Phase I study of glofitamab in Japanese patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

What was studied

This phase I study tested glofitamab in Japanese patients. They had relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). Glofitamab is a bispecific antibody. It engages T cells. Patients got obinutuzumab 1000 mg first. It came 7 days before glofitamab. Glofitamab was stepped up on Cycle 1 Day 1 and Day 8. It then went at target dose every 3 weeks. Cohort 1 used 2.5/10/16 mg. Cohort 2 used 2.5/10/30 mg. Dosing went on until progression. The main aims were safety and pharmacokinetics. Efficacy was secondary.

What they found

8 patients with B-NHL were enrolled. 5 were in Cohort 1 and 3 in Cohort 2. Median age was 64.5 years. The patients with follicular lymphoma got no glofitamab. They had blood-related adverse events (AEs) after obinutuzumab. Median glofitamab cycles were 48 in Cohort 1 and 43 in Cohort 2. No grade 5 AEs were reported. 7 patients had grade 3/4 AEs. No dose-limiting toxicities were seen. Cytokine release syndrome occurred in all treated patients. It came mostly in Cycle 1. Drug levels looked similar in both cohorts. Responses came in 3/5 patients in Cohort 1 and 3/3 in Cohort 2.

What it means for patients

The authors say glofitamab had a manageable safety profile in Japanese patients. They say response rates were encouraging.

Why it is not certain yet

The sample was very small. The patients with follicular lymphoma got no glofitamab. 7 patients had grade 3/4 AEs. Cytokine release syndrome occurred in all treated patients. Efficacy was a secondary endpoint. The study had no control arm.

Source

Phase I study of glofitamab in Japanese patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

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