Adcetris: antibody-drug conjugate for lymphoma

Adcetris (brentuximab vedotin) is licensed for the treatment of relapsed or refractory Hodgkin's lymphoma and systemic anaplastic large cell lymphoma.

Adcetris has demonstrated clinical benefit in terms of disease control, resolution of B-symptoms and enabling further potentially curative treatment options.
Adcetris has demonstrated clinical benefit in terms of disease control, resolution of B-symptoms and enabling further potentially curative treatment options.

PHARMACOLOGY

Brentuximab vedotin is an antibody–drug conjugate (ADC) that delivers an antineoplastic agent (monomethyl auristatin E [MMAE]) into CD30-expressing tumour cells. After the ADC binds to CD30 on the cell wall, the resulting complex is internalised and MMAE released via proteolytic cleavage. MMAE then binds to tubulin, disrupting the microtubule network and causing cell cycle arrest and apoptosis.1,2

CLINICAL STUDIES

Study design

The safety and efficacy of brentuximab vedotin as monotherapy were assessed in two phase II, single-arm, open-label studies. All participants received the recommended starting dose of 1.8mg/kg intravenously over 30 minutes every three weeks.1

The primary endpoint in both trials was the overall objective response rate (ORR), defined as complete remission (CR) and partial remission combined. Secondary endpoints included CR rate, duration of response, progression-free survival (PFS), overall survival (OS) and the incidence and severity of side-effects.1

Results in Hodgkin's lymphoma

The first study involved 102 patients with relapsed or refractory Hodgkin’s lymphoma who had undergone ASCT and a median of 3.5 prior chemotherapy regimens. The ORR was 75% (95% CI 64.9–82.6), with CR observed in 34% of patients. In patients who achieved CR, the median duration of response was 20.5 months. Median PFS for all patients was 5.6 months.2

Efficacy data in sALCL

The second study involved 58 patients with relapsed or refractory sALCL, of whom 26% had undergone ASCT. The ORR in these patients was 86% (95% CI 74.6–93.9) and CR lasted a median of 13.2 months.3

Safety and tolerability

The adverse effects most commonly observed with brentuximab vedotin were peripheral sensory neuropathy, nausea and fatigue.1

References

  1. Adcetris Summary of Product Characteristics, November 2012.
  2. Younes A et al. J Clin Oncol 2012; 30: 2183–9.
  3. Pro B et al. J Clin Oncol 2012; 30: 2190–6.

View Adcetris drug record

Further information: Takeda UK Ltd

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