Cerus reported Monday, November 2, that its Phase 3 RedeS trial met its primary hemoglobin-response endpoint for INTERCEPT-treated red blood cells compared with conventional red blood cells. The investigational U.S. system also produced treatment-emergent antibodies in 2.2% of treated patients versus none in the control group, a finding the company continues to study.
The 4 p.m. Eastern company announcement distributed by Business Wire says the FDA has not reviewed the final RedeS clinical study report. The red blood cell system has not received U.S. FDA authorization, and the agency may reach a different assessment of the findings and overall benefit-risk profile from Cerus. The topline results do not establish a regulatory outcome or its timing.
In the modified intention-to-treat analysis, adjusted hemoglobin increment was 1.996 grams per deciliter in 195 patients receiving INTERCEPT red blood cells, compared with 2.050 grams per deciliter in 199 controls. The estimated difference was -0.054 grams per deciliter, with a 95% confidence interval from -0.210 to 0.103.
The lower bound of that confidence interval was above the prespecified noninferiority margin of -0.32 grams per deciliter, meeting the trial’s primary endpoint with a p-value of 0.004. Noninferiority on this measure means the result met the study’s specified comparison threshold; it does not by itself establish a broader conclusion about every clinical outcome.
The study had two prespecified primary safety endpoints. Treatment-emergent adverse events considered possibly, probably or definitely related to study transfusions occurred in nine of 267 INTERCEPT patients, or 3.4%, and seven of 276 controls, or 2.5%. Cerus reported no statistically significant difference between those groups, with a p-value of 0.634.
The antibody finding differed between the groups: six of 267 INTERCEPT patients developed INTERCEPT red-blood-cell-specific antibodies, compared with none of 276 controls, with a reported p-value below 0.013. The company described the antibodies as low-titer and transient and said it detected no evidence of hemolysis, the breakdown of red blood cells, or clinical impact. Those are Cerus’s findings and assessment, not an FDA conclusion. The six antibody cases were included in the transfusion-related adverse-event endpoint.
Cerus said it has ongoing studies examining the nature of these antibodies, which were also observed in its earlier ReCePI study. Full RedeS results, including secondary endpoints, are expected to be submitted to a peer-reviewed journal and presented at scientific meetings. Monday’s release contains topline data, not the final published report.
The Concord, California, company develops pathogen-reduction systems for blood components. Its platelet and plasma products are separate from the red blood cell system tested in RedeS; regulatory status for those other products does not extend to this investigational system. Development has received support from the U.S. Biomedical Advanced Research and Development Authority. Further analysis and regulatory assessment remain ahead.
JBizNews Desk | Concord, California
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