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ASCO 2018 | Phase Ib/II study of Hu5F9-G4 in R/R NHL
On Sun 3rd June an oral abstract session took place at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. Abstract 7504 was presented by Ranjana Advani, Stanford Cancer Institute, California, on the phase 1b/2 study of Hu5F9-G4 first-in-class anti-CD47 antibody (5F9). The aim of the study was to assess the safety and efficacy of 5F9 (NCT02953509).
Patients with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) were included in the study if they had failed previous lines of therapy. The study consisted of a phase Ib dose escalation in which patients received a priming dose with 5F9 (1 mg/kg) up to a maintenance dose of 10–30 mg/kg with rituximab.
Key Findings
- 22 patients were treated in the phase Ib study. 15 patients had diffuse large B-cell lymphoma (DLBCL) and 7 patients had follicular lymphoma (FL)
- The maximum tolerated dose (MTD) was not reached
- The recommended phase II dose (RP2D) was a priming dose of 5F9 1 mg/kg followed by 5F9 30 mg/kg maintenance weekly dose Q2 weeks after cycle 1
- The overall response rate was 50% and 32% of patients achieved a complete response (43% in the FL group and 33% in the DLBCL group)
- The median duration of response was no reached
The results of the study showed that the combination of 5F9 and rituximab was well tolerated with promising clinical activity in patients with R/R FL and DLBCL. Trials are ongoing for further analysis.
References