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Nelipepimut-S in combination with granulocyte-macrophage colony-stimulating factor demonstrated doubling of the difference in the increase in antigen-specific CD8 cytotoxic T-lymphocytes in patients with ductal carcinoma in situ of the breast who were HLA-A2-positive or A3-positive, express HER2 at immunohistochemistry1+, 2+, or 3+ levels, and are pre- or post-menopausal, according to preliminary results from the phase II VADIS study.

From 2001 to 2017, the cancer death rates continued to decline in the United States, and these decreases were observed in all major racial and ethnic groups, as well as in males, females, adolescents, young adults, and children. However, the rates of cancer incidence for all cancers slightly increased in females from 2012 to 2016, according to the Annual Report to the Nation on the Status of Cancer, which was published in&nbsp;Cancer.<sup>&nbsp;</sup>

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

Despite evidence from previous studies that showed that platinum-based chemotherapy agents are active in patients with breast cancer, platinum-based chemotherapy was not found to be superior to standard chemotherapy in terms of eliciting pathologic complete responses in patients with HER2-negative breast cancer carrying a&nbsp;BRCA&nbsp;mutation, according to data from the INFORM trial published in the&nbsp;Journal of Clinical Oncology.

The combination of fulvestrant and capivasertib prolonged progression-free survival compared with placebo in patients with estrogen receptor-positive breast cancer who were previously treated with aromatase inhibition, according to results from the phase II FAKTION trial, published in&nbsp;The Lancet Oncology.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

The FDA has granted Priority Review to the New Drug Application for the combination of tucatinib, trastuzumab, and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The prescription Drug User Fee Act, the FDA has set a target action date of August 20, 2020.&nbsp;

First-line treatment with pembrolizumab in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in patients with metastatic triple-negative breast cancer who had PD-L1 expression in their tumors, meeting one of the coprimary end points of the phase III KEYNOTE-355 trial, according to the results of an interim analysis reported in a press release from Merck.

Patients with metastatic breast cancer who carry rare mutations identified by circulat&shy;ing tumor DNA responded to matched targeted therapies, according to results of the plasmaMATCH trial presented during the 2019 San Antonio Breast Cancer Symposium.&nbsp;Specifically, patients with HER2 mutations responded to neratinib and patients with AKT1 mutations responded to capivasertib.