Seattle Genetics, Inc, a biotechnology company focused on the development and commercialisation of antibody-based therapies to treat cancer, has begun a phase 2 clinical trial evaluating Adcetris (brentuximab vedotin) in systemic lupus erythematosus (SLE, or lupus).

Lupus is a chronic autoimmune disease in which the body’s own immune system overreacts and attacks healthy organs, causing inflammation, pain, permanent organ damage or death. According to the Lupus Foundation, an estimated 5 million people throughout the world have various forms of lupus and at least 1.5 million people in the US are living with the disease. Lupus affects mostly women of childbearing age (age 15 to 44); however, men, children and teenagers develop lupus as well.

Adcetris is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on activated lymphocytes that are thought to play a key role in the development of autoimmune diseases, including lupus. The trial is designed to assess the safety and activity of Adcetris in adult patients with lupus. Adcetris is currently not approved for the treatment of lupus.

“Lupus is a debilitating autoimmune disorder that can affect many of the body’s organ systems, causing a number of serious symptoms. Treatment options are limited, with few FDA-approved disease-modifying therapeutics available,” said Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics.

“Based on a retrospective review of information collected from patients being treated with Adcetris in the US for lymphoma, we noted some patients reported clinical improvement of concomitant autoimmune diseases, including lupus. Since elevated CD30 expression has been previously reported in lupus patients, we are enthusiastic to evaluate Adcetris as a potential treatment option for this disease.”

The study is a phase 2 randomized, double-blind, placebo-controlled dose-escalation clinical trial. The primary objective is evaluation of the safety of Adcetris in adults with active lupus. In addition, the trial will evaluate the activity and pharmacokinetics of Adcetris in lupus. Adcetris will be administered every three weeks and approximately 40 patients will be enrolled at multiple centers in the United States.

According to the Lupus Foundation, an estimated 5 million people throughout the world have various forms of lupus and at least 1.5 million people in the US are living with the disease. Lupus affects mostly women of childbearing age (age 15 to 44); however, men, children and teenagers develop lupus as well.

Adcetris is being evaluated broadly in more than 30 ongoing clinical trials, including four phase 3 studies, in earlier lines of its approved HL and sALCL indications as well as in many additional types of CD30-positive malignancies, including cutaneous T-cell lymphoma, B-cell lymphomas and mature T-cell lymphomas.

Adcetris is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilising Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalisation into CD30-expressing cells.

Adcetris for intravenous injection received accelerated approval from the FDA and approval with conditions from Health Canada for two indications: (1) the treatment of patients with HL after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with sALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for Adcetris are approved under accelerated approval based on overall response rate. An improvement in patient-reported outcomes or survival has not been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Adcetris was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive HL following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. Adcetris has received marketing authorization by regulatory authorities in more than 55 countries. See important safety information below.

Seattle Genetics and Takeda are jointly developing Adcetris. Under the terms of the collaboration agreement, Seattle Genetics has US and Canadian commercialisation rights and Takeda has rights to commercialise Adcetris in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.