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In the pivotal phase 2 trial, 33% of heavily pre-treated post-ASCT Hodgkin lymphoma patients achieved complete remission (n=34/102)
Adapted from Adcetris Summary of Product Characteristics6
Adapted from Chen et al. 2016
Adapted from Chen et al. 2016
Adapted from Chen et al. 2016
CR (n=34) | PR (n=39) | |
---|---|---|
Completed treatment n (%) | 12 (35) | 4 (10) |
PD n (%) | 4 (12) | 23 (59) |
AE n (%) | 9 (26) | 5 (13) |
Investigator decision | 7 (21) | 4 (10) |
Patient decision n (%) | 2 (6) | 3 (8) |
n=102 | |
---|---|
Patients experiencing PN, n (%) | 56 (55%) |
PN outcome, %
n=56
73% 14% |
|
Ongoing PN Grade ≤2 at last follow-up, n (%) | 15 (27%) |
Grade ≥3 PN at last follow-up | 0 |
“It is a great relief for patients and their doctors that we will continue to have access to ADCETRIS for relapsed or refractory Hodgkin lymphoma. This medicine has become the backbone of treatment following recurrence of disease after ASCT and has transformed outcomes for these patients since it became available in the UK in 2012.”
Consultant in Haematology, Bristol
Haematology and Oncology Centre
Younes A, et al. J Clin Oncol. 2012; 30: 2183-9
An international, multicentre trial of ADCETRIS was designed to determine the objective response rate (ORR) in heavily pre-treated post-ASCT patients, with key endpoints assessed by an Independent Review Facility (IRF)1
*Key inclusion criteria: prior ASCT, CD30+ disease, fluorodeoxyglucose-avid disease by positron emission tomography scan, measurable disease of ≥1.5 cm by spiral computed tomography, evidence of relapsed or refractory disease, US: age ≥12 years, ex-US: age ≥18 years, ECOG performance status of 0 or 1, no documented abnormality of laboratory values, no previous ADCETRIS treatment, no allogeneic transplant.
**As measured by IRF per the Revised Response Criteria for Malignant Lymphoma: CR=disappearance of all evidence of disease; PR=regression of measurable disease by ≥50% in each of up to 6 dominant masses, no new sites of disease, and no increase in size of other nodes, spleen, or liver. Assessments by PET and/or CT scan.
Chen R, et al. Blood. 2016; 128 (12): 1562-6
Younes A, et al. J Clin Oncol. 2012; 30: 2183-9
An international, multicentre trial of ADCETRIS was designed to determine the objective response rate (ORR) in heavily pre-treated post-ASCT patients, with key endpoints assessed by an Independent Review Facility (IRF)1
*Key inclusion criteria: prior ASCT, CD30+ disease, fluorodeoxyglucose-avid disease by positron emission tomography scan, measurable disease of ≥1.5 cm by spiral computed tomography, evidence of relapsed or refractory disease, US: age ≥12 years, ex-US: age ≥18 years, ECOG performance status of 0 or 1, no documented abnormality of laboratory values, no previous ADCETRIS treatment, no allogeneic transplant.
**As measured by IRF per the Revised Response Criteria for Malignant Lymphoma: CR=disappearance of all evidence of disease; PR=regression of measurable disease by ≥50% in each of up to 6 dominant masses, no new sites of disease, and no increase in size of other nodes, spleen, or liver. Assessments by PET and/or CT scan.
Visit of earliest best response (Day 15–21), n (%) | |
---|---|
Cycle 2 | 2 (15) |
Cycle 4 | 5 (38) |
Cycle 7 | 3 (23) |
Cycle 10 | 2 (15) |
Cycle 16 | 1 (8) |
Adverse events should be reported. In the United Kingdom, reporting forms and information can be found at https://yellowcard.mhra.gov.uk/.
Adverse events should also be reported to Takeda on 01628 537900 or e-mail DSO-UK@takeda.com.
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UK/ADC/1707/0053u(1) - August 2018