
HER2+ Breast Cancer
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The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers.
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The novel HER2-targeted bispecific antibody zanidatamab in combination with docetaxel demonstrated efficacy with a manageable safety profile as first-line treatment in patients with advanced HER2-positive breast cancer.

Treatment with the all-oral triplet of tucatinib, letrozole, and palbociclib yielded clinically meaningful efficacy results and had an acceptable safety profile in patients with hormone receptor–positive, HER2-positive metastatic breast cancer.

The combination of tucatinib and ado-trastuzumab emtansine elicited an improvement in progression-free survival compared with placebo plus T-DM1 in patients with HER2-positive metastatic breast cancer who received previous treatment with a taxane and trastuzumab in any setting.

Nancy U. Lin, MD, discusses selecting between systemic vs local therapy for patients with HER2-positive breast cancer displaying central nervous system metastases.

Erika P. Hamilton, MD, discusses the role of trastuzumab deruxtecan in HER2-positive and HER2-low breast cancer; the evolution of CDK4/6 inhibitors in hormone receptor–positive disease; and how genetic testing can match patients with personalized therapies and support further precision medicine research.

Nicole O Williams, MD, discusses unmet needs for patients with HER2-positive breast cancer and potential future research directions in the space.

Ian E. Krop, MD, PhD, discusses the use of fam-trastuzumab deruxtecan-nxki across age groups in the DESTINY Breast trials in patients with HER2-positive metastatic breast cancer.

Adrienne G. Waks, MD, spotlights the need to understand mechanisms of resistance to second-line HER2-positive breast cancer therapies, chemotherapy-free regimens with later-line treatment potential, and the future of HER2-positive disease management.

Adrienne G. Waks, MD, spotlights the role of the HER2CLIMB regimen in patients with HER2-positive breast cancer with brain metastases, discusses unmet needs in the fourth- and later-line settings in HER2-positive disease, and explains the basis for the ongoing HER2CLIMB-02 and HER2CLIMB-04 trials within the broader ADC landscape.

Kai Conrad Cecil Johnson, MD, discusses key invasive disease-free survival findings from the final 10-year analysis of the phase 2 APT trial and HER2DX exploratory analyses in patients with HER2-positive breast cancer.

China’s National Medical Products Administration has approved trastuzumab deruxtecan monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer who have previously received a systemic therapy in the metastatic setting or whose disease recurred during or within 6 months of adjuvant chemotherapy.

A treatment regimen consisting of pepinemab plus trastuzumab and a dendritic cell vaccine, followed by autologous CD4-positive T cells, is under investigation in a phase 1 trial in patients with metastatic HER2-positive breast cancer.

Neoadjuvant zanidatamab monotherapy successfully reduced the incidence of residual disease and was well tolerated in treatment-naïve women with node negative, stage I HER2-positive breast cancer, potentially allowing patients to achieve pathologic complete responses in the absence of chemotherapy.

Bob T. Li, MD, PhD, MPH, discusses the results of a phase 1/2 study of the first-in-class immune-stimulating antibody conjugate BDC-1001 in patients with advanced HER2-expressing solid tumors.

Funda Meric-Bernstam, MD, discusses the phase 2 DESTINY-PanTumor02 trial of trastuzumab deruxtecan in difficult-to-treat HER2-positive solid tumors.

Subcutaneous delivery of fixed-dose adjuvant pertuzumab plus trastuzumab proved to have favorable tolerability, with a safety profile consistent with that seen with intravenous delivery of the regimen in patients with HER2-positive breast cancer.

Experts in the field share the abstracts they found to be the most practice changing at this year’s ASCO Annual meeting.

Atezolizumab in combination with trastuzumab and vinorelbine generated responses and a tolerable safety profile in patients with HER2-positive, estrogen receptor–negative or ER-positive/PAM50 non-luminal advanced breast cancer, according to data from a prespecified interim analysis of the phase 2 ATREZZO trial.

Christie J. Hilton, DO, discusses the potential impact of the ongoing phase 2 CompassHER2-pCR trial for patients with HER2-positive breast cancer.

Christie J. Hilton, DO, discusses the impact of trastuzumab deruxtecan on the treatment of patients with HER2-positive metastatic breast cancer and ongoing research with the agent in this patient population.

Lida A. Mina, MD, discusses the evolution of the antibody-drug conjugates fam-trastuzumab deruxtecan-nxki and ado-trastuzumab emtansine in HER2-positive breast cancer.

Lida A. Mina, MD, discusses the evolving role of ADCs across breast cancer subtypes, current data on the use of CDK4/6 inhibitors in HR-positive, HER2-negative breast cancer, and the increased use of genomic testing and NGS to improve the sequencing of agents in triple-negative breast cancer.

Nusayba Bagegni, MD, details ongoing research and possibilities for the treatment landscape in the future, which includes investigating escalating approaches through more research in clinical trials.

The FDA has issued a complete response letter to the biologics license application for vic-trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic breast cancer.

Preoperative treatment with atezolizumab, epirubicin, trastuzumab, and pertuzumab led to improved rates of pathologic complete response and decreased residual cancer burden compared with trastuzumab, pertuzumab, and chemotherapy alone in patients with early-stage HER2-positive breast cancer, according to findings from the randomized phase 2 ATHENE trial.

























































