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Ilixadencel Added to Sunitinib Shows Positive OS Trend in RCC

In Clinical Studies News by Barbara Jacoby

By: Gina Columbus From: onclive.com The addition of the off-the-shelf cancer immune primer ilixadencel to sunitinib (Sutent) trended toward a benefit in overall survival (OS) compared with sunitinib alone as a first-line treatment for patients with newly diagnosed metastatic renal cell carcinoma (RCC), according to updated results of the phase II MERECA trial (NCT02432846) presented during the 2020 ASCO-SITC Clinical …

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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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Gilead to get speedy FDA review for second CAR-T cell therapy in lymphoma

In Clinical Studies News by Barbara Jacoby

By: Alaric DeArment From: medcitynews.com The biotech company’s Kite Pharma subsidiary said the FDA had granted priority review for KTE-X19 in mantle cell lymphoma. The company already markets the CAR-T Yescarta for diffuse large B-cell lymphoma. A subsidiary of Gilead Sciences could have its second CAR-T cell therapy on the market by this summer if the Food and Drug Administration …

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FDA Grants Priority Review to Capmatinib in METex14+ NSCLC

In Clinical Studies News by Barbara Jacoby

By: Jason M. Broderick From: onclive.com The FDA has granted a priority review designation to a new drug application (NDA) for capmatinib (INC280) for use as treatment for newly diagnosed and previously treated patients with locally advanced or metastatic MET exon14 skipping (METex14)—mutated non–small cell lung cancer (NSCLC).1 The priority designation, which will expedite the review and development of capmatinib …

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Novel Drug May Reverse Breast Cancer Hormone Therapy Resistance

In Clinical Studies News by Barbara Jacoby

Original story from Breast Cancer Now From: technologynetworks.com A novel drug based on a natural compound found in broccoli, kale and other cruciferous vegetables could hold the key to reversing or even preventing resistance to breast cancer hormone therapy, new research has found. Scientists from the University of Manchester found that drug SFX-01 – which has shown promise in a …

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National Brain Tumor Society to Provide Funding for ONC201 Trial in EGFR-Independent High-Grade Gliomas

In Clinical Studies News by Barbara Jacoby

Oncoceutics announced that the National Brain Tumor Society (NBTS) has committed to providing more than $200,000 in funding, with the potential for multiple years, to support a Phase II clinical trial of ONC201, the first imipridone dopamine receptor D2 antagonist (DRD2), in a molecular subset of high grade gliomas. The future clinical trial will evaluate the efficacy of single agent …

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University Hospitals Seidman Cancer Center Treats Its First Glioblastoma Patient With Genetically Modified Poliovirus

In Clinical Studies News by Barbara Jacoby

Source: PR Newswire From: yahoo.com One of only four medical institutions participating in this groundbreaking Phase II clinical trial University Hospitals Seidman Cancer Center treated its first patient in a new clinical trial to validate the groundbreaking effects of the poliovirus on glioblastoma (GBM), a deadly Grade IV cancer of the brain. UH is the only Midwest site participating in …

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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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Overcoming AI Resistance in ESR1-Mutant Breast Cancer

In Clinical Studies News by Barbara Jacoby

By: CAROLINE SEYMOUR From: oncnursingnews.com Resistance to aromatase inhibitors (AIs) is a growing concern in patients with advanced hormone receptor (HR)–positive, HER2-negative breast cancer, said Hope S. Rugo, MD, FASCO, who added that although fulvestrant (Faslodex) has shown some activity in patients who develop ESR1 mutations, more effective treatment options are needed. One such drug that has emerged in this space is …

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Clinical Efficacy of Weekly ONC201 in Adult Recurrent Glioblastoma Published

In Clinical Studies News by Barbara Jacoby

Oncoceutics, Inc. announced that results from the second and third cohort of the Phase II trial for patients with recurrent glioblastoma treated with the company’s lead imipridone, ONC201, were recently published in the journal Neuro-Oncology. This manuscript represents the third publication among a series of reports demonstrating durable radiographic regressions with ONC201 in patients with H3 K27M-mutant glioma. The study …