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3588 Clinical Outcome of Patients with Relapsed Refractory Multiple Myeloma Listed for BCMA Directed Commercial CAR T Therapy

Program: Oral and Poster Abstracts
Session: 905. Outcomes Research—Lymphoid Malignancies: Poster II
Hematology Disease Topics & Pathways:
adult, Clinical Practice (Health Services and Quality), Plasma Cell Disorders, Diseases, Lymphoid Malignancies, Study Population, Human
Sunday, December 11, 2022, 6:00 PM-8:00 PM

Samer Al Hadidi, MD, MSc1, Aniko Szabo, PhD2*, Jean Esselmann3*, Lindsay Hammons, MD4, Munawwar Hussain, MD5*, Yetunde Ogunsesan, MD5*, Nishanth Thalambedu, MD6*, Fatima Khan6*, Jaskirat Sethi, MD5*, Abhishek Janardan3*, Sabarinath Radhakrishnan7*, Sharmilan Thanendrarajan, MD1, Carolina Schinke1, Binod Dhakal, MBBS8, Siegfried Janz9, Saurabh Chhabra, MD, MS10, Anita D'Souza, MD, MS11, Maurizio Zangari, MD1, Frits van Rhee5 and Meera Mohan, MD12

1Myeloma Center, Winthrop P. Rockefeller Institute, Department of Internal Medicine, University of Arkansas for Medical Sciences, Little Rock, AR
2Division of Biostatistics, Institute of Health & Equity, Medical College of Wisconsin, Milwaukee, WI
3Bone Marrow Transplant Service, Division of Hematology Oncology, Medical College of Wisconsin, Milwaukee, WI
4Hematology/Oncology, Medical College of Wisconsin, Milwaukee, WI
5Myeloma Center, University of Arkansas for Medical Sciences, Little Rock, AR
6Myeloma Center, Division of Hematology Oncology, University of Arkansas for Medical Sciences, Little Rock, AR
7Medical college of Wisconsin, Milwaukee, WI
8Medical College of Wisconsin, Division of Hematology/Oncology, Department of Medicine, Milwaukee, WI
9Division of Hematology Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
10Division of Hematology/Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
11Center for International Blood and Marrow Transplant Research, Department of Medicine, The Medical College of Wisconsin Inc., Milwaukee, WI
12Medical College of Wisconsin, Milwaukee, WI

Introduction

B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy was recently approved for use in relapsed/refractory multiple myeloma (RRMM). High response rates were reported with CAR-T therapy in clinical trials and from limited real-world experiences. Currently, patients eligible for commercial CAR-T therapy are heavily pre-treated with limited therapy options. The application of commercial CAR-T therapy in RRMM is marred by several issues most importantly, access to therapy. We sought to investigate the real-world experience of outcomes of patients with RRMM on commercial CAR-T wait list since its approval in March 2021.

Methods

All patients on commercial CAR-T waiting list at the University of Arkansas for Medical Sciences and Medical College of Wisconsin were included. We limited our data to the patients listed for idecabtagene vicleucel (ide-cel/ABECMA®). Clinical data was retrospectively collected with data cut off set on March 31, 2022.The cumulative incidence of CAR-T related events of interest, death, and removal from the list for other reasons over time was estimated using the Nelson-Aalen estimator. Patients who did not experience any of these events were censored at last follow-up.

Results

A total of 81 patients were added to the commercial CAR-T list between March 2021 and March 2022. The median age was 62 (range, 27-84) years with 52% being female. Ten patients (12%) were Black and 15% were out of state residents. The prior lines of therapy were 6 (2-10) and median time from diagnosis to listing for CAR-T therapy was 4.5 (range 0.8 -17.5) years. Nearly 93% patient received prior autologous stem cell transplantation (SCT) and 12% prior allogenic SCT for MM. About 90% (n=73) patients met the International Myeloma Working Group definition of progressive disease at the time of CAR-T listing. The majority (69%, n=56) of patients suffered disease relapse while waiting for apheresis. The median line of therapies after listing for patients who underwent apheresis and or received CAR T infusion was 1 (0-3). The cumulative incidence of receiving CAR-T therapy at 3-, 6- and 12-months time points were 1.34% (95% CI 0.19-9.37), 15.4% (95% CI 8.66-27.2), and 28.9% (95% CI 18.7-44.6), respectively (figure 1). The cumulative incidence of death at 12 months, while waiting for CAR-T was 31.9% (95% CI 20.5-49.5). While 12% of patients were removed, 27% remain waiting for CAR-T therapy at 12 months. The decision to remove from CAR-T listing was at the physician’s discretion and included enrollment in clinical trials, procurement of CAR-T slots at an alternative center, concerns of toxicity, and diagnosis of incidental myelodysplastic disease. A total of 23 patients underwent apheresis, of which 19 were able to successfully receive CAR-T therapy. The median time to apheresis and CAR-T therapy from listing were 3.6 (range 0.9-10.3) months and 5.1 ( 2.5-9.8) months, respectively. Three patients died waiting for CAR-T manufacturing after successful apheresis and one patient is still waiting for infusion as of last follow up. Failed attempt at apheresis occurred in one patient and failed CAR-T manufacturing after successful apheresis occurred in one patient in this series.

Conclusions

Among heavily pretreated RRMM patients listed for commercial BCMA CAR-T therapy, the cumulative incidence of receiving CAR-T therapy at 12 months was low at 29%. About a third of patients died waiting for CAR-T therapy in our analysis. Despite the effectiveness of CAR-T therapy in heavily pretreated MM patients in clinical trials, a limited number of patients were able to receive it in the real-world setting.

Disclosures: Schinke: Janssen: Honoraria. Dhakal: Karyopharm Therapeutics: Honoraria, Speakers Bureau; Sanofi: Consultancy, Honoraria, Research Funding, Speakers Bureau; GlaxoSmithKline: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Natera: Consultancy; BMS: Honoraria, Research Funding; Arcellx: Research Funding; Carsgen: Research Funding; Cartesian: Research Funding; Fate: Research Funding; Takeda: Honoraria; Pfizer: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Genentech: Membership on an entity's Board of Directors or advisory committees. Chhabra: Amgen: Research Funding; GlaxoSmithKline: Honoraria; Janssen: Research Funding; Sanofi: Research Funding. D'Souza: Pfizer, Janssen Oncology, Bristol Myers Squibb/Celgene, Prothena: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda, Sanofi, TeneoBio, Prothena, Caelum Biosciences, Janssen Oncology, Regeneron, AbbVie: Research Funding. van Rhee: Takeda: Consultancy; GlaxoSmithKline: Consultancy; Karyopharm: Consultancy; EUSA Pharma: Consultancy; Janssen Pharmaceuticals: Research Funding; Bristol Myers Squibb: Research Funding. Mohan: Novartis: Research Funding; BMS/Celgene: Research Funding; GSK: Research Funding; Takeda: Research Funding.

*signifies non-member of ASH