The Lynx Group

Breast Cancer

Results of the SWOG S1007 RxPONDER clinical trial suggest that many postmenopausal women with early-stage hormone receptor (HR)-positive, HER2-negative breast cancer, and 1 to 3 positive axillary lymph nodes may be able to avoid adjuvant chemotherapy. By contrast, premenopausal women can derive benefit from adjuvant chemotherapy, based on findings of a prespecified interim analysis of the phase 3 RxPONDER clinical trial; the findings were presented at the 2020 San Antonio Breast Cancer Symposium.
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The addition of the cyclin-dependent kinase (CDK)4/6 inhibitor abemaciclib (Verzenio) to standard endocrine therapy reduced the risk for invasive disease recurrence or death compared with endocrine therapy alone by almost 30% in patients with high-risk, hormone receptor (HR)-positive, HER2-negative early breast cancer. These results come from the primary analysis of the phase 3 monarchE clinical trial that was presented at the 2020 San Antonio Breast Cancer Symposium.
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Sacituzumab govitecan (Trodelvy) led to increased response rates and improved progression-free survival (PFS) compared with chemotherapy in heavily pretreated patients with metastatic triple-negative breast cancer (TNBC) and stable brain metastases, according to a subgroup analysis of the phase 3 ASCENT clinical trial. The drug did not lead to improved overall survival (OS) in patients with stable brain metastases. These results were presented at the 2020 San Antonio Breast Cancer Symposium (SABCS).
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Pembrolizumab (Keytruda) plus chemotherapy improved progression-free survival (PFS) compared with chemotherapy alone as first-line treatment of metastatic triple-negative breast cancer (TNBC), according to the results of KEYNOTE-355. Improvement in PFS with the addition of pembrolizumab to chemotherapy was more robust in patients with TNBC and PD-L1 expression. These results from KEYNOTE-355 were presented at the 2020 San Antonio Breast Cancer Symposium (SABCS) and add to a growing body of evidence supporting the first-line use of pembrolizumab plus chemotherapy combinations for TNBC.
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A small-molecule CD73 inhibitor (AB680) induced a 41% overall response rate (ORR) when combined with chemotherapy (with nab-paclitaxel and gemcitabine), plus the novel PD-1 inhibitor zimberelimab, as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma, according to results of the dose-escalation portion of a phase 1/1b study known as ARC-8.
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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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