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KEYNOTE-522: Neoadjuvant and Adjuvant Pembrolizumab in TNBC

In In The News by Barbara Jacoby

By: Joyce A. O’Shaughnessy, MD, Sara A. Hurvitz, MD From: onclive.com Expert perspectives on adjuvant and neoadjuvant use of pembrolizumab in the KEYNOTE-522 study in triple-negative breast cancer. Transcript: Joyce A. O’Shaughnessy, MD: Let’s go on to the third data set, which is the KEYNOTE-522. We’re finally getting a big advance for patients with high-risk TNBC [triple-negative breast cancer] in …

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FDA Approves Pembrolizumab for High-Risk Early-Stage TNBC Plus Chemo as Neoadjuvant Treatment, Then as Single-Agent Adjuvant Treatment

In Clinical Studies News by Barbara Jacoby

By: Kristi Rosa From: onclive.com The FDA has approved 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 FDA has approved pembrolizumab (Keytruda) for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination …

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FDA Approvals Sought for 2 Pembrolizumab Indications in TNBC

In Clinical Studies News by Barbara Jacoby

By: Kristi Rosa From: onclive.com The FDA has accepted 2 supplemental biologics applications (sBLAs) for pembrolizumab (Keytruda) in patients with triple-negative breast cancer (TNBC); these are the first US applications for the anti–PD-1 therapy in breast cancer, according to an announcement from Merck, the drug developer.1 Specifically, the regulatory agency has accepted and granted priority review to a new sBLA …

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Merck Announces Two US Regulatory Milestones for KEYTRUDA® (pembrolizumab) in Triple-Negative Breast Cancer (TNBC)

In Clinical Studies News by Barbara Jacoby

From: businesswire.com FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for KEYTRUDA Plus Chemotherapy for the Treatment of Certain Patients With Metastatic TNBC Based on KEYNOTE-355 Trial FDA Accepts sBLA for KEYTRUDA for the Treatment of Patients with High-Risk Early-Stage TNBC Based on KEYNOTE-522 Trial Merck (NYSE: MRK), known as MSD outside the United States and Canada, today …

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First Trial of Immunotherapy in Early-Stage Triple-Negative Breast Cancer Shows Promising Results

In Clinical Studies News by Barbara Jacoby

By: Danielle Ternyila From: targetedonc.com In an interview with Targeted Oncology, Peter Schmid, MD, PhD, discussed the findings from the interim analysis for the phase III KEYNOTE-522 study, which added pembrolizumab to neoadjuvant chemotherapy in patients with early-stage triple-negative breast cancer. The randomized, phase III KEYNOTE-522 clinical trial evaluated the benefit of adding the immune checkpoint inhibitor pembrolizumab (Keytruda) to …

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Adjuvant I/O in TNBC

In Clinical Studies News by Barbara Jacoby

Insights: Sara M. Tolaney, MD, MPH From: onclive.com Very recently, we’ve seen some exciting data that came out from KEYNOTE-522, which looked at a preoperative trial of adding pembrolizumab to chemotherapy in patients with triple-negative breast cancer. In this trial, patients received chemotherapy with anthracycline, Cytoxan, taxane, and platinum and then were randomized to receive that chemo [chemotherapy] backbone with …

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Immunotherapy Comes of Age in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Brittany Lovely From: onclive.com Breast cancer has historically been an immunologically cold disease, but recent and emerging data are carving out a space for several immunotherapies in the treatment paradigm. As the understanding of subtype response to treatment expands, so has exploration into antitumor immune response in patient subpopulations, especially in those with triple-negative breast cancer (TNBC). “When IL-2 …

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Immunotherapy Active in Early Stage Triple Negative Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Liam Davenport From: medscape.com New hope for patients with triple negative breast cancer (TNBC) has been raised with results showing that immunotherapy has activity in early stage disease, after they were raised last year — and then subsequently dashed — by results with immunotherapy in the metastatic setting. TNBC accounts for 15% of breast cancer cases, but unlike other …

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Keytruda Plus Chemo Shows High Response Rate in Triple-Negative Breast Cancer

In Clinical Studies News by Barbara Jacoby

From: specialtypharmacytimes.com Pembrolizumab (Keytruda, Merck) plus chemotherapy demonstrated a statistically significant improvement in pathological complete response rate (pCR) as a neoadjuvant therapy in patients with triple-negative breast cancer (TNBC), according to new data from a phase 3 study. Approximately 15% to 20% of patients with breast cancer are diagnosed with TNBC, which can be more difficult to treat than other …

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Merck Data Are Another Step for Immunotherapy in Breast Cancer

In Clinical Studies News by Barbara Jacoby

From: xconomy.com Merck this morning announced that a combination of its drug pembrolizumab (Keytruda) and chemotherapy succeeded in a Phase 3 study in breast cancer, a potentially notable advance for immunotherapy in treating the disease. Merck (NYSE: MRK) said that Keytruda and chemotherapy beat chemo alone when given to patients with triple-negative breast cancer in a study called Keynote-522. The …