HER2 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.

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.

The FDA has approved fam-trastuzumab deruxtecan-nxki (Enhertu) for previously treated HER2-positive breast cancer and gastric or gastroesophageal junction adenocarcinoma.

Findings suggest that the HER2 L755S mutation plays a role in the aggressiveness of lobular breast cancer observed in the clinic.

As part of the submission, the companies have also requested priority review with the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

Palbociclib is indicated for adults in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men.

The drug combination achieved a median overall survival of more than 5 1/2 years in the first-line setting for postmenopausal women with HR+/HER2- aBC1, the company says.

Trastuzumab deruxtecan (Enhertu) approved for adult patients with unresectable or metastatic HER2-positive breast cancer who were previously administered an anti–HER2-based regimen.

Up to 50% of all patients with breast cancer have tumors with a HER2 immunohistochemistry level not currently eligible for HER2-targeted therapy.

New therapies and combination regimens may allow a more tailored approach.

Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR-positive/HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Abemaciclib (Verzenio; Lilly) is the first addition to adjuvant endocrine therapy approved by the FDA in two decades.

Trastuzumab (Herceptin, Herzuma, Kanjinti, Ogivri, Ontruzant) is a HER2/neu receptor antagonist indicated for early and advanced breast cancer, advanced stomach cancer, and gastroesophageal junction cancer.

BRACAnalysis CDx assay is indicated for use as a companion diagnostic to select patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer who may derive clinical benefit from olaparib.

Olaparib (Lynparza) approved for patients with germline BRCA-mutated, HER2-negative, high-risk early breast cancer.

Phase 3 TROPiCS-02 study continues to follow patients for overall survival, a key secondary endpoint.

Trastuzumab deruxtecan demonstrated clinically meaningful and statistically significant improvements in overall and progression-free survival, the company says.

Olaparib is a first-in-class PARP inhibitor and is the first targeted treatment to block DNA damage response in cells or tumors with a deficiency in homologous recombination repair.

Pyrotinib combined with capecitabine found to improve overall survival in patients with previously treated HER2-positive metastatic breast cancer.