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FDA place clinical hold on all checkpoint inhibitor combination trials for myeloma patients

The U.S. Food and Drug Administration (FDA) has placed clinical holds on all trials investigating checkpoint inhibitors in combination with immunomodulatory (IMiD) drugs for the treatment of myeloma patients. This decision follows the recent suspension of clinical trials investigating pembrolizumab (Keytruda®) in combination with IMiD drugs as a treatment for myeloma patients, after higher death…

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Autolus announces completion of first-dose cohort in CAR-T cell therapy trial

The biopharmaceutical company, Autolus, has announced it has completed the first-dose cohort of patients in its Phase I/II APRIL study investigating AUTO2 as a treatment for relapsed and/or refractory myeloma patients. AUTO2 is a novel dual-targeted chimeric antigen receptor T-cell (CAR-T cell) therapy that targets both B-cell maturation antigen (BCMA) and transmembrane activator and calcium…

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Study demonstrates prognostic value of IMiD-14 gene expression profile signature for myeloma patients

Results from a retrospective study, published in The Lancet Haematology, have been used to develop a gene expression profile signature which has the potential to predict response to immunomodulatory (IMiD) treatment in myeloma patients. Researchers analysed data from newly diagnosed myeloma patients receiving IMiD drugs in a clinical trial setting and identified 176 genes which…

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NICE issues second draft ‘no’ for ixazomib as a treatment for relapsed and refractory myeloma patients

The National Institute for Health and Care Excellence (NICE) has issued a second draft guidance not recommending the use of ixazomib in combination with lenalidomide (Revlimid®) and dexamethasone as a treatment for myeloma patients who have received at least one prior treatment. The appraisal consultation document states that, from the available evidence, it is not…

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Take part in the UK imaging practice survey

The British Society of Haematology (BSH) guideline committee is inviting haematology consultants and nurses to complete a 5-minute survey, which aims to analyse current UK imaging practice for assessing myeloma. This follows on from the recently updated guidelines from the National Institute of Health and Care Excellence (NICE) for the diagnosis and management of myeloma,…

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Investigational new drug applications submitted to FDA

Two investigational new drug (IND) applications have been submitted to the U.S. Food and Drug Administration (FDA) this month. The biopharmaceutical company, Kite Pharma, have submitted an IND application to set up a Phase I trial to test KITE-585 for relapsed and/or refractory myeloma. KITE-585 is a CAR-T cell therapy that targets B-cell maturation antigen…

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Genmab report positive results from Phase III daratumumab trial for myeloma patients

The Danish biotechnology company, Genmab, have announced that the Phase III trial, ALCYONE, has achieved its primary endpoint of improving progression-free survival in newly diagnosed myeloma patients. This study compared daratumumab (Darzalex®) in combination with bortezomib (Velcade®), melphalan and prednisone (VMP) to VMP alone. Treatment including daratumumab was demonstrated to reduce the risk of disease…

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