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.

Evidence-based first salvage treatment with unprecedented efficacy in R/R sALCL1-4

In the pivotal phase 2 study of ADCETRIS in patients with R/R sALCL:1-3
  • 86% of R/R sALCL patients attained PR or CR
  • 59% of patients achieved a CR (95% CI: 43.2-69.8)
  • ALK- patients showed comparable response rates to ALK+ patients
    • ALK- patients (n=42): ORR = 88%; CR = 52%
    • ALK+ patients (n=16): ORR = 81%; CR = 69%
  • Reduction in tumour volume was observed in 97% of patients

Study details

Objective response rate per independent review1
Objective response rate per independent review

Adapted from Pro B et al. 2014

ADCETRIS delivers clinically relevant overall survival2

  • At a median follow up of 71.4 months (range, 0.8 to 82.4)
    • Median OS was not estimable (95% CI:21.3-NE; range, 0.8 to 82.4)
    • Estimated 5-year overall survival (OS) rate: 60% (95% CI: 47, 73)
  • 5 year OS was similar irrespective of ALK status
    • ALK-: 61% (95% CI: 47, 76)
    • ALK+: 56% (95% CI: 32, 81)
  • This provides support for the use of ADCETRIS as the standard of care first salvage therapy in R/R sALCL1,2

Study details

Overall survival2
Overall survival

Adapted from Pro et al. 2016

ADCETRIS delivers extended survival in CR patients2

  • In the 38 patients who achieved CR with ADCETRIS
    • 16 underwent consolidative SCT (alloSCT n= 8; ASCT n= 8) as the next therapy
      • median OS was not reached
    • In the remaining 22 CR patients (i.e. no SCT consolidation)
      • median OS was not reached
      • median PFS was 39.4 months (95% CI: 14.3 - NR)
    • 42% of patients (16/38) who achieved CR remain in long-term remission at a median observation time of 75.4 months (range, 69-82.4)

Study details

PFS by Best Response per Investigator (n=58)
PFS by Best Response per Investigator (n=58)

Adapted from Pro et al. 2016

ADCETRIS has a generally manageable toxicity profile3

Most common adverse events ≥20% of patients (n=58)3
Adverse event All Grades Grade 3 Grade 4
Peripheral sensory neuropathy 57% 17% -
Nausea 40% 2% -
Fatgiue 38% 3% 2%
Pyrexia 34% 2% -
Diarrhoea 29% 3% -
Rash 24% - -
Constipation 22% 2% -
Neutropenia 21% 12% 9%

Other Grade 3/4 events: 14% thrombocytopenia, 7% anaemia, 5% recurrent ALCL

Adapted from Pro et al. 2014

PN is generally reversible and manageable through dose modification2

PN is generally reversible

Adapted from Pro et al 2016

  • The majority of patients with ongoing peripheral neuropathy (8/11) had a maximum severity of Grade 1 at last follow-up
  • For those PN events that resolved, the median time from onset to resolution was 14 weeks

Study details

Scotland
Not funded. Available via IPTR/private funding
Northern Ireland
Funding pending implementation of positive NICE guidance
England
Funded in R/R sALCL adult patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Wales
Funding pending implementation of positive NICE guidance

Impact of ADCETRIS on the management of relapsed/refractory sALCL in the UK

Dr Graham Collins

Oxford University Hospitals NHS Trust, Oxford, UK

Dr Adam Gibb

The Christie Hospital, Manchester, UK

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.