- The multi-country retrospective post-approval study is the
first to investigate the safety and effectiveness of Truxima®
(biosimilar rituximab, CT-P10) in patients with diffuse large
B-cell lymphoma (DLBCL) in a real-world setting.
Celltrion Healthcare today presented new data from its
post-approval study evaluating the real-world clinical
effectiveness and safety of Truxima® (biosimilar rituximab, CT-P10)
in patients with diffuse large B-cell lymphoma (DLBCL) at the
European Hematology Association (EHA) 2021 Virtual Congress.1
CT-P10 was granted European Medicines Agency approval in 2017
for the treatment of rheumatoid arthritis (RA) and specific blood
cancers, including non-Hodgkin’s lymphoma (NHL).2 DLBCL is the most
common subtype of NHL, representing an estimated 30-40% of adult
cases.3,4,5,6
This non-interventional post-authorisation safety study (PASS)
involved the collection of patient-level data from hospital medical
records for patients with DLBCL who received CT-P10 treatment in
five European countries (United Kingdom, Spain, France, Germany and
Italy). CT-P10 treatment pattern data were collected
retrospectively during the 30-month observation period and patients
were selected based on the treatment they received as part of their
standard clinical care in a real-world setting.
The primary endpoints were overall survival (OS), progression
free survival (PFS) and summary of best responses and secondary
endpoints included safety profile and CT-P10 treatment pathways. At
30-months post-index, amongst patients taking first-line CT-P10,
67% (95% confidence interval [CI] 61.3–72.1) had not experienced
disease progression, with 74% (95% CI 69.2–79.1) overall survival.
Of the 382 patients observed, over three quarters initiated on
CT-P10 achieved complete or partial response by 30 months, with 82%
having recorded a complete response (n=312). Partial response was
seen in 12% (n=46), no response or stable disease in 4% (n=16) and
progressive disease in 2% (n=8).
CT-P10 also appeared to be generally well tolerated by patients,
with adverse events (AEs) consistent with those reported for
reference rituximab. Overall, 90% (n=351) of patients reported at
least one AE (total AEs n=2,504); 65% (n=253) experienced a grade 3
or higher AE, and 28% (n=109) were recorded as definitely,
probably, or possibly related to CT-P10.
“This is the first multi-country retrospective post-approval
study to investigate the effectiveness and safety of CT-P10
treatment in patients with DLBCL in a real-world setting across
Europe,” said Dr. Mark Bishton, Consultant Haematologist and
Honorary Clinical Associate Professor at the University of
Nottingham, School of Medicine. “Over three quarters of patients
initiated on CT-P10 achieved complete or partial response by 30
months. The response rates, survival rates and overall safety
profile for CT-P10 appears consistent with those reported for
reference rituximab, which could support the use of CT-P10 in
combination with chemotherapy as a therapeutic option for
DLBCL.”
Celltrion Healthcare also presented real-world data on rapid
infusion of CT-P10 in patients with non-Hodgkin’s lymphoma (NHL)
and chronic lymphocytic leukaemia (CLL) at the EHA
Updates-in-Hematology.7 The study was the first multi-country study
to investigate the safety and effectiveness of rapid infusion of
CT-P10 in a real-world setting. Safety results suggest that rapid
infusion of CT-P10 was generally well tolerated, with only 10%
(n=20; 95% CI: 6 – 15%) of patients experiencing an
infusion-related reaction (IRR). The majority of IRRs were grade 1
or 2 (96%), with the most common IRR being fatigue (35% n=7/20 of
the patients with index IRRs), followed by nausea (30% n=6/20) and
vomiting (15% n=3/20). In terms of response, the majority of
patients achieved a complete response (74% n=142/192) or partial
response (22% n=42/192) over the 6-month observation period.
“The recommended protocol for rituximab infusion in Europe is a
slow initial infusion rate with a gradual upward titration. Rapid
infusion is often used in subsequent infusions for patients who had
no serious complications related to the first infusion,” said Dr.
HoUng Kim, Ph.D., Head of Medical and Marketing Division at
Celltrion Healthcare. “We are encouraged by the results of the
study as Truxima has demonstrated a similar IRR rate to reference
rituximab. This will allow informed, evidence-based decisions on
cost-effective treatment strategy for patients with CLL or
NHL.”
- ENDS -
Notes to Editors:
About diffuse large B-cell lymphoma (DLBCL)3,4,5,6
There are more than 60 different subtypes of non-Hodgkin’s
lymphoma (NHL), however diffuse large B-cell lymphomas (DLBCLs) are
the most common subtype accounting for 30-40% of adult NHLs. Global
epidemiological data is limited, however it is thought that the
incidence is 7 cases per 100,000 people.
DLBCL is an aggressive condition and it is common to find
patients with advanced disease at the point of diagnosis. The most
commonly exhibited symptom is one or more painless swellings, and
other general symptoms include heavy sweating at night, high
temperatures that arise with no obvious cause and weight loss. Of
DLBCL patients, 30-40% are thought to relapse and 10% of patients
have refractory disease. Patients with relapsed refractory DLBCL if
left untreated have a life expectancy of 3 to 4 months.
About Truxima® (biosimilar rituximab)8,9
Truxima® is a mAb that targets CD20, a transmembrane protein
found on the surface of most B-cells. By binding specifically to
CD20, Truxima® depletes B-cells by three main mechanisms: induction
of apoptosis, stimulation of CDC (complement-dependent
cytotoxicity) and stimulation of ADCC (antibody-dependent
cell-mediated cytotoxicity). Truxima® is approved in the EU for the
treatment of patients with non-Hodgkin lymphoma (NHL), chronic
lymphocytic leukaemia (CLL), rheumatoid arthritis (RA),
granulomatosis with polyangiitis and microscopic polyangiitis.
Truxima® is the first rituximab similar biotherapeutic product to
be prequalified by the World Health Organization (May 2020).
About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and
affordable medications to promote patients’ access to advanced
therapies. Its products are manufactured at state-of-the-art
mammalian cell culture facilities, designed and built to comply
with the US FDA cGMP and the EU GMP guidelines. Celltrion
Healthcare endeavours to offer high-quality cost-effective
solutions through an extensive global network that spans more than
110 different countries. For more information please visit:
https://www.celltrionhealthcare.com/en-us
References
1 Bishton. M., et al. Real World Clinical Effectiveness and
Safety of CT-P10 in Patients with Diffuse Large B-Cell Lymphoma:
Results from a European Non-Interventional Post Authorization
Safety Study. EHA 2021, Abstract #EP529.
2 European Medicines Agency Summary of Product Characteristics
(SmPC). Truxima. Available at
https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf
Last accessed May 2021.
3 NHL subtypes. Leukemia & Lymphoma Society. Available at:
https://www.lls.org/lymphoma/non-hodgkin-lymphoma/diagnosis/nhl-subtypes
Last accessed May 2021.
4 Raut LS, Chakrabarti PP. Management of relapsed-refractory
diffuse large B cell lymphoma. South Asian J Cancer.
2014;3(1):66‐70. doi:10.4103/2278-330X.126531.
5 Vivek Kumar et al. Recent Advances in Diffuse Large B Cell
Lymphoma. Available from:
https://www.intechopen.com/books/hematology-latest-research-and-clinical-advances/recent-advances-in-diffuse-large-b-cell-lymphoma
Last accessed May 2021.
6 Diffuse large B cell lymphoma. Cancer Research UK. Available
at:
https://www.cancerresearchuk.org/about-cancer/non-hodgkin-lymphoma/types/diffuse-large-B-cell-lymphoma
Last accessed May 2021.
7 Celltrion Healthcare, data on file.
8 European Medicines Agency Summary of Product Characteristics
(SmPC). Truxima. Available at
https://www.ema.europa.eu/en/documents/product-information/truxima-epar-product-information_en.pdf
Last accessed May 2021
9 First rituximab similar biotherapeutic products prequalified.
World Health Organization. Available at:
https://extranet.who.int/prequal/news/first-rituximab-biotherapeutic-products-prequalified
Last accessed May 2021
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