News|Events|May 26, 2026

Late-Stage CAR-T, Bispecific Therapies Drive Transformation in the Multiple Myeloma Pipeline

Listen
0:00 / 0:00

A new DelveInsight pipeline report highlights how late-stage CAR-T and bispecific antibody therapies are driving the next wave of innovation in multiple myeloma, with several BCMA-targeted biologics advancing toward potential regulatory milestones. The report underscores growing industry focus on earlier-line immunotherapy use, durable responses, and evolving treatment sequencing strategies in relapsed and refractory disease.

The multiple myeloma pipeline continues shifting toward immunotherapy-driven treatment strategies as developers advance next-generation CAR-T therapies and bispecific antibodies into later-stage clinical development. A recent DelveInsight report identified seven late-stage therapies that could significantly influence future treatment paradigms in relapsed and refractory multiple myeloma (RRMM).¹

The report reflects broader momentum across the hematologic oncology market, where BCMA-targeted therapies are increasingly moving into earlier lines of treatment following strong clinical activity in heavily pretreated patients.³˒⁴ Multiple myeloma remains incurable despite major advances in proteasome inhibitors, immunomodulatory drugs, monoclonal antibodies, and cellular therapies, leaving continued unmet need around relapse prevention, resistance, and durability of response.²

What is anito-cel and why is it important in relapsed or refractory multiple myeloma?

Among the most closely watched candidates is anitocabtagene autoleucel (anito-cel), a BCMA-directed CAR-T therapy being developed by Arcellx and Gilead’s Kite Pharma. According to the report, anito-cel is currently being evaluated in the confirmatory Phase 3 iMMagine-3 trial in second-line and later RRMM as well as the pivotal Phase 2 iMMagine-1 study in heavily pretreated patients.¹

The therapy uses a proprietary D-domain BCMA binder designed to support rapid and transient target interaction while potentially improving safety compared with earlier CAR-T approaches. The companies are also preparing to initiate the Phase 3 iMMagine-4 study in newly diagnosed multiple myeloma following supportive safety findings from the GEM-AnitoFIRST study.¹

How could AbbVie’s ABBV-383 bispecific antibody affect the BCMA therapy market?

The report additionally highlighted AbbVie’s BCMA-directed bispecific antibody ABBV-383, also known as etentamig, which is currently in Phase 3 evaluation for RRMM.¹ The IgG4 bispecific antibody is engineered with a low-activating CD3 domain intended to selectively engage effector T cells while limiting excessive cytokine-mediated activation.

Bispecific antibodies and CAR-T therapies have become increasingly important in multiple myeloma because they offer targeted immune-mediated killing of malignant plasma cells while potentially producing deeper and more durable responses than conventional therapies.²˒³ However, clinical questions remain regarding sequencing, long-term tolerability, manufacturing scalability, and accessibility.

Why are BCMA-targeted biologics becoming central to multiple myeloma treatment strategies?

Commercial competition in the category is also intensifying. DelveInsight noted that CARVYKTI has already become one of the strongest CAR-T launches in multiple myeloma, with utilization increasingly shifting into earlier-line treatment settings.¹ The report also identified continued frontline dominance for anti-CD38 therapies such as daratumumab.²

The report reflects broader momentum across the hematologic oncology market, where BCMA-targeted therapies are increasingly moving into earlier lines of treatment following strong clinical activity in heavily pretreated patients

As next-generation BCMA-targeted biologics continue advancing through registrational studies, the multiple myeloma market is expected to become increasingly defined by immunotherapy combinations, earlier intervention strategies, and personalized treatment sequencing.¹˒⁴

References

  1. Emerging Hope in Multiple Myeloma Market: 7 Late-Stage Therapies Nearing the Finish Line. (2026 May 25). DelveInsight. https://www.delveinsight.com/report-store/multiple-myeloma-pipeline-insight
  2. Multiple Myeloma Treatment (PDQ®)–Health Professional Version. (2025 Apr 25). US National Cancer Institute. https://www.cancer.gov/types/myeloma/hp/myeloma-treatment-pdq
  3. Munshi NC, Anderson LD Jr, Shah N, et al. (2021 Feb 25). Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med. https://pubmed.ncbi.nlm.nih.gov/33626253/
  4. Niels W C J van de Donk, Saad Z Usmani, Kwee Yong. (2021 Jun). CAR T-cell therapy for multiple myeloma: state of the art and prospects. The Lancet Haematology. https://doi.org/10.1016/S2352-3026(21)00057-0.