UK’s NICE Recommends Adcetris as Second-line Treatment for Certain CTCL Patients

After first rejecting it due to cost-effectiveness concerns, the National Institute for Health and Care Excellence (NICE) has now recommended the use of Adcetris (brentuximab vedotin) as a second-line therapy for patients with CD30-positive cutaneous T-cell lymphomas (CTCL).

This means that CTCL patients living in the U.K. may now have access to Adcetris treatment on the National Health Service (NHS). The decision was based on new evidence provided by the company that allowed NICE to clarify how much Adcetris would cost to the NHS.

“Patients and clinicians told NICE there is a real need for new treatment options in this specific type of blood cancer, so it’s great that NHS England, NICE and the company have worked together to reach this deal,” Rose Gray, Cancer Research UK‘s policy manager, said in a press release.

CTCL is a subtype of non-Hodgkin’s lymphoma that affects the skin. Symptoms include red skin patches that start to develop into tumors. In some forms of CTCL, malignant cancer cells contain a molecule called CD30 at their surface. Adcetris, by Seattle Genetics, works by binding to the CD30 molecule and then by delivering a compound called monomethyl auristatin E that kills cancer cells.

In a previous randomized, open-label Phase 3 clinical trial (NCT01578499), called ALCANZA, Adcetris was shown to stop CTCL progression, outperforming the chemotherapy agents methotrexate or Targretin (bexarotene), which are considered the standard therapies for patients with CTCL.

According to ALCANZA’s findings, 56% of the patients treated with Adcetris for four months saw their tumors shrink, clearly surpassing the 12% reaching the same outcome on standard treatments.

In addition, Adcetris prolonged patients’ progression-free survival (the time patients lived without their disease worsening) to 16.5 months, more than four times that of patients on standard therapies (3.5 months).

“This drug has shown great benefits in clinical trials for patients with more aggressive disease. Compared to existing treatment options, more patients saw their cancer shrink after receiving the drug, and it also substantially delayed the spread of their cancer,” Gray said.

Although patients treated with Adcetris experienced fewer severe side effects than those on standard therapies, a significant portion of patients treated with Adcetris (69%) reported tingling or pain sensations in their fingers or toes, a condition known as peripheral neuropathy.

The treatment will be available for patients with the two most common forms of CTCL, mycosis fungoides, and Sezary syndrome, and can be started before patients undergo a stem cell transplant, or as a stand-alone treatment.

The treatment is also approved for four Hodgkin’s lymphoma indications in the European Union, including newly diagnosed metastatic patients, those who failed an autologous stem cell transplant, those who received a stem cell transplant but are at high risk of progressing, and those unfit for a stem cell transplant and who received at least two prior lines of treatment. It is also approved for systemic anaplastic large cell lymphoma patients who failed prior treatments.