SAFETY PROFILE OF RITUXIMAB BIOSIMILAR CT-P10 IN FOLLICULAR LYMPHOMA: A POOLED ANALYSIS OF FINAL DATA FROM CT-P10 PHASE 3 FOLLICULAR LYMPHOMA STUDIES
Author(s): ,
Christian Buske
Affiliations:
Comprehensive Cancer Center Ulm, University Hospital of Ulm,Ulm,Germany
,
Larry W Kwak
Affiliations:
Department of Hematology and Hematopoietic Cell Transplantation,City of Hope National Medical Center,Duarte,United States
,
Won Seog Kim
Affiliations:
Division of Hematology and Oncolgy,Samsung Medical Center, SungKyunKwan University School of Medicine,Seoul,Korea, Republic Of
,
SangJoon Lee
Affiliations:
Clinical Development Division,Celltrion, Inc.,Incheon,Korea, Republic Of
,
SungHyun Kim
Affiliations:
Clinical Development Division,Celltrion, Inc.,Incheon,Korea, Republic Of
,
KeumYoung Ahn
Affiliations:
Clinical Development Division,Celltrion, Inc.,Incheon,Korea, Republic Of
Michinori Ogura
Affiliations:
Department of Hematology and Oncology,Kasugai Municipal Hospital,Kasugai,Japan
EHA Library. Buske C. 06/12/20; 293688; EP1198
Dr. Christian Buske
Dr. Christian Buske
Contributions
Abstract

Abstract: EP1198

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
CT-P10 is the first rituximab biosimilar approved in the EU, US, South Korea, and many other countries. Two randomized phase 3 studies were performed to compare CT-P10 and reference rituximab (RTX) in previously untreated follicular lymphoma (FL) patients. PK equivalence and therapeutic non-inferiority between CT-P10 and RTX were demonstrated in the Advanced FL (AFL) study (Buske et al., 2019, Blood(2019) 134(supplement_1):1528), and therapeutic equivalence of CT-P10 to RTX was established in the Low tumor burden FL (LTBFL) study (Ogura et al., 2018, Lancet Haematol (2018) Nov; 5(11):e543-553).

Aims
Here we report the safety profile of CT-P10 compared with RTX in FL patients based on a pooled analysis of final data from two CT-P10 phase 3 studies.

Methods
In the AFL study, 140 previously untreated AFL patients were randomized in a 1:1 ratio to receive either CT-P10 or RTX in combination with CVP every 3 weeks for 8 induction cycles followed by rituximab maintenance treatment every 2 months for 2 years.

In the LTBFL study, 258 previously untreated LTBFL patients were randomized in a 1:1 ratio to receive either CT-P10 or RTX monotherapy every week for 4 induction cycles followed by rituximab maintenance treatment every 2 months for 2 years. A switch from RTX to CT-P10 took place after the 6th dose of the maintenance cycle at the investigator’s discretion considering the benefit and risk of the patient.

A pooled analysis of baseline characteristics and the safety profile was performed with data collected at baseline and until ≥30 days after the last study drug dose of these two completed RCT studies. Analysis was performed on pooled patients randomly assigned to the CT-P10 or RTX group in each of the two studies.

Results
The analysis set includes 398 patients, of which 186 (46.7%) were male and 212 (53.3%) were female. Median (range) age was 58 (19-88) years and 46.7% of patients were ≥60 years. Disease characteristics were well-balanced between groups in the pooled data.

Overall, the safety profile of CT-P10 was comparable with that of RTX in FL patients. A total of 177 (88.5%) patients in the CT-P10 group and 164 (82.8%) patients in the RTX group experienced at least 1 treatment emergent adverse event (TEAE), and the proportion of study drug-related TEAEs was comparable between groups (CT-P10: 57.0% vs RTX: 51.5%). Thirty-eight (19.0%) patients in the CT-P10 group and 27 (13.6%) patients in the RTX group experienced at least 1 serious TEAE (TESAE). The proportion of at least 1 study drug-related TESAE was similar between groups (CT-P10: 5.0% vs RTX: 5.1%). The incidence of malignancy was low in both groups, and no progressive multifocal leukoencephalopathy was reported from studies.

The most frequent TEAEs were infusion-related reaction (CT-P10: n=58, 29.0% vs RTX: n=58, 29.3%) followed by upper respiratory tract infection (CT-P10: n=45, 22.5% vs RTX: n=47, 23.7%) in both groups with similar incidences.

Although the condition of switching in the LTBFL was not considered in this analysis, the overall safety profile in terms of TEAEs, TESAEs, and AE of special interests from the integrated analysis was comparable between groups during the entire study period, which supports that CT-P10 is well tolerated with no clinically meaningful difference in the safety profile from RTX.

Conclusion
CT-P10 was well tolerated and showed a comparable safety profile compared to RTX in FL patients.

Session topic: 18. Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

Keyword(s): Clinical data, Non-Hodgkin's lymphoma, Rituximab, Safety

Abstract: EP1198

Type: e-Poster

Presentation during EHA25: All e-Poster presentations will be made available on the on-demand Virtual Congress platform as of Friday, June 12 at 08:30 CEST and will be accessible until October 15, 2020.

Background
CT-P10 is the first rituximab biosimilar approved in the EU, US, South Korea, and many other countries. Two randomized phase 3 studies were performed to compare CT-P10 and reference rituximab (RTX) in previously untreated follicular lymphoma (FL) patients. PK equivalence and therapeutic non-inferiority between CT-P10 and RTX were demonstrated in the Advanced FL (AFL) study (Buske et al., 2019, Blood(2019) 134(supplement_1):1528), and therapeutic equivalence of CT-P10 to RTX was established in the Low tumor burden FL (LTBFL) study (Ogura et al., 2018, Lancet Haematol (2018) Nov; 5(11):e543-553).

Aims
Here we report the safety profile of CT-P10 compared with RTX in FL patients based on a pooled analysis of final data from two CT-P10 phase 3 studies.

Methods
In the AFL study, 140 previously untreated AFL patients were randomized in a 1:1 ratio to receive either CT-P10 or RTX in combination with CVP every 3 weeks for 8 induction cycles followed by rituximab maintenance treatment every 2 months for 2 years.

In the LTBFL study, 258 previously untreated LTBFL patients were randomized in a 1:1 ratio to receive either CT-P10 or RTX monotherapy every week for 4 induction cycles followed by rituximab maintenance treatment every 2 months for 2 years. A switch from RTX to CT-P10 took place after the 6th dose of the maintenance cycle at the investigator’s discretion considering the benefit and risk of the patient.

A pooled analysis of baseline characteristics and the safety profile was performed with data collected at baseline and until ≥30 days after the last study drug dose of these two completed RCT studies. Analysis was performed on pooled patients randomly assigned to the CT-P10 or RTX group in each of the two studies.

Results
The analysis set includes 398 patients, of which 186 (46.7%) were male and 212 (53.3%) were female. Median (range) age was 58 (19-88) years and 46.7% of patients were ≥60 years. Disease characteristics were well-balanced between groups in the pooled data.

Overall, the safety profile of CT-P10 was comparable with that of RTX in FL patients. A total of 177 (88.5%) patients in the CT-P10 group and 164 (82.8%) patients in the RTX group experienced at least 1 treatment emergent adverse event (TEAE), and the proportion of study drug-related TEAEs was comparable between groups (CT-P10: 57.0% vs RTX: 51.5%). Thirty-eight (19.0%) patients in the CT-P10 group and 27 (13.6%) patients in the RTX group experienced at least 1 serious TEAE (TESAE). The proportion of at least 1 study drug-related TESAE was similar between groups (CT-P10: 5.0% vs RTX: 5.1%). The incidence of malignancy was low in both groups, and no progressive multifocal leukoencephalopathy was reported from studies.

The most frequent TEAEs were infusion-related reaction (CT-P10: n=58, 29.0% vs RTX: n=58, 29.3%) followed by upper respiratory tract infection (CT-P10: n=45, 22.5% vs RTX: n=47, 23.7%) in both groups with similar incidences.

Although the condition of switching in the LTBFL was not considered in this analysis, the overall safety profile in terms of TEAEs, TESAEs, and AE of special interests from the integrated analysis was comparable between groups during the entire study period, which supports that CT-P10 is well tolerated with no clinically meaningful difference in the safety profile from RTX.

Conclusion
CT-P10 was well tolerated and showed a comparable safety profile compared to RTX in FL patients.

Session topic: 18. Indolent and mantle-cell non-Hodgkin lymphoma - Clinical

Keyword(s): Clinical data, Non-Hodgkin's lymphoma, Rituximab, Safety

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