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.