A post hoc analysis of patients with higher transfusion burden at baseline showed a larger percentage of patients achieved transfusion independence ? 56 days with roxadustat vs. placebo (36.1% vs 11.5%; p=0.047?).
Dr. Moshe Mittelman's presentation was selected for the "2024 Highlights of ASH"
SAN FRANCISCO, Dec. 09, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) announced today the presentation of efficacy and safety data from MATTERHORN, a Phase 3 clinical study of roxadustat for the treatment of anemia in patients with lower risk transfusion-dependent myelodysplastic syndromes (MDS) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition being held in San Diego, California December 9 - 12, 2023. The oral presentation was selected for the "2024 Highlights of ASH".
"We are excited to have our data selected for presentation as part of the 2024 Highlights of ASH. We believe that roxadustat could represent an important new therapy for patients with higher transfusion burden low-risk-MDS," said Thane Wettig, Chief Executive Officer, FibroGen. "There continues to be a significant unmet need in this patient population, and the novel mechanism of roxadustat delivered orally three times a week could represent an important new and convenient treatment alternative."
As previously disclosed, the initial analysis with all the patients who participated in the trial, showed that more patients receiving roxadustat achieved transfusion independence vs. placebo (48% vs. 33%; p=0.22). While the primary endpoint of transfusion independence (TI) for ? 56 consecutive days within the first 28 weeks of the study was not met, a post-hoc analysis, showed that roxadustat performed significantly better? than placebo in the subset of patients having higher transfusion burden?? (see table). The TI for ?56 days within the first 28 weeks of the study was 36.1% for the roxadustat group and 11.5% for the placebo group (p=0.047?), and 44.4% vs 19.2% at the end of trial, respectively. Additionally, in TI responders, more patients in the roxadustat arm vs. placebo had hemoglobin concentration increases of ?1.5 g/dL: 45.5% vs 17.4% (p=0.004)?.
% (95% CI) | Roxadustat (n=36) | Placebo (n=26) | Roxadustat vs Placebo |
TI for ?56 days within 28 weeks | 36.1% (20.8–53.8) |
11.5% (2.4-30.2) |