Johnson & Johnson (J&J) has unveiled first-in-human data on its trispecific antibody that demonstrates a 100% response rate in a small group of patients with relapsed or refractory multiple myeloma (r/r MM).
The initial data from the Phase I trial (NCT05652335) of JNJ-5322 shows that the trispecific antibody led to a 100% overall response rate (ORR) in 27 patients who were na茂ve to anti-BCMA/-GPRC5D therapies at a median follow-up of 8.2 months. The patients were treated with the proposed Phase II dose of 100mg four times weekly (Q4W).
JNJ-5322 simultaneously targets BCMA (B-cell maturation antigen), GPRC5D (G protein coupled receptor family C group 5 member D), and CD3 (cluster of differentiation 3). The drug engages both malignant B cells and T cells, inducing anti-cancer cytotoxicity and T-cell activation, while overcoming tumour heterogeneity.
All responders remain in response as of a median 8.5 month follow-up, with a median time to first response of 1.2 months.
The Phase I trial, initiated in November 2022, has enrolled 126 patients as of 15 January 2025 with r/r MM previously exposed to proteosome inhibitors, immunomodulatory drugs, and anti-CD3 monoclonal antibodies (mAb). After dose escalation, 36 patients were administered 100mg JNJ-5322 subcutaneously Q4W as the putative recommended Phase II dose. The data was presented at the 2025 American Society of Clinical Oncology (ASCO) conference held in Chicago, Illinois, on 3 June.
However, 99% of the collective cohort experienced at least one adverse event (AE), most commonly cytokine release syndrome (59%), while 75% reported infection. In the case of five patients, toxicities proved dose-limiting, and four patients died as a result of AEs.
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By GlobalDataJ&J鈥檚 candidate was granted an orphan drug status to treat r/r MM by the US Food and Drug Administration (FDA) on 27 November 2024. The data presented at ASCO 2025 represent the first clinical insight into the drug鈥檚 potential. Abstract authors stated, 鈥渇irst data with JN-5322 suggest a paradigm shift, offering ORRs similar to CAR-Ts (chimeric antigen receptor-Ts) but as an off-the-shelf therapy.鈥�
JN-5322 is developed using J&J鈥檚 antibody discovery platform OmniAb technology. J&J licenced the technology to develop antibodies for multiple myeloma through a partnership with OmniAb鈥檚 parent company Ligand 色界吧s, which was spun out from Ligand in 2022.
