HER2 Breast Cancer

The Independent Data Monitoring Committee concluded that DESTINY-Breast03 met the primary endpoint of progression-free survival and showed a highly statistically significant and clinically meaningful improvement for patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

Ribociclib was found to prolong overall survival and improve post-progression outcomes in patients with HR-positive/HER2−negative advanced breast cancer, particularly among younger patients with a significant unmet need.

The trial, in phase 3, is the first to report data comparing a neoadjuvant anti-HER2 based regimen with or without the anti-PD-L1 antibody, atezolimumab, in patients with high-risk, HER2-positive early breast cancer.

Margetuximab, trastuzumab deruxtecan, and tucatinib have all been approved in the past 2 years for the treatment of various subsets of patients with breast cancer.

Breast cancer patients with low or absent MLH1 or PMS2 gene expression may have even greater risks of death.

Data presented at the 2021 ESMO Breast Cancer Virtual Congress showed 29% of recurrent breast cancer biopsies showed conversion either from, or to, HER2-low expression.

Over the past 18 months, the FDA has approved 4 new regimens for HER2-positive metastatic disease.

A session at the Community Oncology Alliance virtual 2021 conference noted that clinical trials have found promising new treatments for patients with breast cancer, offering opportunities for future new approvals and indications.

A review of the efficacy of HER2-positive–targeted agents for metastatic breast cancer.

A 5% weight loss over 2 years in patients with HER2-positive early breast cancer was associated with worse outcomes, according to new research that investigated the BMI data of these patients.

The FDA has granted a fast track designation to an investigational antibody-drug conjugate for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer.

Symposium speakers discussed how CDK4/6 inhibitors are game changers in treatment of HR+/HER2- advanced breast cancer.

FDA approves margetuximab-cmkb (Margenza) in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have previously received 2 or more anti-HER2 regimens.

Tesetaxel is a novel, oral taxane with several unique properties being investigated for use in patients with HER2-negative, HR-positive metastatic breast cancer.

ET and CT are used as standard maintenance therapy for HR-positive and HER-negative MBC in clinical practice, and there was no prospective study data on which is better, according to the study authors.

Adding abemaciclib to hormonal therapy reduces the risk of cancer recurrence by 25% in patients with high-risk early hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer.

Understanding the role of abemaciclib (Verzenio) in managing patients with hormone receptor positive and human epidermal growth factor receptor 2 negative metastatic breast cancer is crucial.

Following initial breast cancer diagnosis by mammography, MRI, or ultrasound, treatment is largely based upon the histologic subtype and staging of the tumor(s).

The most common adverse reactions observed in the monarchE phase 3 trial include diarrhea, neutropenia, fatigue, infections, nausea, abdominal pain, vomiting, anemia, alopecia, decreased appetite, and leukopenia.

Trastuzumab deruxtecan (T-DXd) (Enhertu) demonstrated strong efficacy in a phase 2 trial for treatment of HER2-positive metastatic breast cancer.

The objective of the study was to develop an education program that increased confidence and knowledge of pharmacists managing CDK4/6 inhibitors.

This approval is a part of the first Project Orbis partnership between the FDA, Health Sciences Authority, and Swissmedic.

Trastuzumab-dttb was first approved in January 2019 across all eligible indications, mainly adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer.

Officials from the FDA have approved a supplemental New Drug Application (sNDA) for neratinib (NERLYNX, Puma Biotechnology) in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer that have received 2 or more prior anti-HER2-based regimens in the metastatic setting.

HER2 is a membrane-bound tyrosine kinase that when amplified contributes significantly to a tumor’s ability to proliferate and survive.

A combination therapy may counter the resistance to human epidermal growth factor receptor 2 inhibitor neratinib in patients with breast, ovarian, lung, or other cancers.

Margetuximab plus chemotherapy showed positive results in a second pre-specified interim overall survival analysis for the phase 3 SOPHIA study.

By entering clinical and disease characteristics into a learning algorithm, researchers were able to create an efficacy prediction for CDK inhibitors.

Abemaciclib is a potent oral cyclin-dependent kinase 4/6 inhibitor that has previously demonstrated statistically significant improvement in PFS and ORR in combination with endocrine therapy.

Officials with the FDA have granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi-Sankyo) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer that have received 2 or more prior anti-HER2-based regimens in the metastatic setting.