|The following article features coverage from the American Society of Hematology 2019 Annual Meeting. Click here to read more of Oncology Nurse Advisor‘s conference coverage.
In this ongoing trial, patients (N=74) with MF and anemia receive the erythroid maturation agent luspatercept at 21-day intervals. Patients were assigned to cohorts based on red blood cell transfusion-dependent status at baseline and whether they had been receiving treatment with ruxolitinib at the start of the study.
Data from an interim analysis of a phase 2 trial suggest that luspatercept shows efficacy in the treatment of anemia associated with myelofibrosis (MF), according to study results presented at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, held in Orlando, Florida.
In cohorts 1 and 2, patients had not received ruxolitinib, but cohort 1 patients (n=20) were nontransfusion dependent (NTD), and cohort 2 patients (n=21) were transfusion dependent (TD). In cohorts 3A and 3B, patients had received ruxolitinib, but cohort 3A patients (n=14) had NTD status, whereas cohort 3B patients (n=19) had TD status.
In intent-to-treat analysis, the percentages of NTD patients who showed a consistent hemoglobin improvement of 1.5 g/dL or more above baseline at each evaluation for 12 consecutive weeks were 10% in cohort 1 and 21% in cohort 3A. Patients who were initially TD demonstrated transfusion independence for 12 or more consecutive weeks at rates of 10% in cohort 2 and 32% in cohort 3B.
A mean hemoglobin increase of at least 1.5 g/dL was reported for 15% of cohort 1 patients and 57% of cohort 3A patients. A reduction in transfusion burden of 50% or more was reported for 38% of cohort 2 patients and 53% of cohort 3B patients.
Grade 3 to 4 treatment-related adverse events were reported in 5% of patients, and there were no treatment-related deaths.
The study authors indicated that in this study luspatercept has so far demonstrated activity that appears clinically significant and with a low level of grade 3 to 4 adverse events.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original abstract for a full list of disclosures.
Gerds AT, Vannucchi AM, Passamonti F, et al. A phase 2 study of luspatercept in patients with myelofibrosis-associated anemia. Oral presentation at: 61st ASH Annual Meeting & Exposition; December 7-10, 2019; Orlando, FL. Abstract 557.