Startseite Kongressberichte & Archiv 2021 ASCO Annual Meeting Breast Cancer Breast Cancer—Metastatic
Prospective longitudinal multi-omics study of palbociclib resistance in hormone receptor+/HER2- metastatic breast cancer.
Yeon Hee Park, Seock-Ah Im, Kyunghee Park, et al.
The study authors conclude that their study identified prognostic biomarkers as well as post-treatment enrichment of homologous recombination deficiency-related genomic scars and frequent switching into molecular subtypes with aggressive and estrogen independence characteristics. Clinical trial information: NCT03401359.
CCNE1 mRNA and cyclin E1 protein expression as predictive biomarkers for efficacy of palbociclib plus fulvestrant versus capecitabine in the phase III PEARL study.
Javier Pascual, Miguel Gil-Gil, Christoph Zielinski, et al.
The study authors conclude that high tumor CCNE1 mRNA expression identified patients with relative resistance to palbociclib plus fulvestrant. This validates prior observations but without statistical significance for interaction. Assessment of Cyclin E1 protein expression did not show predictive value. Clinical trial information: NCT02028507.
Characterizing demographics, clinical, and genomic characteristics for U.S. patients with HR+, HER2- metastatic breast cancer following progression on a CDK4 and 6 inhibitor.
Fabrice Andre, Amit Aggarwal, Xi Rao, et al.
The study authors conclude that their findings describe clinical characteristics and specific genomic alterations noted after progression on CDK4 & 6i +/-endocrine therapy.
Predictors of non-receipt of first-line CDK 4/6 inhibitors (CDK4/6i) among patients with metastatic breast cancer (MBC).
Kimberley T Lee, Elaine Chiao, David Lim, et al.
The study authors identified disparities in the use of CDK4/6i for the first-line treatment of metastatic breast cancer. The observed lower use among patients who received care at the urban Baltimore city site with a trend towards lower use among patients from lower-income neighborhoods. This highlights potential barriers with accessing oral cancer therapies - cost, patient distrust, and/or systemic bias.
Safety and activity of single-agent giredestrant (GDC-9545) from a phase Ia/b study in patients (pts) with estrogen receptor-positive (ER+), HER2-negative locally advanced/metastatic breast cancer (LA/mBC).
Komal L. Jhaveri, Valentina Boni, Joohyuk Sohn, et al.
The study authors conclude that Single-agent giredestrant - a highly potent, nonsteroidal oral selective ER degrader - was well tolerated at all doses. There were no dose-limiting toxicities observed and adverse events were generally low grade and in keeping with expected adverse events for endocrine therapies. Clinical activity was observed at all doses. Clinical trial information: NCT03332797.
Phase I/II study of H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Erika P. Hamilton, Judy S. Wang, Timothy J. Pluard, et al.
The study authors conclude that the selective, small molecule covalent antagonist of ERα H3B-6545 has a manageable safety profile and demonstrated single-agent anti-tumor activity in heavily pretreated ER+, HER2- mBC patients. Clinical activity was observed in patients with ESR1 mutations. Clinical trial information: NCT03250676.
A phase Ib study of proxalutamide (GT0918) in women with androgen receptor-positive metastatic breast cancer.
Huiping Li, Hanfang Jiang, Yongmei Yin, et al.
GT0918 is a new chemical entity of AR antagonist with possible AR down-regulation. The study authors conclude that this drug has been shown to be well tolerated and may provide potential clinical benefits to androgen receptor-positive metastatic breast cancer patients. This study demonstrated triple-negative androgen receptor-positive patients had more benefit. Clinical trial information: NCT04103853.
Efficacy of enobosarm, a selective androgen receptor (AR) targeting agent, correlates with the degree of AR positivity in advanced AR+/estrogen receptor (ER)+ breast cancer in an international phase 2 clinical study.
Carlo Palmieri, Hannah M. Linden, Stephen Birrell, et al.
Enobosarm is a novel oral selective androgen receptor (AR) activating agent in which a higher percentage of AR staining correlates with a greater antitumor activity. The study authors conclude that by targeting and activating AR, enobosarm may represent a new hormone treatment approach for AR+/ER+ MBC. Clinical trial information: NCT02463032.
Marietta Scott, Michel Erminio Vandenberghe, Paul Scorer, et al.
The study authors show that HER2 IHC1+/2+ (ISH-) by Ventana 4B5 represent a significant proportion of breast cancer patients and more than 50% of ER+ve and PR+ve subtypes. The study demonstrated that the 4B5 assay classed several patients as IHC1+/2+ that are IHC0 by Herceptest, but almost all patients IHC0 by 4B5 were also IHC0 by Herceptest.
RC48-ADC, a HER2-targeting antibody-drug conjugate, in patients with HER2-positive and HER2-low expressing advanced or metastatic breast cancer: A pooled analysis of two studies.
Jiayu Wang, Yunjiang Liu, Qingyuan Zhang, et al.
The study authors conclude that RC48-ADC showed consistent efficacy in HER2-positive and HER2-low expressing subgroups. It was demonstrated, that the 2.0 mg/kg Q2W showed a more favorable benefit-risk ratio than other dose levels. No new safety signals were observed. Clinical trial information: NCT02881138; NCT03052634.
BEGONIA: Phase 1b/2 study of durvalumab (D) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC)—Initial results from arm 1, d+paclitaxel (P), and arm 6, d+trastuzumab deruxtecan (T-DXd).
Peter Schmid, Seock-Ah Im, Anne Armstrong, et al.
The study authors conclude that durvalumab + paclitaxel demonstrated a tolerable safety profile and response rate as expected for a 1st-line triple-negative breast cancer IO/taxane combination. Durvalumab + trastuzumab deruxtecan showed promising early safety and efficacy in 1st-line HER2-low–expressing triple-negative breast cancer; Clinical trial information: NCT03742102.
Xichun Hu, Jian Zhang, Rujiao Liu, Shuiping Gao, et al.
The study authors conclude that A166 - an antibody-drug conjugate composed of a novel cytotoxic drug (Duo-5, anti-microtubule agent) - had a manageable safety profile and high stability in the circulation with much lower acute hematological and gastrointestinal toxicities in terms of incidence rate and grade. The drug demonstrated promising antitumor activity with clinically meaningful responses in heavily pretreated subjects with HER2-positive breast cancer. Clinical trial information: CTR20181301.