat metastatic breast cancer, there are unanswered clinical questions surrounding how to optimally sequence treatment for patients who may be candidates for more than one ADC and, in general, how to treat patients beyond progression on ADCs. From bench to bedside, in this review, we will discuss the pharmacology and current indications for the novel ADCs trastuzumab deruxtecan and sacituzumab govitecan. Highlighting emerging ADCs and ongoing clinical trials, we will anticipate the changes in the breast cancer treatment paradigm. Lastly, we will outline the available data and current approaches for adverse event management and sequencing strategies for ADCs in clinical practice, including proposed mechanisms of resistance.

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58O Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment

Cited by 20 publications

References 0 publications

Antibody-Drug Conjugates in Breast Cancer: What Is Beyond HER2?

Antibody-Drug Conjugates in Breast Cancer: What Is Beyond HER2?

Antibody-drug conjugates targeting TROP-2: Clinical development in metastatic breast cancer

Sequencing Antibody Drug Conjugates in Breast Cancer: Exploring Future Roles

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