The Lynx Group

August 2016, Vol 7, No 7, Special Issue: Payers’ Perspectives in Oncology

On April 11, 2016, the FDA approved venetoclax (Venclexta; Janssen) tablets, a first-in-class BCL-2 inhibitor for the treatment of patients with CLL plus chromosome 17p deletion, as detected by an FDA-approved test (Vysis CLL FISH probe kit), who have received at least 1 previous therapy.
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Many significant and interesting topics highlighted at ASCO 2016 are discussed in this publication, covering clinical, safety, and economic issues related to cancer therapies.
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Men with intermediate-risk prostate cancer can safely undergo radiation administered in larger fractions for 4 weeks (moderate hypofractionation) as an alternative to conventional radiation administered for 8 weeks, according to the results of a randomized, controlled, noninferiority clinical trial presented at ASCO 2016.
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The first randomized trial to compare robotic-assisted prostatectomy with conventional open radical prostatectomy found no meaningful differences between these techniques in urinary and sexual function or in the rate of positive surgical margins in men with localized prostate cancer in the first 12 weeks after surgery (Yaxley JW, et al. Lancet. 2016 Jul 26. Epub ahead of print).
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Evidence is mounting that 2 immunotherapies are better than 1 as first-line treatment of patients with advanced melanoma. A phase 3 clinical trial showed that nivolumab plus ipilimumab was superior to ipilimumab or nivolumab alone, and a phase 1 trial suggests that pembrolizumab can be safely and effectively used in combination with other drugs as first-line treatment in this setting. Both studies were presented at ASCO 2016.
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Interim results from a phase 1b study indicate that the investigational monoclonal antibody isatuximab, in combination with lenalidomide and dexamethasone, achieves responses in >50% of patients with relapsed or refractory multiple myeloma, including those with disease refractory to immunomodulatory drugs (IMiDs).
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Adding the recently approved daratumumab (Darzalex), a human, CD38-directed monoclonal antibody, to a standard regimen of bortezomib (Velcade) and dexamethasone improved progression-free survival (PFS) by >60% compared with the standard regimen in patients with relapsed or refractory multiple myeloma, according to Antonio Palumbo, MD, Chief of the Multiple Myeloma Unit, University of Torino, Italy.
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Chimeric antigen receptor (CAR) T-cells have saved lives in some patients with acute lymphoblastic leukemia (ALL) who had run out of other treatment options. This type of immunotherapy is making inroads in other hematologic malignancies as well, but it is still being studied in very sick patients.
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A durable complete response was achieved in a high proportion of adults with refractory B-cell malignancies who received CD19+ chimeric antigen receptor (CAR) T-cells made up of a defined 1:1 ratio of CD8+ and CD4+ cells.
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