New data show Roche’s subcutaneously administered crovalimab
achieved disease control and was well-tolerated in people with
paroxysmal nocturnal haemoglobinuria (PNH)
- The COMMODORE 2 study
demonstrated that subcutaneous crovalimab every four weeks was
non-inferior to intravenous eculizumab every two weeks, with
comparable safety, in people new to C5
inhibitors1
- Monthly self-administration
of subcutaneous crovalimab has the potential to address the high
burden of a disease that requires lifelong treatment including in
settings where access to current C5 inhibitors is
limited1,2
- The COMMODORE 1 study in
people switching from currently approved C5 inhibitors supported
the consistent benefit-risk profile of crovalimab as seen in the
COMMODORE 2 study3
Basel, 09 June 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that positive results from the global phase III
COMMODORE 1 and 2 studies, evaluating the efficacy and safety of
crovalimab, an investigational, novel anti-C5 recycling monoclonal
antibody, compared to eculizumab, a current standard of care in
paroxysmal nocturnal haemoglobinuria (PNH) were presented at the
European Hematology Association (EHA) Hybrid Congress, taking place
in Frankfurt, Germany on 8-11 June 2023.
“With the option for subcutaneous self-administration,
crovalimab could help meet the lifelong needs of people living with
PNH and their caregivers,” said Levi Garraway, M.D., Ph.D., Roche’s
Chief Medical Officer and Head of Global Product Development. “Data
from the COMMODORE studies will be submitted to regulatory
authorities around the world.”
PNH is a rare and life-threatening blood condition, in which red
blood cells are destroyed by the complement system — part of the
innate immune system — causing symptoms such as anaemia, fatigue,
blood clots and kidney disease.4 C5 inhibitors have been shown to
be effective in treating the condition.5 Crovalimab has been
engineered to be recycled within the bloodstream, enabling
sustained complement inhibition through low dose, subcutaneous (SC)
administration every four weeks.6,7
In the COMMODORE 2 study, 79.3% (95% CI: 72.9, 84.5) of
participants randomised to be treated with crovalimab achieved
haemolysis control from week five to week 25 compared with 79.0%
(95% CI: 69.7, 86.0) with eculizumab. Additionally, 65.7% (95% CI:
56.9, 73.5) achieved transfusion avoidance (TA) from baseline to
week 25 with crovalimab and 68.1% (95% CI: 55.7, 78.5) with
eculizumab. TA is defined as people who become transfusion-free and
do not require transfusion per protocol-specified guidelines. Blood
transfusion requirements are important clinical measures of
haemolysis caused by complement dysregulation in PNH. A clinically
meaningful improvement in FACIT-Fatigue score from baseline to week
25 occurred in both arms, with a numerically greater improvement
with crovalimab (adjusted mean change 7.8 (95% Cl: 6.5, 9.1)),
versus eculizumab (adjusted mean change 5.2 (95% Cl: 3.4,
6.9)).1
Adverse events (AEs) occurred in 78% of participants treated
with crovalimab and 80% treated with eculizumab in the COMMODORE 2
study. Serious infections occurred in 3% of participants treated
with crovalimab and 7% of participants treated with eculizumab,
with no meningococcal infections. The most common AE, occurring in
16% of people treated with crovalimab and 13% of people treated
with eculizumab was an infusion-related reaction. One participant
in each arm experienced an AE that led to treatment
discontinuation.1
The results from the COMMODORE 1 study indicate that crovalimab
maintained disease control in people switching from currently
approved complement inhibitors.3 The data support the consistent
benefit-risk profile of crovalimab, as well as SC administration
with the option to self-administer, as seen in the COMMODORE 2
study.
Roche also presented preliminary data from the COMMODORE Burden
of Illness study, which suggest that despite currently available C5
inhibitor treatments, people with PNH continue to experience
substantial burden of disease, which can translate into diminished
quality of life and considerable costs. These data suggest that
people with PNH may benefit from alternative treatment
options.8
Global phase III data from the COMMODORE 1 and 2 studies in PNH
will be submitted to regulatory authorities around the world.
Positive data from a third phase III study evaluating crovalimab in
PNH, the COMMODORE 3 study in China, were presented at the American
Society of Hematology (ASH) Annual Meeting and Exposition on 10
December 2022. Data from the COMMODORE 3 study have been submitted
via China’s Centre for Drug Evaluation Breakthrough Therapy
Designation pathway. This submission has been accepted under
Priority Review for approval consideration by China’s National
Medical Products Administration.
About crovalimabCrovalimab is an
investigational, novel anti-C5 recycling monoclonal antibody
designed to block the complement system – a vital part of the
innate immune system that acts as the body’s first line of defence
against infection. Crovalimab, which was created by Chugai
Pharmaceutical Co., Ltd, has been engineered to address the medical
needs of people living with complement-mediated diseases, including
providing patients with a potential self-administration option.
Crovalimab works by binding to C5, blocking the last step of the
complement cascade and is also recycled within the bloodstream,
enabling rapid and sustained complement inhibition.6,7 Crovalimab’s
recycling properties also enables low dose SC administration every
four weeks. In addition, crovalimab binds to a different C5 binding
site from current treatments, which has the potential to provide a
treatment option for people with specific C5 gene mutations, who do
not respond to current therapies.6 It is also being evaluated in
atypical haemolytic uraemic syndrome, sickle cell disease, and
other complement mediated diseases.
About the COMMODORE 1 and 2 studiesThe
COMMODORE 2 study is a phase III, randomised, open-label study
evaluating the efficacy and safety of crovalimab versus eculizumab
in people with paroxysmal nocturnal haemoglobinuria (PNH) who have
not been treated previously with C5 inhibitors. The 204 adults
enrolled in the study were randomised in a 2:1 ratio, to be treated
with either subcutaneous (SC) crovalimab every four weeks or
intravenous (IV) eculizumab every two weeks. The six participants
who were less than 18 years old were included in a non-randomised
arm, to be treated with SC crovalimab every four weeks.9
The COMMODORE 1 study is a phase III, randomised, open-label
study evaluating the safety of crovalimab in people with PNH
switching from currently approved C5 inhibitors. The study included
89 people (18 years of age or older) currently treated with
eculizumab, randomised in a 1:1 ratio to be treated with either SC
crovalimab every four weeks or IV eculizumab every two weeks. In a
non-randomised arm, the study also included paediatrics (<18
years of age) currently treated with eculizumab, people currently
treated with ravulizumab, people currently treated with off-label
doses of eculizumab (higher than the approved dose for PNH: more
than 900mg per dose and/or more frequently than every two weeks),
or people with known mutations in the C5 gene who do not respond to
current therapies. 10
About Roche Founded in 1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.References[1] Roth A, et al. The Phase III,
Randomised COMMODORE 2 Trial: Results from a Multicentre Study of
Crovalimab vs Eculizumab in Paroxysmal Nocturnal Hemoglobinuria
(PNH) Patients Naïve to Complement Inhibitors. Presentation at
European Hematology Association (EHA) Annual Congress; 2023 June
08-13. Abstract #S181.[2] Brodsky R.A. How I treat paroxysmal
nocturnal hemoglobinuria. Blood. 2009; 113(26): 6522-6527. [3]
Scheinberg P, et al. Phase III Randomised, Multicentre, Open-Label
COMMODORE 1 Trial: Comparison of Crovalimab Vs Eculizumab in
Complement Inhibitor-Experienced Patients with Paroxysmal Nocturnal
Hemogobinuria (PNH). Presentation at European Hematology
Association (EHA) Annual Congress; 2023 June 08-13. Abstract
#S183.[4] National Organization for Rare Diseases. Paroxysmal
nocturnal hemoglobinuria. [Internet; cited June 2023]. Available
from:
https://rarediseases.org/rare-diseases/paroxysmal-nocturnal-hemoglobinuria/.[5]
Bektas M, et al. Paroxysmal nocturnal hemoglobinuria: current
treatments and unmet needs. Journal of Managed Care & Specialty
Pharmacy 2020; 26:12-b Suppl, S14-S20.[6] Fukuzawa T, et al. Long
lasting neutralisation of C5 by SKY59, a novel recycling antibody,
is a potential therapy for complement-mediated diseases. 2017; Sci
Rep 7, 1080.[7] Nishimura J, et al. An Optimized Crovalimab Dose
and Regimen Reduced the Formation of Drug-Target-Drug Complexes in
Patients with Paroxysmal Nocturnal Hemoglobinuria From the Phase
I/II COMPOSER Trial. Poster presented at: American Society Of
Hematology (ASH) Annual Meeting; 2020 December 5-8; Atlanta, GA,
USA. Abstract 1550.[8] Clinical, Humanistic, and Economic Burden in
Patients with PNH receiving C5 Inhibition Treatment Across UK,
Germany, and France. Insights from the COMMODORE Burden of Illness
Study. Presentation at European Hematology Association (EHA) Annual
Congress; 2023 June 08-13. Abstract #P783. [9] COMMODORE 2
(NCT04434092). [Internet; cited June 2023] Available at:
https://www.clinicaltrials.gov/ct2/show/NCT04434092.[10] COMMODORE
1 (NCT04432584). [Internet; cited June 2023] Available at:
https://www.clinicaltrials.gov/ct2/show/NCT04432584.
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