CAR T-cell therapies: Measuring the growing need for increasing long-term safety protocols.

person Yacoub Faroun St. Luke's Cancer Care Associates, Fountain Hill, PA info_outline Yacoub Faroun, Daniel F. Winkelman, Nicholas Gambone, Patrick Angelastro

Authors person Yacoub Faroun St. Luke's Cancer Care Associates, Fountain Hill, PA info_outline Yacoub Faroun, Daniel F. Winkelman, Nicholas Gambone, Patrick Angelastro Organizations St. Luke's Cancer Care Associates, Fountain Hill, PA, IQVIA, Wayne, PA Abstract Disclosures Research Funding No funding sources reported Background: The CAR T-Cell market has grown significantly over the last five years with six products in the U.S. market covering a range of cancer types (DLBCL, FL, MCL, MM, ALL). The number of transplant centers certified for CAR T-Cell administration has also grown from 142 centers in Q4 2020 to 200 in Q4 2023. The FDA is currently investigating the safety of CAR T-Cell therapies due to the threat of secondary malignancies. CAR T-Cell patients are treated at advanced treatment centers but after they have completed therapy, they are often referred back to their original specialist for long-term monitoring. The purpose of this research is to measure if referring Oncologists have the information required to safely manage CAR T-Cell patients. Methods: This study followed market research best practices. The study was based on a survey of the BrandImpact panel of Oncologists who refer patients and a CAR T-Cell Panel of Oncologists who administer CAR T-Cell therapies. Results: The majority of referring Oncologists (61%) report they could use more information about CAR T-Cell therapies. When asked on an unaided basis what type of information they require, the most common request was for additional safety information (57%). At the same time, one-third of Oncologists treating CAR T-Cell patients at the advanced centers feel that there needs to be improved knowledge of the long-term safety aspects of CAR T-Cell therapies. When they resume monitoring CAR T-Cell patients, they would like to better understand the relevant long-term side effects and how they differ from the short-term side effects. Conclusions: Oncologists who refer CAR T-Cell patients report that they need more information; mainly around safety/side-effects. Of the Oncologists administering CAR T-Cell therapies, one-third feel there needs to be improved knowledge of the long-term safety issues. Consideration should be given to improving the level of educational information provided on this topic to improve CAR T-Cell patient outcomes. CAR T-Cell Referring Oncologists (n = 100) Level of information received about CAR T-Cell Therapy (% of Oncologists) I need a lot more information 12% I could use more information 49% I know as much as I need to know 29% Extremely well informed 10% CAR T-Cell Referring Oncologists (n = 100) Type of information needed to confidently manage CAR T-Cell Patients (unaided responses > 100%) Safety/Side effects 57% Efficacy 21% Additional Data 12% Indications/Patient types 10% Administration 10% Logistics 7% CAR T-Cell Treating Oncologists (n = 50) What improvements are needed on the referring side? Improved knowledge of the long-term safety aspects of CAR T-Cell therapies (e.g., secondary malignancies) 33%