HER2 Breast Cancer

With their final thoughts, the panelists provide key takeaways from their conversation regarding CDK4/6 inhibitor therapy in treatment of HR+/HER2- metastatic breast cancer.

Datopotamab deruxtecan (Dato-DXd; AstraZeneca, Daiichi Sankyo) also demonstrated improved overall survival compared to chemotherapy.

The combination regimen showed positive progression-free survival results among patients with HER2-positive breast cancer in the phase 3 HER2CLIMB-02 trial, but overall survival data have yet to mature.

There are currently no HER2-directed therapies for many HER2-expressing solid tumors that are refractory.

The trial was recommended to continue to analyze event-free survival rates, but current results are encouraging for treating estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.

Because of its prevalence in approximately 50% of breast cancers, the outcomes of HER2-low treatment have a significant impact on patient outcomes.

Trastuzumab deruxtecan was approved by the FDA for HER2-low breast cancer treatment in 2022 and could also benefit some patients with hormone receptor-positive or triple-negative disease.

Indication for abemaciclib (Verzenio; Eli Lilly and Company) in combination with endocrine therapy expanded for the adjuvant treatment of adults with hormone receptor–positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer with a high risk of recurrence.

HER2-low disease demands a different approach from that of HER2-negative disease.

Sacituzumab govitecan-hziy (Trodelvy) is a conjugated Trop-2-directed antibody and topoisomerase inhibitor previously approved for patients with triple-negative breast cancer.

The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive (ER+), HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.

This is the first indication for tucatinib that extends beyond the treatment of advanced unresectable or metastatic HER2-positive breast cancer.

Long-term data showed no difference in the clinical benefit between the treatments for HER2-negative early breast cancer with homologous recombination deficiency.

Following a phase 2 analysis of OP-1250 with palbociclib, researchers recommend an OP-1250 dose level of 120 mg/day for future trials.

Guidelines for HER2-low expressed cancer could define who and how patient recieve drugs, said expert live from San Antonio Breast Cancer Symposium 2022.

The phase 3 clinical trial shows that the 5-year OS for patients with HR+/HER2- advanced breast cancer in the abemaciclib plus fulvestrant group was 41.2% vs 29.2% for the placebo arm.

Results from the phase 3 CAPItello-291 clinical trial show that the combination doubled the median progression-free survival compared with the placebo in patients with HR-positive, HER2-negative advanced breast cancer.

BYLieve clinical trial data indicate long-term and very-long-term data disease control was observed in 25.6% and 16.5% of patients, respectively, with PFS at 24.8 and 29.4 months in patients with HR-positive, HER2-negative advanced breast cancer.

The FDA approved the only companion diagnostic that is indicated to assess low levels of HER2 proteins in patients with metastatic breast cancer.

New TROPiCS-02 data for Gilead treatment demonstrates progression-free survival benefit, regardless of HER2 status.

The drug also meets the key secondary endpoint of improved overall survival for treatment for individuals with HER2 positive unresectable and/or metastatic breast cancer.

Gilead Sciences Inc submitted a supplemental Biologics License Application to the FDA for sacituzumab govitecan-hziy (Trodelvy) following promising trial results.

The FDA approved a new drug that treats unresectable and metastatic HER2-low breast cancer, giving patients with this new subtype a treatment beyond chemotherapy.

Trastuzumab deruxtecan is an engineered HER2-directed antibody drug conjugate being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.

Dutch biopharmaceutical company Byondis submitted the BLA for [vic-]trastuzumab duocarmazine (SYD985) in the treatment of patients with HER2-positive metastatic breast cancer with the goal of improving patient outcomes.