The Lynx Group

Breast Cancer

On December 16, 2020, the FDA approved margetuximab-cmkb (Margenza; MacroGenics) in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer who have received ≥2 previous anti-HER2 regimens, of which at least 1 was for metastatic disease. The application for this approval received a fast-track designation.
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On November 13, 2020, the FDA accelerated the approval of pembrolizumab (Keytruda; Merck), a PD-1 inhibitor, plus chemotherapy, for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in patients with PD-L1 (combined positive score [CPS] ≥10), as determined by an FDA-approved test.
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Early locoregional therapy with surgery and radiation does not improve overall survival (OS) in women with newly diagnosed stage IV breast cancer and an intact primary tumor compared with systemic therapy alone, according to the results of the randomized ECOG-ACRIN E2108 phase 3 clinical trial.
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Pembrolizumab (Keytruda) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy alone as a first-line treatment for patients with metasstatic triple-negative breast cancer (TNBC) whose tumors express PD-L1.
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The combination of the checkpoint inhibitor durvalumab (Imfinzi), the poly ADP-ribose polymerase (PARP) inhibitor olaparib (Lynparza), and chemotherapy with paclitaxel used as neoadjuvant therapy improved the pathological complete response (pCR) of patients with high-risk HER2-negative stage II or III breast cancer compared with the physician’s choice of chemotherapy.
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San Antonio, TX—Although capecitabine (Xeloda) is approved for metastatic breast cancer, it is not clear whether it should be used in early breast cancer, and its optimal role remains to be established. A large meta-analysis sheds some light on this issue, demonstrating that capecitabine improves disease-free survival (DFS) and overall survival (OS) for patients with triple-negative breast cancer (TNBC) when added to other systemic therapies, but not as a substitute for other therapies.
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Miami, FL—With too much red tape regarding genetic (ie, hereditary) testing, not enough people are being identified before they have breast cancer, according to Kevin Hughes, MD, FACS, Co-Director, Avon Comprehensive Breast Evaluation Center, Massachusetts General Hospital, Boston.
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San Antonio, TX—The investigational oral drug tucatinib reduced the risk for death by 33% and the risk for disease progression or death by 50% when added to trastuzumab (Herceptin) plus capecitabine (Xeloda) in patients with heavily pretreated advanced HER2-positive breast cancer, with or without brain metastasis.

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San Antonio, TX—The novel antibody– drug conjugate trastuzumab deruxtecan (Enhertu) achieved “unprecedented” objective response rates of 60.9%, a median duration of response of 14.8 months, and a median progression- free survival (PFS) of 16.4 months in heavily pretreated patients with HER2-positive metastatic breast cancer, according to the results of the phase 2 DESTINY-Breast01 trial. The disease control rate was 97% in these patients whose disease progressed while receiving HER2-targeted agents, such as trastuzumab (Herceptin), ado-trastuzumab emtansine (T-DM1; Kadcyla), or pertuzumab (Perjeta).
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The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer.
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