At the 61st annual meeting of the American Society of Hematology in December 2019, nearly 5,000 abstracts were presented. Among this massive volume of research were several studies that had significant implications for community oncology practices. Additionally, researchers from Cardinal Health Specialty Solutions presented research showcasing both real-world experiences on CAR-T therapies among underrepresented patient populations and barriers to adoption of these therapies among community oncologists.
Vice President and Senior Medical Director Ajeet Gajra, MD, FACP, and Marjorie Zettler, PhD, MPH, Director of Research Strategy for Cardinal Health Specialty Solutions, compiled some of the most notable findings here.
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While results from this phase 2 study cannot be considered practice-changing, it addresses several critical issues in CLL management:
- It utilizes uMRD as a valid end-point in CLL
- Given the concerns of long-term adverse effects and financial burden from lifelong therapy with ibrutinib, it investigates the role of time-limited therapy in first line therapy of CLL by evaluating the proportion of patients treated with 15 cycles achieving uMRD status
- It evaluates whether discontinuation of therapy after achievement of unMRD status is safe. To address this issue, the study randomized patients with uMRD to receive ibrutinib or placebo, but those results are awaited. The study also found high levels of uMRD across subgroups, including these high-risk patients: deletion 17p, 75 percent; deletion 17p or TP53 mutation, 70 percent: deletion 11q, 84 percent; complex karyotype, 83 percent, and unmutated IGHV, 81 percent.
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Daratumumab, a CD38-directed cytolytic antibody has demonstrated activity with various combinations of immunomodulatory agents (IMids) and proteasome inhibitors (PIs) leading to multiple approved indications in multiple myeloma.
In the phase 3 CANDOR trial, the addition of daratumumab to carfilzomib and dexamethasone (KdD) reduced the risk of disease progression or death compared with carfilzomib and dexamethasone alone (Kd). 90 percent of patents had prior bortezomib and 42 percent of patients had prior lenalidomide. One-third of patients were lenalidomide-refractory. The progression free survival (PFS) benefit of KdD was maintained in both lenalidomide-exposed and -refractory patients. Notably, prior treatment with anti-CD38 and carfilzomib individually was permitted. While there are a plethora of treatment options in RRMM, KdD offers an IMiD-free treatment option in this patient population.
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Two of the three abstracts presented by Cardinal Health Specialty Solutions focused on real-world post-marketing adverse events (AEs) associated with axicabtagene ciloleucel or tisagenlecleucel, as reported in the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The first of these examined AEs associated with CAR T-cell therapy among adults age ≥65 (a population under-represented in clinical trials). The authors found that 39 percent of the AE cases reported involved patients age 65 or older. These patients had a higher incidence of neurotoxicity and atrial fibrillation, while patients age <65 had increased incidence of some CRS components, especially pyrexia and tachycardia. Younger patients also had higher rates of hospitalization. A second abstract focused on neurological AEs associated with CAR T-cell therapy. Neurological AEs were common with CAR T-cell therapy in the real world, reported in 65 percent of AE cases. The types of neurological AEs reported largely resembled those reported in clinical trials, and were associated with the agent used, age ≥65 as well as the presence of CRS, cardiac and psychiatric AEs.
A third abstract reported the perceptions of community hematologists and oncologists regarding their use of, referrals for and barriers to CAR-T therapy as well their perception of the value of the real-world CAR-T evidence, as collected during a live market research program conducted in 2019. There is significant interest in adopting and using CAR-T therapies in large B-cell lymphoma amongst community hematologists and oncologists. The top two reported barriers to prescribing/recommending CAR-T therapy were the cumbersome logistics of administering therapy and following patients (52 percent), and the cost of the therapy (46 percent). Perception of real-world CAR-T therapy evidence was favorable: 73 percent of participants indicated that this information is likely to cause them to recommend CAR-T therapy for more of their patients with diffuse large B-cell lymphoma.
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January 2020
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