ADCETRIS (brentuximab vedotine) (lymphome de Hodgkin)

Key points

Maintenance of the favourable opinion for reimbursement in the treatment of adult patients with CD30+ Hodgkin lymphoma (HL) at increased risk of relapse or progression following autologous stem cell transplant (ASCT).

What therapeutic improvement?

Therapeutic improvement in the management of the condition.

Role in the care pathway?

The first-line treatment of classic Hodgkin lymphoma (HL) in adult patients is based on chemotherapy protocols.

In the event of relapse after this first-line treatment, the favoured second-line treatment is high-dose (“salvage”) chemotherapy, followed by autologous stem cell transplant (ASCT).

Autologous stem cell transplantation (ASCT) leads to durable complete remission in around 50% of patients. Post-ASCT relapse or progression generally occurs early on: in 70% of cases it occurs in the year following the transplant, and in 90% of cases it occurs within 2 years. In these patients presenting relapse/progression, the median survival is around 16 months and the 5-year survival rate is approximately 20%. Apart from ADCETRIS (brentuximab vedotin), there is currently no specific or recommended treatment to prevent post-ASCT relapse/progression.

As third-line treatment in refractory or relapsed patients post-ASCT, treatment with ADCETRIS (brentuximab vedotin) is recommended. In refractory or relapsed patients after brentuximab vedotin, salvage therapies with nivolumab or pembrolizumab may be envisaged (fourth line).

Role of the medicinal product in the care pathway

In the indication claimed, ADCETRIS (brentuximab vedotin) remains a first-line treatment for adult patients at increased risk of relapse or progression following ASCT, defined as those with:

• a history of disease refractory to chemotherapy, or
• relapse or disease progression within 12 months following first-line treatment, or
• extranodal involvement at the time of pre-ASCT relapse.

Its superiority has been established compared to placebo only in terms of progression-free survival. The absence of demonstration of an improvement in overall survival means that it is not possible to clearly define the advantage of preventive treatment for post-ASCT relapse or progression with brentuximab vedotin compared to treatment of relapse by brentuximab vedotin.