Idecabtagene Vicleucel (ide-cel, bb2121), a BCMA-Directed CAR T Cell Therapy: Qualitative Analyses of Early Post-Treatment Interviews With Relapsed and Refractory Multiple Myeloma (RRMM) Patients in the KarMMa Clinical Trial
Author(s)
Braverman J1, Dhanda D1, Moshkovich O2, Lanar S3, Miera M2, Williams AE4, Murphy R2, Devlen J5, Hege K1, Campbell TB1
1Bristol-Myers Squibb, Princeton, NJ, USA, 2ICON, Gaithersburg, MD, USA, 3ICON plc, Lyon, France, 4ICON plc, London, UK, 5ICON, Shippensburg, PA, USA
OBJECTIVES: Ide-cel, a BCMA-directed CAR T cell therapy, showed deep, durable responses in heavily pretreated, triple-class exposed RRMM patients in the ongoing, multicenter, single-arm, pivotal phase 2 KarMMa clinical trial (NCT03361748) (Munshi NC, et al. J Clin Oncol 2020;38:8503). We aimed to understand the patient treatment experience, perceived advantages and disadvantages of ide-cel treatment, and health-related quality of life following ide-cel treatment. METHODS: To assess patient experience beyond standard patient-reported outcomes, ide-cel-treated patients in the KarMMa trial were provided with the option to participate in a series of interviews. We present results of monthly interviews from the first 3 months post ide-cel infusion. The analysis included thematic analysis, quantitative descriptive analysis of close-ended items, and longitudinal analysis. RESULTS: Of 128 patients treated with ide-cel, 58 (45%) patients from the United States and Europe consented and participated in interviews. Most patients (85%) reported a positive treatment experience with ide-cel. Fatigue (22%) was the longest-lasting symptom, which typically resolved within 1 month post-infusion. Compared with other treatments, patients reported more advantages than disadvantages for ide-cel. Most frequently reported advantages were treatment efficacy (53%) and no maintenance therapy (61%), whereas the most frequently reported disadvantages were hypothetical (75%) and related to uncertainty in future outcomes. Overall, 50% of patients who discussed comparisons between ide-cel treatment and stem cell transplantation reported they were similar. Most patients (>64%) reported benefits of ide-cel treatment outweighed negatives and >85% would choose ide-cel treatment if they had to make the same decision regarding their course of therapy. Improvement in physical well-being was reported by 62% of patients by month 3 post-infusion. CONCLUSIONS: Most patients who were interviewed reported a positive treatment experience with ide-cel, viewed ide-cel as more tolerable than other therapies, and reported that if they had to make the decision again, they would still choose ide-cel treatment.
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Code
PCN221
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Drugs, Oncology