909P Efficacy and safety of HHPG-19K for prophylaxis of chemotherapy-induced neutropenia in patients with lymphoma

Abstract

Neutropenia is a common complication of chemotherapy, which will lead to the delay or reduction of chemotherapy and affect the therapeutic effect. Mecapegfilgramtim (code name HHPG-19K), the novel long-acting rhG-CSF, has been developed. This study was evaluated the efficacy and safety of HHPG-19K for reducing neutropenia compared with un-prevention. This was a randomized, controlled non-inferiority study. A total of 151 lymphoma patients who were eligible for chemotherapy were randomly assigned into two groups, which received HHPG-19K fixed dosage of 6 mg or un-prevention in the first cycle of chemotherapy. The primary endpoint was the duration of grade≥3 neutropenia in cycle 1, incidence of grade≥3 neutropenia, and febrile neutropenia (FN). The safety profile was also evaluated. The adjusted mean duration of grade>1 neutropenia was 5 days in HHPG-19K fixed dosage of 6 mg group and 7 days in the un-prevention group (P<0.01). There was difference between the two groups in the incidence of grade≥3 neutropenia (P<0.01). There were 10 patients (12.82%) in HHPG-19K fixed dosage of 6 mg/kg group, 15 patients (20.55%) in un-prevention group experienced grade≥3 neutropenia. Compared with un-prevention group, the incidence of grade 4 neutropenia was significantly lower in patients treated with HHPG-19K fixed dosage of 6 mg/kg (7.69% vs 15.07%). For the incidence of FN, there were 5 patients (6.41%) in HHPG-19K fixed dosage of 6 mg/kg group, 11 patients (15.07%) in un-prevention group experienced FN (P<0.05). For safety profile, HHPG-19K group were all well-tolerated. The frequent AEs were ostalgia (13.70 vs 6.41%), fever (24.66% vs 11.54%), nausea (21.92% vs 1.28%), emesis (16.44% vs 1.28%), weakness (9.59% vs 2.56%) and others (19.18% vs 10.26%) during the chemotherapy, which were inferior to the un-prevention group (P<0.01). The frequent AEs were ostalgia (6.41 vs 13.70%), fever (11.54% vs 24.66%), nausea (1.28% vs 21.92%), emesis (1.28% vs 16.44%), weakness (2.56% vs 9.59%) and others (10.26% vs 19.18%) during the chemotherapy, which were inferior to the un-prevention group (P<0.01). No unexpected AE was observed. This study provided new evidence for HHPG-19K, which would be a new alternative clinical practice for prophylaxis of chemotherapy induced neutropenia.