Abstract: INFO07
Two Phase III Trials Evaluating Crovalimab in Patients With Atypical Hemolytic Uremic Syndrome (aHUS): COMMUTE-a and COMMUTE-p
Session Information
- Informational Posters
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- No subcategory defined
Authors
- Sheerin, Neil S., Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom
- Greenbaum, Larry A., Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, United States
- Ito, Shuichi, Graduate School of Medicine, Yokohama City University, Kanagawa, Japan
- Loirat, Chantal, University Hospital Robert Debré, Paris, France
- Maruyama, Shoichi, Nagoya University Graduate School of Medicine, Nagoya, Japan
- Zhao, Ming Hui, Peking University First Hospital, Beijing, China
- Benkali, Khaled, Certara, Inc., Paris, France
- Pieterse, Christelle, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Pesonen, Tommi, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Shah, Mona D., Genentech, Inc., South San Francisco, California, United States
- Sima, Camelia S., Genentech, Inc., South San Francisco, California, United States
- Sostelly, Alexandre, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Sreckovic, Sasha, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Fakhouri, Fadi, Vaudois University Hospital Center (CHUV), Lausanne, Switzerland
Description
Background
aHUS is a life-threatening disease of complement dysregulation, manifested primarily as thrombotic microangiopathy (TMA). While treatment with C5 inhibition is effective, currently approved therapies require routine intravenous infusions. Crovalimab, a novel anti-C5 monoclonal antibody, allows for small-volume, subcutaneous (SC) self-injections. Crovalimab is being tested for treatment of aHUS in two global, Phase III single-arm trials: COMMUTE-a and COMMUTE-p.
Methods
COMMUTE-a (NCT04861259) will enroll 3 cohorts of patients (pts) with aHUS aged ≥ 12 years (Figure): Naive: complement inhibitor-naive pts; Switch: pts switching from eculizumab (ecu)/ravulizumab (ravu); and C5 SNP: pts with a single-nucleotide polymorphism (SNP) in C5 conferring ecu/ravu resistance.
COMMUTE-p (NCT04958265) will enroll 3 cohorts of pts with aHUS aged ≥ 28 days to < 18 years (Figure): Naive: complement inhibitor-naive pts; Switch: pts switching from ecu/ravu; and Pretreated: pts who received and discontinued prior ecu/ravu treatment.
In both COMMUTE-a and COMMUTE-p trials, pts will receive weight-based crovalimab as a weekly loading series (Weeks 1-4), followed by self-administered, SC Q4W (or Q2W, if < 20 kg) maintenance doses (Weeks 5 and after). The primary objective for both studies is to evaluate the efficacy of crovalimab in Naive pts, based on the proportion of pts with complete TMA response any time from baseline to Week 25.
Results
COMMUTE-a is currently enrolling and COMMUTE-p will enroll from October 2021.
Conclusions
Both COMMUTE-a and COMMUTE-p will assess the efficacy and safety of crovalimab in pts with aHUS.
Study Schema
Funding
- This study was funded by F. Hoffmann-La Roche, Basel, Switzerland.