ADCETRIS is effective and provides long term overall survival in patients with a poor prognosis who relapse post-ASCT1-6
In the pivotal phase 2 trial, 33% of heavily pre-treated post-ASCT Hodgkin lymphoma patients achieved complete remission (n=34/102)
- The estimated 5-year OS rate was 41% (95% CI: 31-51)
Objective response rate6
Adapted from Adcetris Summary of Product Characteristics6
ADCETRIS delivers durable response and survival in CR patients1,2
- In this heavily pre-treated population, 38% (13/34) of CR patients have achieved long-term disease control
- Median PFS as per investigator analysis for CR patients has not been reached
- Median OS for CR patients has not been reached
PFS by best response following treatment with ADCETRIS2
Adapted from Chen et al. 2016
OS by best response following treatment with ADCETRIS2
Adapted from Chen et al. 2016
CR patients who achieved a durable remission with ADCETRIS may not require consolidative alloSCT for long term survival2
- 15 patients remain in follow-up and in remission (13 CR and 2 PR) following a median observation time of 69.5 months (range 66.5–72.9)
- 9 of 13 CR patients did not receive further treatment nor a consolidative alloSCT
- Further cycles can be required to achieve a CR
-
In these 13 patients:
- 7 achieved CR within 4 cycles
- 6 achieved CR between 7-16 cycles
CR patients who remain on study and in remission2
Adapted from Chen et al. 2016
ADCETRIS is generally well tolerated. PN, generally resolves / improves in the majority of patients2,3
- Grade ≥3 AEs in ≥5% of patients were 20% neutropenia, 8% sensory PN, 8% thrombocytopenia, 6% anaemia
- Patients received a median of nine cycles (1-16) of brentuximab vedotin1
Reasons for treatment discontinuation
| 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) |
Resolution of peripheral neuropathy
| 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 |
NICE has recommended ADCETRIS as a cost-effective option for treating adult CD30+ patients with R/R HL post-ASCT
Professor Radford explains the approved funding for these patients:
“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.”
Treatment of relapsed or refractory (R/R) Hodgkin lymphoma (HL) patients post-ASCT with brentuximab vedotin
Dr Stephen Robinson
Consultant in Haematology, Bristol
Haematology and Oncology Centre
Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients With Relapsed or Refractory Hodgkin’s Lymphoma1-5
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
- Phase 2, single-arm, open-label trial
- 25 centres in US, France, Canada, Italy and Belgium
- CD30+ R/R HL patients* (n=102)
- All patients had a prior ASCT
- Primary endpoint: Anti-tumour efficacy as measured by ORR**
- Secondary endpoints: Complete response (CR),** duration of response (DOR),**progression-free survival (PFS),** overall survival (OS), safety and tolerability, pharmacokinetics
- Dose: 1.8 mg/kg administered as an intravenous (IV) infusion over 30 minutes every 3 weeks
- Planned treatment duration: 8 Q3W cycles minimum, continuing to a maximum of 16 cycles, unless disease progression or unacceptable toxicity5
- Median number of prior chemotherapy regimens was 3.5 (range 1–13)1
- 42% patients were refractory to their last treatment1
- Median time to first post-ASCT relapse was 6.7 months1
- 71% relapsed within a year of ASCT1
- Patients received a median of 9 cycles of ADCETRIS 1.8 mg/kg (range 1–16)1
- Up to 16 cycles are recommended for patients achieving SD or better6
*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.
Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma
Chen R, et al. Blood. 2016; 128 (12): 1562-6
- 5-year end-of-study results from the pivotal phase 2 trial of brentuximab vedotin in patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) after failed hematopoietic autologous stem cell transplantation (Younes et al 2012, JCO)
- All patients completed treatment as of August 2010 and were followed for progression and survival until the end of study
- Assessments: Q3 mos for 2 yrs, Q6 mos yrs 3-5, Q12 mos >5 years
- CT scans only required if progression suspected clinically, subsequent to protocol amendment (October 2013)
- At study closure, which occurred approximately 5 yrs after the last patient’s end-of-treatment visit, the median observation time for all enrolled pts from first dose was 35.1 mos (range, 1.8 to 72.9)
Results of a Pivotal Phase II Study of Brentuximab Vedotin for Patients With Relapsed or Refractory Hodgkin’s Lymphoma1-5
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
- Phase 2, single-arm, open-label trial
- 25 centres in US, France, Canada, Italy and Belgium
- CD30+ R/R HL patients* (n=102)
- All patients had a prior ASCT
- Primary endpoint: Anti-tumour efficacy as measured by ORR**
- Secondary endpoints: Complete response (CR),** duration of response (DOR),*progression-free survival (PFS),* overall survival (OS), safety and tolerability, pharmacokinetics
- Dose: 1.8 mg/kg administered as an intravenous (IV) infusion over 30 minutes every 3 weeks
- Planned treatment duration: 8 Q3W cycles minimum, continuing to a maximum of 16 cycles, unless disease progression or unacceptable toxicity5
- Median number of prior chemotherapy regimens was 3.5 (range 1–13)1
- 42% patients were refractory to their last treatment1
- Median time to first post-ASCT relapse was 6.7 months1
- 71% relapsed within a year of ASCT1
- Patients received a median of 9 cycles of ADCETRIS 1.8 mg/kg (range 1–16)1
- Up to 16 cycles are recommended for patients achieving SD or better6
- Follow up at 5yrs has been reported2,3
*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.
Study details
Study details
Study details
Time to achieve complete remission (n=13)3
| 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) |
- Time to achieve a CR ranged from 2–16 cycles - a median of 14 cycles was received
References
- Younes A, et al. J Clin Oncol. 2012; 30: 2183-9
- Chen R, et al. Blood. 2016; 128 (12): 1562-6
- Chen R, et al. Poster presented at ASH 2015. Abstract 2736
- Gopal AK, et al. Blood. 2015; 125(8): 1236-1243
- Takeda UK Ltd. - Data on File - UK/DF/1605/0013
- ADCETRIS Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/2859/smpc
and ADCETRIS are registered trademarks of Takeda Pharmaceutical Company Limited.
