BREAST CANCER

In the wake of immunotherapy combinations becoming available in breast cancer, including triple-negative breast cancer, the Society for Immunotherapy of Cancer has published clinical practice guidelines for physicians treating in this setting.

The FDA has issued a complete response letter to the developer of eflapegrastim, for which a biologics license application was submitted for the treatment of chemotherapy-induced neutropenia. The FDA has cited manufacturing deficiencies and is requiring that the facilities be reinspected.

The FDA has granted approval to pembrolizumab for the treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

The combination of the ant-PD-1 inhibitor, pembrolizumab plus chemotherapy before surgery continued by pembrolizumab as a single agent led to statistically significant event-free survival result versus neoadjuvant chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer.

Regardless of age the combination of ribociclib and endocrine therapy led to improved overall survival in pre- or postmenopausal patients with hormone receptor-positive, HER2-negative advanced breast cancer.

Encouraging findings from theTROPION-PanTumor01 trial revealed a positive response and safety profile for the antibody-drug conjugate datopotamab deruxtecan in patients with triple-negative breast cancer.

Treatment with atezolizumab plus carboplatin demonstrated early clinical activity in patients with metastatic invasive lobular breast cancer, with slight trends toward increased clinical benefit in patients with triple-negative ILC and responders with higher PD-L1 expression.

Balixafortide in combination with eribulin did not improve objective response rate compared to eribulin alone for the treatment of HER2-negative, locally recurrent or metastatic breast cancer, missing the coprimary end point of the FORTRESS study.

Hope Rugo, MD, continues to discuss key clinical trials affecting metastatic triple-negative breast cancer, including IMpassion131.

An expert in breast oncology discusses the IMpassion130 and KEYNOTE-355 clinical trials.

Dr Rugo educates on early stage treatment options and molecular testing guidelines for patients with metastatic triple-negative breast cancer.

Hope Rugo, MD, discusses the case of a 49-year-old woman diagnosed with metastatic triple-negative breast cancer.

An FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.

Treatment with [vic-]trastuzumab duocarmazine (SYD985) demonstrated a statistically significant improvement in progression-free survival compared with physician’s choice of treatment in patients with pretreated HER2-positive unresectable locally advanced or metastatic breast cancer, meeting the primary end point of the phase 3 TULIP study, according to a press release from Byondis B.V.

The panel of experts in breast cancer discuss enrollment of patients with TNBC in clinical trials, including considerations and barriers.

Experts in the field of breast cancer review the role of genetic testing in the selection of treatment for patients with TNBC.

Ruta Rao, MD, discusses practical considerations regarding the use of sacituzumab govitecan in patients with relapsed/refractory TNBC.

The panel of experts share their treatment recommendations for patients with residual disease after an incomplete response to TNBC therapy.

Pathologist David G. Hicks, MD, discusses the impact of residual disease in breast cancer treatment outcomes.

Elizabeth Mittendorf, MD, PhD, and Ruta Rao, MD, present the case of a 48-year-old woman with stage T2N1 TNBC.

Benefit was maintained in progression-free survival, overall survival, and objective response rate with the antibody-drug conjugate sacituzumab govitecan over physician’s choice of therapy, regardless of the chemotherapy agent used.

Across 3 HER2-negative biomarker signature groups, treatment with intra-tumoral SD-101 in combination with pembrolizumab and paclitaxel increased estimated pathological complete response rates in patients with high-risk, HER2-negative stage II/III breast cancer, but the results were not considered significant, according to findings from the phase 2 I-SPY 2 trial.

Investigators in the PALOMA-3 trial have concluded that Palbociclib plus fulvestrant maintains a clinically meaningful long-term overall survival benefit for patients with either HR+ or HER2 negative breast cancer.

Patients with early-stage breast cancer who have ultralow risk disease, indicated by a 70-gene signature, demonstrated an excellent survival prognosis regardless of clinical risk.

New results, presented at the 2021 ASCO annual meeting, show the benefit of adding durvalumab to neoadjuvant anthracycline and taxane–based chemotherapy for patients with early triple-negative breast cancer.