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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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Soliman Details Ongoing Novel Immunotherapeutic Research Efforts at Moffitt, Recent Developments in Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Hayley Virgil From: onclive.com Moffitt Cancer Center is currently working to develop a host of novel therapeutic treatments within the breast cancer space, from immunotherapeutics to personalized cancer vaccines, according to Hatem Soliman, MD. Findings from the KEYNOTE-355 trial show that pembrolizumab (Keytruda) induced positive outcomes in the first-line setting. The PD-1 inhibitor improved progression-free survival (PFS) when combined …

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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 OKs Pembrolizumab in Advanced TNBC

In Clinical Studies News by Barbara Jacoby

By: Ian Ingram From: medpagetoday.com Checkpoint inhibitor nabs accelerated approval for PD-L1 expressors The FDA on Friday granted accelerated approval to pembrolizumab (Keytruda) for treating triple-negative breast cancer (TNBC) patients with metastatic or locally recurrent unresectable disease. TNBC becomes the astonishing 18th cancer indication for pembrolizumab, which was first approved in 2014 for advanced or unresectable melanoma. Pembrolizumab, a PD-1-directed …

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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’s Keytruda sBLA for Tumor Mutation Burden-High Cancer Patients Accepted by FDA

In Clinical Studies News by Barbara Jacoby

By: Staff Reporter From: precisiononcologynews Merck announced on Tuesday that the US Food and Drug Administration has accepted its supplemental biologics license application for the accelerated approval of pembrolizumab (Keytruda) as a monotherapy for previously treated cancer patients who have a high tumor mutational burden. The agency also granted priority review for the sBLA, and Merck expects to hear back …

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Immune therapy reduces risk of recurrence in aggressive breast cancer

In In The News by Barbara Jacoby

By: Queen Mary, University of London From: medicalxpress.com An immune therapy for the most aggressive form of breast cancer can substantially reduce the risk of the disease returning, according to a clinical trial led by Professor Peter Schmid of Queen Mary University of London. The research is published today in the New England Journal of Medicine. Patients with early triple …

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Potential Immunotherapy Response Markers Emerge in Metastatic Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: Ellie Leick From: onclive.com Data suggest that baseline T-cell clonality and exhaustion markers have significant translational relevance and can serve as prognostic factors of response to pembrolizumab (Keytruda) as maintenance therapy in metastatic breast cancer, explained James M. Reuben, PhD, MBA. In a phase II trial that was presented at the 2019 San Antonio Breast Cancer Symposium, patients with …

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FDA Panel Supports Pembrolizumab for High-Risk NMIBC

In Clinical Studies News by Barbara Jacoby

By: Jason M. Broderick From: onclive.com The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9 to 4 supporting the approval of a new drug application (NDA) for pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)–unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or chose to …

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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 …