Findings were published in the medical journal Lancet, in a study titled “Brentuximab vedotin or physician’s choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial.”
Adcetris is an antibody-drug conjugate targeting CD30, a protein that is expressed on skin lesions in about 50% of patients with CTCL. The drug is being developed by Takeda Pharmaceutical and Seattle Genetics.
“Today’s publication of the positive results of the ALCANZA trial is another milestone for our brentuximab vedotin clinical program,” Dirk Huebner, executive medical director at Takeda, said in a news release. “We plan to submit the data to regulatory bodies around the world, and if approved, Adcetris would be a potential new treatment option for patients with CD30-positive CTCL, a rare, debilitating and often difficult-to-treat form of cancer.”
The trial, called ALCANZA (NCT01578499), is a randomized, open-label, international study evaluating the safety and effectiveness of Adcetris compared to standard therapies of an investigator’s choice — methotrexate or bexarotene — in about 130 patients with CD30-positive CTCL. Participants received treatment every three weeks for up to one year.
Adcetris was seen to significantly improve the objective response rates that lasted at least four months compared to standard therapies (56.3% vs. 12.5%, respectively), meeting the trial’s primary endpoint.
Secondary endpoints such as complete response rate, progression-free survival, and a reduction in symptom burden during treatment were also significantly improved in the Adcetris group.
The most common side effects associated with this treatment were peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, hair loss, itching, fever, decreased appetite, and increased blood triglycerides.
“The data from the ALCANZA trial provide compelling evidence that CTCL patients treated with Adcetris had superior outcomes across the primary and all secondary endpoints assessed in the study compared to patients in the control arm who were treated with a standard of care agent,” said Bob Lechleider, MD, senior vice president of Seattle Genetics. “These data demonstrate the potential of Adcetris to change the treatment landscape of CTCL.”
Takeda and Seattle Genetics plan to submit the trial results to regulatory agencies, including a biologics license application to the U.S. Food and Drug Administration. The FDA granted breakthrough therapy designation in November 2016 to Adcetris for the most common subtypes of CTCL, the CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL).