Previewing Top Myeloma Abstracts Set to Make Waves at ASH 2025

With the 2025 ASH Annual Meeting set to kick off, the multiple myeloma field is bracing for another wave of data that could help inform future clinical practice decisions and research directions.

Here is a look at some of the top multiple myeloma abstracts set to make noise at ASH 2025.

LBA-6: Phase 3 randomized study of teclistamab plus daratumumab versus investigator’s choice of daratumumab and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients (Pts) with relapsed refractory multiple myeloma (RRMM): Results of MajesTEC-3

Session information: Tuesday, December 9, 7:30 AM to 9 AM EST

The phase 3 MajesTEC-3 trial (NCT05083169) evaluated the combination of teclistamab-cqyv (Tecvayli) and daratumumab and hyaluronidase-fihj (subcutaneous daratumumab; Darzalex Faspro) vs subcutaneous daratumumab plus pomalidomide and dexamethasone (DPd) or subcutaneous daratumumab plus bortezomib and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who received 1 to 3 prior lines of therapy.1 In October 2025, Johnson & Johnson announced that teclistamab plus daratumumab improved progression-free survival (PFS) and overall survival (OS) vs the control regimen.2

“The phase 3 MajesTEC-3 study that evaluated teclistamab plus daratumumab in [patients with] relapsed/refractory multiple myeloma after 1 to 3 prior lines showed a significant PFS improvement compared [with] investigator’s choice of DPd or DVd,” Yuxin Liu, MD, a physician at Dana-Farber Cancer Institute and an instructor of medicine at Harvard Medical School, told OncLive®. “This PFS and OS benefit of teclistamab plus daratumumab in relapsed/refractory multiple argues for bispecific [antibody] use in earlier lines of therapy and would be practice-changing.”

LBA-1: Minimal residual disease (MRD)-negative outcomes following a novel, in vivo gene therapy generating anti–B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells in patients with relapsed and refractory multiple myeloma (RRMM): Preliminary results from inMMyCAR, the first-in-human phase 1 study of KLN-1010

Session information: Tuesday, December 9, 7:30 AM to 9 AM EST

This presentation will feature the first data for KLN-1010, a novel in vivo gene therapy designed to produce anti-BCMA CAR T cells, as a treatment patients with relapsed and refractory multiple myeloma in the first-in-human, phase 1 inMMyCAR trial (NCT07075185).3 The presentation will include data for the first 3 patients treated with KLN-1010, who all achieved minimal residual disease (MRD) negativity at 1 month and persisted through 3 months at the longest patient follow-up.

“In these early patients, we are seeing both rapid MRD-negative responses and persistent memory-phenotype CAR T cells, a combination that has been strongly prognostic for durable clinical benefit with existing CAR T[-cell therapy] approaches,” Simon Harrison, MBBS, MRCP, FRCPath, FRACP, PhD, director of the Centre of Excellence in Cellular Immunotherapy at the Peter MacCallum Cancer Centre and lead study author, said in a press release. “Achieving these outcomes without lymphodepleting chemotherapy or CAR T-cell manufacturing underscores the potential of this in vivo approach to fundamentally expand access to CAR T[-cell] therapy for patients with relapsed and refractory multiple myeloma.”

256 - Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine—1

Session information: Saturday, December 6, 2 PM to 3:30 PM EST

Investigators will present updated findings from the phase 2 iMMagine-1 trial (NCT05396885), which evaluated anitocabtagene autoleucel (anito-cel) in patients with relapsed/refractory multiple myeloma who received at least 3 prior lines of therapy.4 Previously reported data presented at the 2025 EHA Congress showed that at a median follow-up of 12.6 months (range, 5-29), patients treated the BCMA-targeted CAR T-cell therapy (n = 117) experienced an overall response rate (ORR) of 97%, including stringent complete response (sCR)/CR rate of 68%, a very good partial response (PR) rate of 18%, and a PR rate of 12%.

“[In] the phase 2 iMMagine-1 study of anito-cel—an anti-BCMA directed CAR T-cell therapy with a novel D-domain binder—efficacy responses with anito-cel appear comparable to FDA-approved ciltacabtagene autoleucel [Carvykti],” Liu said. “[The] safety profile of anito-cel looks promising, with no reported Parkinsonism, cranial palsies, Guillain-Barré syndrome, or immune effector cell–associated enterocolitis.”

368 - Sustained minimal residual disease (sMRD) negativity in transplant ineligible newly diagnosed multiple myeloma treated with isatuximab plus lenalidomide and dexamethasone with bortezomib (Isa-VRd) versus Isa-Rd: 12-24-month data from the phase 3 benefit trial (IFM 2020-05)

Session information: Saturday, December 6, 4 PM to 5:30 PM EST

The phase 3 BENEFIT trial (NCT04751877) evaluated isatuximab plus lenalidomide and dexamethasone with or without bortezomib in patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplant.5 Previously reported findings showed that the addition of bortezomib led to improvements in 18-month MRD-negativity rate, meeting the primary end point of the study. The presentation at the 2025 ASH Annual Meeting will focus on MRD-negativity rates reported between 12 and 24 months.

372 - Daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma: Aquila outcomes based on MAYO 2018/IMWG 2020 risk stratification, IMWG 2020 plus cytogenetic criteria, and age

Session information: Saturday, December 6, 4 PM to 5:30 PM EST

In November 2025, the FDA approved subcutaneous daratumumab for the treatment of adult patients with high-risk smoldering multiple myeloma.6 The approval was based on previously reported data from the phase 3 AQUILA trial (NCT03301220), and at ASH 2025, investigators will present further data from the study, examining outcomes based on MAYO 2018 and International Myeloma Working Group 2020 criteria, along with other characteristics.

References

1. A study of teclistamab in combination with daratumumab subcutaneously (SC) (Tec-Dara) versus daratumumab SC, pomalidomide, and dexamethasone (DPd) or daratumumab SC, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (MajesTEC-3). ClinicalTrials.gov. Updated October 10, 2025. Accessed December 5, 2025. https://clinicaltrials.gov/study/NCT05083169
2. Tecvayli plus Darzalex Faspro combination regimen significantly improves progression-free survival and overall survival versus standard of care. News release. Johnson & Johnson. October 16, 2025. Accessed December 5, 2025. https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-regimen-significantly-improves-progression-free-survival-and-overall-survival-versus-standard-of-care
3. Kelonia Therapeutics announces late-breaking oral presentation of first-in-human sata from in vivo BCMA CAR-T therapy at the American Society of Hematology (ASH) 2025 Annual Meeting. News release. Kelonia Therapeutics. November 24, 2025. Accessed December 5, 2025. https://keloniatx.com/kelonia-therapeutics-announces-late-breaking-oral-presentation-of-first-in-human-data-from-in-vivo-bcma-car-t-therapy-at-the-american-society-of-hematology-ash-2025-annual-meeting/
4. Kaur G, Freeman CL, Dhakal B, et al. Phase 2 registrational study of anitocabtagene autoleucel for relapsed and/or refractory multiple myeloma (RRMM): updated results from iMMagine-1. Presented at: 2025 EHA Congress; June 12-15, 2025; Milan, Italy. Abstract S201.
5. Leleu X, Hulin C, Lambert J, et al. Isatuximab, lenalidomide, dexamethasone and bortezomib in transplant-ineligible multiple myeloma: the randomized phase 3 BENEFIT trial. Nat Med. 2024;30(8):2235-2241. doi:10.1038/s41591-024-03050-2
6. FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma. FDA. November 6, 2025. Accessed November 6, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma