ASCO 2015 Highlights

On December 18, 2019, the FDA accelerated the approval of enfortumab vedotin-ejfv (Padcev; Astellas Pharma), a Nectin-4–directed antibody and microtubule inhibitor conjugate, for the treatment of adults with locally advanced or metastatic urothelial cancer after immunotherapy with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy. These are the current standard treatments for patients with bladder cancer, the sixth most common cancer in the United States. Urothelial cancer accounts for >90% of bladder cancers.
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Orlando, FL—Tazemetostat (Tazverik), a first-in-class, oral, selective EZH2 inhibitor, has demonstrated single-agent antitumor activity in patients with relapsed or refractory follicular lymphoma, according to results of a phase 2 clinical trial presented at ASH 2019.
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Patients with anemia and lower-risk myelodysplastic syndromes (MDS) in whom first-line erythropoiesis-stimulating agents (ESAs) are not effective generally become transfusion dependent. Luspatercept-aamt (Reblozyl), a recombinant fusion protein that binds transforming growth factor beta superfamily ligands to reduce SMAD2 and SMAD3 signaling, was approved by the FDA in November 2019 and has been studied in this patient population with promising results.

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Orlando, FL—Nivolumab (Opdivo) monotherapy can be used as an effective bridge therapy to autologous stem-cell transplant (ASCT) in many patients with relapsed or refractory Hodgkin lymphoma, reported Matthew Mei, MD, Assistant Clinical Professor, Department of Hematology and Hematopoietic Cell Transplantation, City of Hope National Medical Center, Duarte, CA, at ASH 2019.
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Orlando, FL—The combination of the BCL2 inhibitor venetoclax (Venclexta) and intensive chemotherapy has demonstrated notable results in fit patients with newly diagnosed or relapsed or refractory acute myeloid leukemia (AML), according to results from a phase 1b/2 single-center clinical trial presented at ASH 2019.
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Orlando, FL—The combination of du­velisib (Copiktra) plus venetoclax (Venclexta) is a promising all-oral regimen for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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The discontinuation of oral oncology medications before the full-month supply has been finished results in medication waste, leading to increased costs for patients and for payers. Split fills allow for a 14- to 16-day supply for oral oncology medications rather than a full 28- to 30-day supply. Researchers compared the discontinuation rates, patient-reported adverse events, estimated pharmacy costs, and potential waste in patients with pharmacy benefit designs that included a split-fill option with patients who did not have this option (Staskon FC, et al. J Oncol Pract. 2019;15:e856-e862).

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Patient navigation is an increasingly recognized component of high-quality, patient-centered care. However, patient navigation in cancer programs is limited, often because of uncertainty about sustainable financial models to support these programs and defining the scope of practice. To demonstrate the benefits of patient navigation programs, researchers analyzed 5 real-world case studies (Kline RM, et al. J Oncol Pract. 2019;15:585-590).

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Orlando, FL—A potent, oral small-molecule bromodomain and extraterminal domain (BET) inhibitor—CPI-0610—improves spleen volume and symptoms when added to the Janus kinase (JAK) inhibitor ruxolitinib (Jakafi) in ruxolitinib-naïve patients with myelofibrosis. Ruxolitinib is the only FDA-approved treatment for myelofibrosis.
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Orlando, FL—The investigational dual-targeted CD38 chimeric antigen receptor (CAR) T-cell therapy achieved an objective response in more than 90% of patients with relapsed or refractory multiple myeloma who had received ≥3 previous therapies and whose disease had spread outside of the bone marrow. Furthermore, the therapy cleared extramedullary lesions in almost all patients with these lesions, according to results presented at ASH 2019.
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