Clinical Lymphoma, Myeloma & Leukemia, Vol.22, Suppl.2 - October 2022

Abstracts Clinical Lymphoma, Myeloma & Leukemia October 2022 S408 in carfilzomib trials clustered into groups with known risk factors. Characteristics associated with cardiovascular AEs were detectable by standard clinical assessment or laboratory tests. Study limitations include the lack of comparator arm, small number of Asian patients (n=102), and that this novel methodology has not been validated in clinical settings. These findings suggest that topological analysis may be a useful tool for leveraging machine learning in clinical trials. Keywords: MM, multiple myeloma, topological analysis, machine learning MM-149 Impact of Early Relapse on Survival of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation Federico Cataldo MD, Cristian Seehaus MD, Erika Brulc MD, Jorge Arbelbide MD, Dorotea Fantl MD, Natalia Schutz MD Hospital Italiano, Buenos Aires, Argentina Backgrou n d: The survival of patients with multiple myeloma (MM) has improved in recent years due to the combination of new treatments together with autologous stem cell transplantation (ASCT) and maintenance therapy. Early relapse (ER) has been identified as an independent risk factor for shorter overall survival (OS) having even a greater impact than high-risk cytogenetic alterations. Objecti v es: Evaluate OS of patients with ER and review the factors associated. D esig n : Retrospective, observational and single-center study that included patients with MM who received bortezomib-based induction therapy and ASCT from 2010 to 2020. ER was considered as relapse or progression within 12 months after ASCT. Results: We included a total of 200 patients comparing the group with ER vs the non-ER patients (NER). The most common induction treatment used was CyBorD in the ER group 23 ( 7 4%) vs. 124 ( 7 4%) in NER patients; followed by VTD and RVD. From the entire cohort 104 (52%) patients received maintenance, the 7 1% with lenalidomide. Complete response post-transplantation was achieved in 103 (51%) patients. After a median follow-up of 3 7 .5 months (IQR; 15-6 7 ), the median PFS was 48 months (95% CI; 40- 60). A total of 31 patients (16%) presented ER, with a median relapse time of 7 months (95% CI; 4-9). These patients had more frequently ISS III (48% vs 32%, p<0.05) and partial response to treatment (29% vs 15%, p 0.06) with less frequent maintenance therapy (32% vs 56%, p<0.01). The OS at 5 years for patients with ER was 22% with a median of 21 months; vs 86% at the same time in the NER group with a median not reached. ER was one of the most important prognostic factors for decreased survival after ASCT (hazard ratio, 9.26, p<0.001), even adjusting for cytogenetic risk. Co n clusio n s: ER represents a poor prognosis even with new treatment options and beyond cytogenetic risk. Identifying prognostic factors associated with ER could be useful for performing a risk-adapted treatment. In addition, these groups of patients should be incorporated into clinical trials with the purpose of identifying useful and novel rescue treatments in the future. Keywords: MM, multiple myeloma, early relapse, stem cell transplant, prognostic factors MM-153 Phase 2 CARTITUDE-2 Study (Cohort B): Updated Clinical Data and Biological Correlative Analyses of Ciltacabtagene Autoleucel (cilta-cel), a BCMA-Directed CAR-T Cell Therapy, in Patients With Multiple Myeloma (MM) and Early Relapse After Initial Therapy Mounzer Agha MD 1 , Niels WCJ van de Donk MD, PhD 2 , Adam D Cohen MD 3 , Yael C Cohen MD 4 , Sébastien Anguille MD 5 , Tessa Kerre MD, PhD 6 , Wilfried Roeloffzen MD 7 , Jordan M Schecter MD 8 , Kevin C De Braganca MD 8 , Helen Varsos MS, RPh 8 , Pankaj Mistry PhD 9 , Tito Roccia MD 9 , Enrique Zudaire PhD 10 , Christina Corsale CCRP 8 , Muhammed Akram MD 11 , Dong Geng PhD 11 , Tonia Nesheiwat PharmD 11 , Lida Pacaud MD 11 , Pieter Sonneveld MD, PhD 12 , Sonja Zweegman MD, PhD 2 1 UPMC Hillman Cancer Center, Pittsburgh, PA, USA. 2 Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. 3 Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. 4 Tel-Aviv Sourasky (Ichilov) Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. 5 Vaccine and Infectious Disease Institute, University of Antwerp, Edegem, Belgium, Center for Cell Therapy and Regenerative Medicine, Antwerp University Hospital, Edegem, Belgium. 6 University Hospital Ghent, Ghent, Belgium. 7 University Medical Center Groningen, Groningen, Netherlands. 8 Janssen Research & Development, Raritan, NJ, USA. 9 Janssen Research & Development, High Wycombe, United Kingdom. 10 Janssen Research & Development, Spring House, PA, USA. 11 Legend Biotech USA, Piscataway, NJ, USA. 12 Erasmus MC University and Medical Center, Rotterdam, Netherlands Co n text: CARTITUDE-2 (NCT04133636) Cohort B is evaluating cilta-cel in patients with MM and early relapse after initial therapy. These patients have functionally high-risk disease and unmet medical needs, as early relapse post-ASCT is associated with a poor prognosis. Objecti v e: To present updated results from CARTITUDE-2 Cohort B. D esig n : Phase 2, multicohort study. Patie n ts: Eligible patients had MM, 1 prior LOT (PI and IMiD required), disease progression per IMWG, and no previous treatment with CAR-T/anti-BCMA therapies. I n ter v e n tio n : Single cilta-cel infusion (target dose 0. 7 5×10 6 CAR+ viable T-cells/ kg) post lymphodepletion. Mai n Outco m e Measures: Safety and efficacy were evaluated. Primary endpoint was MRD negativity at 10 -5 . Management strategies were used to reduce the risk of movement/neurocognitive AEs (MNTs). Assessments included pharmacokinetics (PK) (C max , T max of CAR+ T-cell transgene levels in blood), CRS-related cytokine (eg, IL-6) levels over time, peak cytokine levels by response and CRS, association of cytokine levels with ICANS, and CAR+ T-cell CD4/CD8 ratio by response, CRS, and ICANS. Results: As of January 2022 (median follow-up 13.4 months), 19 patients (median age 58.0 years; 7 4% male; 7 9% with