HER2+ Breast Cancer

The European Commission has approved fam-trastuzumab deruxtecan-nxki for use as a single agent in adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received at least 1 anti–HER2-based regimen.

The European Medicines Agency has validated the marketing authorization application for trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable, locally advanced or metastatic breast cancer.

Neratinib-based combinations, antibody-drug conjugates, and bispecific antibodies represent novel and effective treatment options for patients with pretreated HER2-mutant and HER2-low metastatic breast cancer, but the successful integration of these regimens into care will require further investigation into current definitions of HER2 positivity.

Adrienne G. Waks, MD, highlights clinical trials that are studying emerging treatment escalation and de-escalation strategies in early stage HER2-positive breast cancer, elaborates on the future of immunotherapy in this setting, and explains the significance of establishing new biomarkers.

The addition of pertuzumab to standard adjuvant therapy of trastuzumab and chemotherapy continued to reduce the risk of disease recurrence or death for patients with HER2-positive early breast cancer according to data from the third interim overall survival analysis of the phase 3 APHINITY trial.

The FDA has accepted for review a biologics license application for vic-trastuzumab duocarmazine for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer.

Vered Stearns, MD, FASCO, discusses how DESTINY-Breast04 has shifted the treatment paradigm for patients with HER2-low breast cancer, the exploration of treatment combinations being optimized in breast cancer, and the expansion of the treatment paradigm in triple-negative breast cancer.

Gregory Vidal, MD, PhD, discusses the impact of the phase 3 KATHERINE trial in HER2-positive breast cancer.

Adding atezolizumab to neoadjuvant standard of care therapy for HER2-positive early breast cancer did not result in a better pathologic complete response compared with placebo, according to findings from the phase 3 IMpassion050 trial.

Adjuvant treatment with TX05 resulted in a similar disease-free survival benefit to that of trastuzumab in patients with early-stage HER2-positive breast cancer.

Naomi Dempsey, MD, discusses the role of de-escalation therapy in early-stage, HER2-positive breast cancer and provides highlights from ongoing clinical trials in the space.

Heather McArthur, MD, MPH, described how the data from DESTINY-Breast03 reshapes the treatment landscape and offers added benefit to patients with brain metastases.

Poziotinib prolonged overall survival in heavily pretreated Korean patients with HER2-positive metastatic breast cancer.

Advancements in treatment options across the spectrum on women’s cancers include de-escalating therapy in HER2-positive breast cancer, using tisotumab vedotin-tftv in cervical cancer, shifting therapies to the frontline setting in endometrial cancer, and using checkpoint inhibitors in ovarian cancer.

The addition of nivolumab to trastuzumab deruxtecan did not result in a marked clinical benefit in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

HER2 expression appeared to be a significant predictor for response to fam-trastuzumab deruxtecan-nxki, according to findings from a biomarker analysis of patients with metastatic breast cancer in the phase 2 DAISY trial.

Nearly all patients with HER2-positive breast cancer with brain metastases who received fam-trastuzumab deruxtecan-nxki elicited benefit, according to data from a primary outcome analysis of the phase 2 TUXEDO-1 trial.

Overall health status and quality of life were maintained among patients with HER2-positive metastatic breast cancer who were treated with fam-trastuzumab deruxtecan-nxki compared with those who received ado-trastuzumab emtansine.

Neoadjuvant therapy generated similar benefits to adjuvant therapy in patients with early-stage, HER2-positive breast cancer treated in China, suggesting that neoadjuvant therapy should be used in this patient population.

Marcela Mazo Canola, MD, discusses pivotal trials in early-stage and metastatic HER2-positive breast cancer, plus ongoing trials to watch.

The FDA has approved fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti–HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within 6 months of therapy completion.

Elias Obeid, MD, MPH, discusses the phase 3 KATHERINE trial in HER2-positive breast cancer.

Heather McArthur, MD, MPH, discusses key treatment developments in early-stage and metastatic HER2-positive breast cancer and triple-negative breast cancer, plus ongoing research at UT Southwestern Harold C. Simmons Comprehensive Cancer Center.

Mridula George, MD, discusses the variety of innovative HER2-positive breast cancer treatment options that have recently been approved or are undergoing investigation in clinical trials to broaden the standards of care for patients in this subgroup.

Sara A. Hurvitz, MD, medical oncologist and medical director at the Jonsson Comprehensive Cancer Center Clinical Research Unit, discussed pivotal findings in the HER2-positive treatment landscape that possess the potential to change practice.