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Kidney Week

Abstract: INFO19

Two Phase 3 Trials Evaluating Crovalimab in Patients With Atypical Haemolytic Uraemic Syndrome (aHUS): COMMUTE-a and COMMUTE-p

Session Information

  • Informational Posters
    November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category: Genetic Diseases of the Kidneys

  • No subcategory defined

Authors

  • Sheerin, Neil S., Newcastle University, Newcastle upon Tyne, Tyne and Wear, United Kingdom
  • Greenbaum, Larry A., Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, United States
  • Ito, Shuichi, 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, Beijing, China
  • Benkali, Khaled, Certara, Inc., Paris, France
  • Pieterse, Christelle, F. Hoffmann-La Roche Ltd., Basel, Switzerland
  • Shah, Mona D., 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

Introduction
Atypical haemolytic uraemic syndrome (aHUS) is a life-threatening disease of complement dysregulation, characterised by thrombotic microangiopathy (TMA). While treatment with C5 inhibition is effective, currently approved therapies require regular intravenous infusions. Crovalimab, a novel anti-C5 monoclonal antibody, allows for small-volume, subcutaneous 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 enrol 3 cohorts of patients with aHUS aged ≥ 12 years (Figure): Naive: complement inhibitor-naive patients; Switch: patients switching from eculizumab/ravulizumab; and C5 SNP: patients with a known single-nucleotide polymorphism (SNP).

COMMUTE-p (NCT04958265) will enrol three cohorts of patients with aHUS aged ≥ 28 days to
< 18 years (Figure): Naive: complement inhibitor-naive patients; Switch: patients switching from eculizumab/ravulizumab; and Pretreated: patients who received and discontinued prior eculizumab/ravulizumab treatment.

In both the COMMUTE-a and COMMUTE-p trials, patients will receive weight-based crovalimab as a weekly loading series (Weeks 1-4), followed by self-administered, subcutaneous maintenance doses (Weeks 5 and after; once every 4 weeks or once every 2 weeks if < 20 kg). The primary objective for both studies is to evaluate the efficacy of crovalimab in Naive patients, based on the proportion of patients with complete TMA response any time from baseline to Week 25.

Results
COMMUTE-a and COMMUTE-p are currently enrolling.

Conclusion
Both COMMUTE-a and COMMUTE-p will assess the efficacy and safety of crovalimab in patients with aHUS.

Originally presented at ASN Kidney Week 2021 – San Diego, November 2–7, 2021.

Figure: Study Schema

Funding

  • This study was funded by F. Hoffmann-La Roche, Basel, Switzerland
Abstract: INFO19

Two Phase 3 Trials Evaluating Crovalimab in Patients With Atypical Haemolytic Uraemic Syndrome (aHUS): COMMUTE-a and COMMUTE-p

Session Information

  • Informational Posters
    November 04, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Sheerin, Neil S., Newcastle University, Newcastle upon Tyne, Tyne and Wear, United Kingdom
  • Greenbaum, Larry A., Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, United States
  • Ito, Shuichi, 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, Beijing, China
  • Benkali, Khaled, Certara, Inc., Paris, France
  • Pieterse, Christelle, F. Hoffmann-La Roche Ltd., Basel, Switzerland
  • Shah, Mona D., 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

Introduction
Atypical haemolytic uraemic syndrome (aHUS) is a life-threatening disease of complement dysregulation, characterised by thrombotic microangiopathy (TMA). While treatment with C5 inhibition is effective, currently approved therapies require regular intravenous infusions. Crovalimab, a novel anti-C5 monoclonal antibody, allows for small-volume, subcutaneous 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 enrol 3 cohorts of patients with aHUS aged ≥ 12 years (Figure): Naive: complement inhibitor-naive patients; Switch: patients switching from eculizumab/ravulizumab; and C5 SNP: patients with a known single-nucleotide polymorphism (SNP).

COMMUTE-p (NCT04958265) will enrol three cohorts of patients with aHUS aged ≥ 28 days to
< 18 years (Figure): Naive: complement inhibitor-naive patients; Switch: patients switching from eculizumab/ravulizumab; and Pretreated: patients who received and discontinued prior eculizumab/ravulizumab treatment.

In both the COMMUTE-a and COMMUTE-p trials, patients will receive weight-based crovalimab as a weekly loading series (Weeks 1-4), followed by self-administered, subcutaneous maintenance doses (Weeks 5 and after; once every 4 weeks or once every 2 weeks if < 20 kg). The primary objective for both studies is to evaluate the efficacy of crovalimab in Naive patients, based on the proportion of patients with complete TMA response any time from baseline to Week 25.

Results
COMMUTE-a and COMMUTE-p are currently enrolling.

Conclusion
Both COMMUTE-a and COMMUTE-p will assess the efficacy and safety of crovalimab in patients with aHUS.

Originally presented at ASN Kidney Week 2021 – San Diego, November 2–7, 2021.

Figure: Study Schema

Abstract: INFO19

Two Phase 3 Trials Evaluating Crovalimab in Patients With Atypical Haemolytic Uraemic Syndrome (aHUS): COMMUTE-a and COMMUTE-p

Session Information

  • Informational Posters
    November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
    Abstract Time: 10:00 AM - 12:00 PM

Category:

  • No subcategory defined

Authors

  • Sheerin, Neil S., Newcastle University, Newcastle upon Tyne, Tyne and Wear, United Kingdom
  • Greenbaum, Larry A., Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia, United States
  • Ito, Shuichi, 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, Beijing, China
  • Benkali, Khaled, Certara, Inc., Paris, France
  • Pieterse, Christelle, F. Hoffmann-La Roche Ltd., Basel, Switzerland
  • Shah, Mona D., 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

Introduction
Atypical haemolytic uraemic syndrome (aHUS) is a life-threatening disease of complement dysregulation, characterised by thrombotic microangiopathy (TMA). While treatment with C5 inhibition is effective, currently approved therapies require regular intravenous infusions. Crovalimab, a novel anti-C5 monoclonal antibody, allows for small-volume, subcutaneous 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 enrol 3 cohorts of patients with aHUS aged ≥ 12 years (Figure): Naive: complement inhibitor-naive patients; Switch: patients switching from eculizumab/ravulizumab; and C5 SNP: patients with a known single-nucleotide polymorphism (SNP).

COMMUTE-p (NCT04958265) will enrol three cohorts of patients with aHUS aged ≥ 28 days to
< 18 years (Figure): Naive: complement inhibitor-naive patients; Switch: patients switching from eculizumab/ravulizumab; and Pretreated: patients who received and discontinued prior eculizumab/ravulizumab treatment.

In both the COMMUTE-a and COMMUTE-p trials, patients will receive weight-based crovalimab as a weekly loading series (Weeks 1-4), followed by self-administered, subcutaneous maintenance doses (Weeks 5 and after; once every 4 weeks or once every 2 weeks if < 20 kg). The primary objective for both studies is to evaluate the efficacy of crovalimab in Naive patients, based on the proportion of patients with complete TMA response any time from baseline to Week 25.

Results
COMMUTE-a and COMMUTE-p are currently enrolling.

Conclusion
Both COMMUTE-a and COMMUTE-p will assess the efficacy and safety of crovalimab in patients with aHUS.

Originally presented at ASN Kidney Week 2021 – San Diego, November 2–7, 2021.

Figure: Study Schema