This section is intended for UK healthcare professionals. If you are a member of the public click here. If you have been prescribed ADCETRIS click here.

ADCETRIS gives difficult-to-treat patients a chance of a potentially curative SCT1-4

Response as per IRF in patients (n=49) treated with ADCETRIS following ≥2 prior therapies4
Response as per IRF in patients (n=49) treated with ADCETRIS following ≥2 prior therapies

Adapted from Walewski et al, 2016

Phase 4, single-arm study of ADCETRIS in patients with R/R HL ineligible for stem cell transplant or multi-agent chemotherapy3,4

  • Median DOR for patients who received ≥2 prior therapies was 3.6 months (95% CI: 3.29-6.08)
  • Median PFS (per IRF) for patients who had received ≥2 prior therapies was 4.8 months (95% CI: 2.86-5.13)
  • 22/49 patients (45%) who received ≥2 prior therapies and were not considered suitable for transplant went on to receive SCT after a median of seven cycles (range 4–16) of ADCETRIS

Study details

Retrospective UK real world evidence for ADCETRIS as 2nd salvage therapy in transplant naïve R/R HL patients5

  • Median follow up from the start of ADCETRIS: 12.0 months (0.4 - 56.7 months)
  • Median PFS for all patients 5.6 months (95% CI: 4.4 -12.2)
  • Median OS for all patients 37.2 months (95% CI: 18.3 - NR)

Study details

Objective response rates determined by local centre
Objective response rates determined by local centre
Adapted from Eyre et al 2017

Survival benefit maintained in patients who received a consolidative transplant post ADCETRIS5

AutoSCT vs AlloSCT vs No SCT

  • 34% proceeded directly to consolidation SCT after a median 4 cycles
  • 27% underwent deferred SCT after additional treatment
  • 39% did not reach SCT and have poor outcomes, with PFS of 3.0 months

Study details

PFS according to subsequent intervention
PFS according to subsequent intervention

Adapted from Eyre et al 2017

OS according to subsequent intervention
OS according to subsequent intervention

Adapted from Eyre et al 2017

SCT PFS months (95% CI) OS months (95% CI)
None 3 (2.5-4.4) 12.2 (8.1-18.3)
ASCT NR (17.0 - NR) NR (27.0-NR)
alloSCT NR (5.6 - NR) NR (37.2-NR)

Phase 4, Single-arm study of ADCETRIS in patients with R/R HL who are ineligible for stem cell transplantation or multi-agent chemotherapy3

Summary of treatment-emergent adverse events (n=60)
n (%)
Any AE / AE Grade ≥3 52 (87)/21 (35)
Drug-related AE / Grade ≥3 drug-related AE 41 (68)/11 (18)
SAE/Drug-related SAE 11 (18)/3 (5)
AE resulting in drug modification 15 (25)
AE resulting in drug discontinuation 3 (5)*
Infusion-related AE 4 (7)
On-study death 1 (2)

*Due to peripheral neuropathy, polyneuropathy, and septic shock (each n=1)
Due to septic shock, considered treatment-related

  • Grade ≥3 AE in ≥2 patients included anaemia, neutropenia (each n=3), increased AST/ALT, back pain, and pyrexia (each n=2)
  • 21/60 patients (35%) experienced PN
    • 2/60 patients (3%) experienced grade 3
    • PN was considered treatment related in 19/60 patients (32%)
    • 12/21 patients (57%) experienced complete resolution of PN
  • Of 22/60 patients (37%) with B symptoms at baseline, 20/22 patients (91%) experienced resolution at a median of 3.1 weeks (range 3.0–6.1) from initiation of study treatment

Note: Safety data are reported for all 60 patients, 49 received brentuximab vedotin after ≥2 prior therapies (within licence) and 11 patients received brentuximab vedotin after one prior therapy (outside licence)

Study details

Retrospective UK real world evidence for ADCETRIS as a 2nd salvage therapy in transplant naïve R/R HL patients5

  • Tolerability was formally assessed where possible given retrospective nature of the study
  • Brentuximab vedotin was generally well tolerated
    • No AEs reported in 64% (63/99) of patients and no previously undescribed AEs attributed to brentuximab vedotin
  • Most common AEs
    • Neutropenia
      • n=9 grade 1-2
      • n=6 grade 3-4
      • n=2 not known
    • Anaemia
      • n=7 all grades
    • Non-neutropenic infection
      • n=5 grade 1-2
      • n=4 grade 3-4
      • n=1 grade 5
    • Sensory peripheral neuropathy
      • n=7 grade 1-2
      • n=2 grade 3-4
Study details
Adverse events reported (n = 99) Worst grade Total number of events
Patients experiencing no brentuximab vedotin related toxicity 63
Neutropenia fever 0
Non-neutropenic infection 2 5
3 4
5 1
Haematological 1 4
Neutropenia 2 5
3 4
4 2
not known 2
Anaemia 1 7
Thrombocytopenia 1 1
Allergic reaction 2 2
3 1
Gastroenterological
Mucositis 1 1
Vomiting 1 1
Nausea 1 1
Constipation 1 1
Peripheral neuropathy 1 4
2 3
3 2
Rash 1 1
2 0
3 1
Flu-like symptoms 1 3
Fatigue 1 2
Myalgia 1 4
Others 3

Landmark NICE recommendation sees Takeda’s ADCETRIS become the first medicine to move from the new CDF to baseline commissioning for the treatment of patients with transplant naïve CD30+ R/R HL

Dr Graham Collins (Oxford), who took part in the CDF data collection exercise, explained the high response rate by saying that it "reflects the fact that we really do want, as practising haematologists, access to these agents for our patients and I think that we all accept that we need to engage in these processes otherwise it won't be made available."

Dr Stephen Robinson (Bristol): "Data from across the UK has demonstrated that (ADCETRIS) is an effective bridging strategy… It means that, for our patients, we have a very useful, relatively non-toxic agent that we can use in the 2nd salvage setting."

Treatment of relapsed or refractory (R/R) Hodgkin lymphoma (HL) with brentuximab vedotin as 2nd salvage

Treatment of relapsed or refractory

Dr Graham Collins

Oxford University Hospitals NHS Trust, Oxford, UK

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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.