The lancet oncology
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The lancet oncology · Dec 2024
ReviewNavigating the oncology drug discovery and development process with programmes supported by the National Institutes of Health.
The translation of basic drug discoveries from laboratories to clinical use presents substantial challenges. Factors such as insufficient funding, misdirected project focus, and inability to understand a drug's limitations or strengths contribute to the difficulty of this process. To address these issues, the National Institutes of Health (NIH) has established various resources dedicated to streamlining drug development. ⋯ The NIH also provides access to key resources through various programmes, such as the Developmental Therapeutics Program, focusing on preclinical drug discovery and the Cancer Therapy Evaluation Program, which oversees clinical trial efforts for investigational agents. These resources might include funding opportunities, access to a network of scientific experts, and services to address gaps in scientific work. This Review explores the diverse platforms and resources available at the NIH and outlines how researchers can leverage them to expedite the drug development process.
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The lancet oncology · Dec 2024
Multicenter StudyValemetostat monotherapy in patients with relapsed or refractory non-Hodgkin lymphoma: a first-in-human, multicentre, open-label, single-arm, phase 1 study.
Few treatment options exist for patients with non-Hodgkin lymphoma, and outcomes remain poor for relapsed or refractory disease. We evaluated the safety and preliminary clinical activity of valemetostat, a novel inhibitor of EZH2 and EZH1, in patients with relapsed or refractory non-Hodgkin lymphomas. ⋯ Daiichi Sankyo.
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The lancet oncology · Dec 2024
Multicenter StudyShort-course hypofractionated proton beam therapy, incorporating 18F-DOPA PET and contrast-enhanced MRI targeting, for patients aged 65 years and older with newly diagnosed glioblastoma: a single-arm phase 2 trial.
Older patients (aged ≥65 years) with glioblastoma have a worse prognosis than younger patients and a median overall survival of 6-9 months. 3,4-Dihydroxy-6-[18F]fluoro-L-phenylalanine (18F-DOPA) PET sensitively and specifically identifies metabolically active glioblastoma for preferential targeting. Proton beam therapy potentially improves quality of life (QOL) by sparing more healthy brain tissue than photon radiotherapy. With improved targeting and the dosimetric advantages of proton beam therapy, we aimed to test whether hypofractionated proton beam therapy could improve survival and QOL in older patients with glioblastoma. ⋯ Mayo Clinic Marley Endowment Funds and the Lawrence W and Marilyn W Matteson Fund in Cancer Research.
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The lancet oncology · Dec 2024
Multicenter StudyAlpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study.
Alpelisib, a PI3Kα-selective inhibitor and degrader, plus fulvestrant showed efficacy in hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer in SOLAR-1; limited data are available in the post-cyclin-dependent kinase 4/6 inhibitor setting. BYLieve aimed to assess alpelisib plus endocrine therapy in this setting in three cohorts defined by immediate previous treatment; here, we report results from cohort A. ⋯ Novartis Pharmaceuticals.
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The lancet oncology · Dec 2024
Multicenter StudyValemetostat for patients with relapsed or refractory peripheral T-cell lymphoma (VALENTINE-PTCL01): a multicentre, open-label, single-arm, phase 2 study.
Peripheral T-cell lymphomas are aggressive non-Hodgkin lymphomas with few treatment options for relapsed or refractory disease. Valemetostat tosylate (valemetostat) is a potent, novel, dual inhibitor of EZH2 and EZH1. We investigated the clinical activity and safety of valemetostat in patients with relapsed or refractory peripheral T-cell lymphoma, and its safety in patients with relapsed or refractory adult T-cell leukaemia/lymphoma. ⋯ Daiichi Sankyo.