Johnson & Johnson Unlocks a Key Strategy to Mitigate CRS Risk in TCE Bispecific Antibody Therapy

TCE bispecific antibodies have not only achieved success in hematological tumors but also made breakthroughs in solid tumor treatment. However, for TCE therapy, CRS has always been a significant safety concern. Various solutions have already been applied in clinical practice to address this issue, such as utilizing...Step-up dose or utilizationIL-6R Antibody tOcilizumab is used for the treatment of CRS, but these regimens cannot inherently reduce the incidence of CRS. At this year's EHA conference, Johnson & Johnson presented a potential solution:tOcilizumab pre-administration significantly reduces the incidence of CRS without compromising efficacy, making it possible for patients to receive treatment in an outpatient setting (without hospitalization).

InTalquetamabIn the MonumenTAL-1 clinical prior study, 73%-79% of patients experienced CRS reactions, with 35%-47% of patients receivingtOcilizumab Treatment. This clinical study comes fromPhase II Clinical Study of MonumenTAL-1.

In terms of CRS occurrence, among the 402 patients in the MonumenTAL-1 clinical trial, the overall incidence of CRS was 72.4%, with the majority being Grade 1 reactions. Grade 2 CRS reactions occurred in 15.7% of patients, and Grade 3 reactions occurred in 1.2% of patients. In patients pretreated with tocilizumab, the overall incidence of CRS was 18.5%, all of which were Grade 1 reactions, significantly lower than in previous clinical studies.

In patients who received early treatment with tocilizumab, whether hospitalized or treated in an outpatient clinic, the overall incidence of CRS was relatively low, 30% vs 11.8%, and all cases were grade 1 CRS reactions.

In terms of other side effects, hematological toxicity mainly includes neutropenia, anemia, and lymphocytopenia. Non-hematological toxicity primarily involves side effects related to taste, skin, weight, dry mouth, and nails. Other side effects mainly include infections and ICANS.

In terms of efficacy, Overall, the ORR of early treatment with tocilizumab is comparable to the clinical efficacy of MonumenTAL-1:81.8% VS 72.7%, in terms of complete remission ≥CR, the early treatment group was 63.6%, while the MonumenTAL-1 clinical treatment group was 39.5%., In terms of ≥VGPR, the two groups were 81.8% vs 60.5%, respectively. Overall, earlier treatment with tocilizumab showed better efficacy, but the number of patients is still relatively small at this stage. The final efficacy will depend on subsequent clinical data. However, based on current data, earlier treatment with tocilizumab does not appear to negatively impact its efficacy.

In terms of mood, physical condition, and GHS (Global Health Status)Compared with the start of treatment (BL: Baseline), early treatment with tocilizumab did not worsen overall, and the severity of the disease gradually decreased as the treatment progressed.

Summary

Early administration of tocilizumab in maintenanceWhile talquetamab is effective,Will not increaseTalquetamab ICANS and target-related side effects, but it can significantly reduce the incidence of CRS. In fact, many articles have already shown that TCE bispecific antibody therapy and CRS side effects can be decoupled, meaning that early suppression of cytokine release through medication does not affect the efficacy of TCE antibodies. However, the data disclosed by Johnson & Johnson this time is the first clinical validation of this concept, and it also lays the foundation for future TCE treatments that may not require patients to be hospitalized for observation.

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