Roswell Park Experts Present Latest Discoveries in Stem Cell Transplantation, Cellular Therapy

February 21, 2024

Hillengass headlines podium presentation at 2024 Tandem Meetings in San Antonio

Data updated on CARTITUDE-2 clinical trial for multiple myeloma
Given earlier, ciltacabtagene autoleucel produced deep, durable responses
Even after early relapse, high-risk patients experienced durable efficacy

BUFFALO, N.Y. — The Chief of Myeloma at Roswell Park Comprehensive Cancer Center will deliver the latest findings of the CARTITUDE-2 clinical trial at the 2024 Tandem Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and Center for International Blood and Marrow Transplant Research (CIBMTR), running Feb. 21-24 in San Antonio, Texas.

Jens Hillengass, MD, PhD, who also serves as Vice Chair for Research at Roswell Park, will present a podium talk highlighting updated data from the phase 2 trial (NCT04133636), which demonstrated that a single infusion of the CAR T-cell therapy ciltacabtagene autoleucel (cilta-cel; brand name Carvykti) resulted in deep, durable responses in multiple myeloma patients whose disease had progressed less than a year after autologous stem cell transplant (ASCT) or who experienced relapse after receiving up to three lines of initial therapy.

Cilta-cel is a chimeric antigen receptor (CAR) T-cell therapy that engineers the patient’s own T cells to target the B-cell maturation antigen (BCMA), which is expressed on multiple myeloma cells but not on most other cells. The FDA approved cilta-cel in 2022 for treating patients with relapsed or refractory multiple myeloma who previously had received at least four lines of therapy.

The clinical trial, designed to evaluate the safety and efficacy of cilta-cel, opened in November 2019 with 169 multiple myeloma patients who were assigned to eight different cohorts with different characteristics. Dr. Hillengass will report the updated data, collected in April 2023, for 20 patients in Cohort A, who had received between one and three prior lines of therapy, and 19 patients in Cohort B, who had relapsed a year or less after either ASCT or the start of initial anti-myeloma treatment if they did not undergo ASCT. Data on the two cohorts were reported previously at 17 and 18 months, respectively.

At a median follow-up of 29.9 months, a highly sensitive test on bone marrow samples revealed that 17 patients from Cohort A were MRD (minimal residual disease)-evaluable, and all achieved MRD negativity, with no residual cancer cells detected with a sensitivity of 1 in 100,000 cells. At a median follow-up of 27.9 months, 15 patients in Cohort B were MRD-evaluable, and 14 (93%) achieved MRD negativity.

Cohort A experienced overall response rates of 95% (complete response or better, 90%); Cohort B achieved 100% overall response rates (complete response or better, 89.5%). Median progression-free survival was not reached in either cohort, and 24-month progression-free survival rates were 75% in Cohort A and 73% in Cohort B.

“We’re very excited to see how well CAR T cells work in earlier lines of therapy, because we think the T cells used to manufacture the CAR T cells are less exhausted when they are collected in earlier lines compared to late lines of therapy,” says Dr. Hillengass. He adds that the treatment was well tolerated in both cohorts, with the usual expected side effects of cytokine release syndrome, immune-cell-associated neurotoxicity and hematologic toxicity.

Dr. Hillengass was first author of the updated study, which was co-authored by investigators representing institutions in eight countries. With a goal of deepening patients’ response to therapy and improving survival outcomes, he and his colleagues continue to evaluate the potential of anti-BCMA CAR T-cell therapy administered in earlier lines of therapy. Roswell Park participates in the phase 2, multicenter BMTCTN 1902 clinical trial (NCT05032820) that is evaluating bb2121 anti-BCMA CAR T-cell therapy in patients who have had a suboptimal response after ASCT and three months of maintenance therapy.

(#42) Presentation Details: “The Phase 2 Cartitude-2 Trial: Updated Efficacy and Safety of Ciltacabtagene Autoleucel in Patients with Multiple Myeloma and 1-3 Prior Lines of Therapy (Cohort A) and with Early Relapse after First Line Treatment (Cohort B)”: Thursday, Feb. 22, 4:30-4:45 p.m., CST, Stars at Night B4 (Ballroom Level).

Betts co-chairs CIBMTR Immunobiology Working Committee

Brian Betts, MD, Professor of Oncology in the Department of Medicine - Transplant & Cellular Therapy and Vice Chair of Strategic Initiatives, will moderate the CIBMTR Immunobiology Working Committee, of which he is co-chair: Thursday, Feb. 22, 1-3 p.m., CST, in 303AB (Ballroom Level).

Six poster sessions presented Feb. 22

Roswell Park experts also co-authored posters that will be presented Thursday, Feb. 22, in the Henry B. González Convention Center:

(#39) Marco Davila, MD, PhD, Senior Vice President and Associate Director for Translational Research, is co-author of a poster on immune engager therapies in multiple myeloma: 3:45-4 p.m., CST, at Stars at Night B4 (Ballroom Level).
(#118) Theresa Hahn, PhD, Professor of Oncology, Department of Cancer Prevention and Control, is senior/presenting author of a poster describing an inherited variant linked to risk of secondary acute lymphoblastic leukemia in multiple myeloma patients: 6:45-7:45 p.m., CST, Exhibit Hall 4a (Street Level).
(#361) Shernan Holtan, MD, Chief of Blood and Marrow Transplant, is first and presenting author of a poster describing the results of work she conducted while at the University of Minnesota, on Aurora kinase A inhibition for graft-versus-host disease and prevention of relapse after allogeneic hematopoietic stem cell transplantation: 6:45-7:45 p.m., CST, Exhibit Hall 4a (Street Level). Betts is senior author of the poster.
(#339) Betts served as senior author of a poster for which Drs. Davila and Holtan were co-authors, sharing results of a phase 3 clinical trial evaluating JAK2/mTOR inhibition as a means of preventing acute graft-versus-host disease: 6:45-7:45 p.m., CST, Exhibit Hall 4a (Street Level).
(#564) Hematology/Oncology Fellow Fellow Muhammad Salman Faisal, MD, MBBS, is presenting author of a poster focusing on predictors of outcomes in older patients with myelofibrosis: 6:45-7:45 p.m., CST, Exhibit Hall 4a (Street Level).
(#153) Hematology/Oncology Fellow Matthew Gravina, MD, is presenting author of a poster on tocilizumab for prevention of cytokine release syndrome in haploidentical peripheral stem cell transplantation: 6:45-7:45 p.m., CST, Exhibit Hall 4a (Street Level).

The Tandem Meetings promote the exchange of information about the latest advances in hematopoietic cell transplantation and cellular therapy for blood-related cancers, with the aim of extending patient survival and improving quality of life.