Session: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Hematology Disease Topics & Pathways:
Research, clinical trials, adult, Biological therapies, Lymphomas, non-Hodgkin lymphoma, Clinical Research, B Cell lymphoma, Chimeric Antigen Receptor (CAR)-T Cell Therapies, Diseases, Therapies, Lymphoid Malignancies, Study Population, Human
Methods: The study enrolled patients with confirmed diagnosis of MCL, relapsed or refractory after at least 2 lines of prior therapies including anti-CD20 antibody, anthracycline or bendamustine, and BTKi. After lymphodepleting chemotherapy, patients received relma-cel (100×106 CAR+ T cells). Bridging therapy was allowed. Primary endpoint was ORR at month 3 assessed by investigator, and secondary endpoints included complete response rate (CRR) at month 3, duration of response (DoR), progression-free survival (PFS), OS, pharmacokinetics (PK), pharmacodynamics (PD) and safety.
Results: As of June 30, 2023, 66 patients enrolled and received leukapheresis. Relma-cel was administered in 56 patients (78.6% males; median age of 59.5 years). 42 patients had tumor assessment at month 3 or discontinued treatment due to death, disease progression before evaluation. The study population had poor prognostic factors at baseline:
- Age: 19 (33.9%) ≥ 65 years old
- Pathology: 13 (23.2%) with blastoid and 6 (10.7%) with pleomorphic variants
- 30 (53.6%) with extranodal lesions, 4 (7.1%) with gastrointestinal involvement; 28 (50.0%) with spleen involvement, 17 (30.4%) with bone marrow involvement
- MCL International Prognostic Index (MIPI) score ≥ 4: 27 (48.2%)
- High tumor burden: 17 (30.4%) had bulky disease ≥ 5 cm
Over 65% patients received ≥ 3 lines of prior therapies, including 25.0% patients received ≥ 5 lines. Almost all patients failed to BTKi (29 [51.8%] relapsed and 25 [44.6%] refractory). Seven (12.5%) patients relapsed after hematopoietic stem cell transplantation (HSCT). Twenty-six (46.4%) patients underwent bridging therapy.
At month 3, of the 42 efficacy-assessable patients, 27 (64.29%) reached objective responses (OR), and 23 (54. 76%) achieved complete response (CR). Best ORR was 78.57% and best CRR was 66.67%.
Based on the safety analysis set of 56 patients, 52 (92.86%) patients had treatment emergent adverse events (TEAE), including 44 (78.57%) with treatment related TEAE of grade ≥ 3. Twenty-five (44.64%) patients had serious adverse events (SAE), and 13 (23.21%) with treatment related SAE. Thirty-one (55.36%) patients had cytokine release syndrome (CRS), 3 (5.36%) with grade ≥ 3. Six (10.71%) patients had neurotoxicities (NT), 4 (7.14%) with grade ≥ 3. Twenty-seven (48.21%) patients had infections, 15 (26.79%) with grade ≥ 3. Forty-seven (83.93%) patients had prolonged cytopenia, 38 (67.86%) with grade ≥ 3. Eighteen (32.1%) deaths occurred, 6 (10.7%) died from disease progression, 8 (14.3%) due to AE, 2 (3.6%) died from treatment related AE, 4 (7.2%) from other reasons or unknown causes.
Conclusions: In this phase II study, relma-cel continually demonstrated high response rates (best ORR: 78.57%; best CRR: 66.67%) and good tolerability in patients with r/r MCL.
Disclosures: Qin: JW therapeutics(Shanghai) Co., Ltd: Current Employment, Current holder of stock options in a privately-held company. Xia: JW therapeutics(Shanghai) Co., Ltd: Current Employment, Current holder of stock options in a privately-held company. Gu: JW therapeutics(Shanghai) Co., Ltd: Current Employment, Current holder of stock options in a privately-held company. Zhou: JW therapeutics(Shanghai) Co., Ltd: Current Employment, Current holder of stock options in a privately-held company. Tian: JW therapeutics(Shanghai) Co., Ltd: Current Employment, Current holder of stock options in a privately-held company.