833P - Latest results of GVM±R regimen for the salvage therapy of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma

Background

Effective salvage chemotherapy is crucial for patients (pts) with relapsed or refractory(R/R) aggressive non-Hodgkin lymphoma (aNHL). A study on the safety and effectiveness of GVM±R regimen for R/R aNHL was presented in the 2023 ASH (abstract 6232), here we updated the latest data.

Methods

This phase I study utilized a 3+3 dose-escalation design with four levels of mitoxantrone hydrochloride liposome (PLM60) (16, 18, 20 and 22 mg/m²) to determine the maximum tolerated dose and recommended Phase II dosage (RP2D) of PLM60 in the GVM regimen (gemcitabine 800 mg/m²and vinorelbine 20 mg/m² on day 1 and 8, PLM60 on day 1).

Results

As of November 28, 2023, the study enrolled 18 R/R aNHL pts. (Table) Three patients experienced dose-limiting toxicities (DLTs) of grade 4 neutropenia lasting for more than 7 days at doses of 16, 18, and 20 mg/m², respectively. Hematologic toxicity was the most common adverse event, with grade 3 febrile neutropenia and pneumonia each occurring at a rate of 16.7%. At data cut-off on March 14, 2024, the objective response rate (ORR) was 66.7% (12/18) and the complete response (CR) rate was 50.0% (9/18). The ORR was 71.4% (5/7) and 63.6% (7/11), and the CR rate was 71.4% (5/7) and 36.4% (4/11) for DLBCL and T/NK lymphoma, respectively. Among pts with a history of resistance to anthracyclines, the ORR was 50% (4/8) and the CR rate was 37.5% (3/8). After a median follow-up of 9.1 months (95%CI 6.4-11.8 ), the median progression-free survival was 11.0 months (95%CI 0.0-22.6), median overall survival (OS) has not yet been reached, and the 1-year OS rate was 63.4%. Following evaluation by the Data and Safety Monitoring Board, PLM60 18mg/m² was established as the RP2D due to the elevated hematologic toxicity observed after multiple treatment cycles and preliminary efficacy data. Table: 833P

Patient characteristics

Conclusions

The GVM±R regimen exhibited manageable safety and encouraging efficacy in pts with R/R aNHL. The phase II study (NCT06244368) with dose expansion at RP2D is currently ongoing.

Clinical trial identification

NCT05299164.

Editorial acknowledgement

Legal entity responsible for the study

Blood Diseases Hospital, Chinese Academy of Medical Sciences.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.