Adcetris achieves superior outcomes in the treatment of CTCL.
Positive results from a phase 3 trial have been published in The Lancet, demonstrating the efficacy of brentuximab vedotin (Adcetris) in patients with cutaneous T-cell lymphoma (CTCL).
Brentuximab vedotin is an antibody-drug conjugate designed to target CD30, which is expressed on CTCL lesions in approximately 50% of patients, according to a press release.
“The ALCANZA study is the first randomized phase 3 clinical trial to evaluate a novel agent versus standard of care in CTCL, an incurable and disfiguring disease with few treatment options that achieve durable responses,” Bob Lechleider, MD, senior vice president of Clinical Development at Seattle Genetics, said in a release. “The data from the ALCANZA trial provide compelling evidence that CTCL patients treated with Adcetris had superior outcomes across all 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. These data demonstrate the potential of Adcetris to change the treatment landscape of CTCL.”
The open-label, randomized phase 3 ALCANZA trial evaluated the single-agent brentuximab vedotin versus a control arm of investigator’s choice of methotrexate or bexarotene in patients with CD30-positive CTCL.
The trial achieved its primary endpoint, which demonstrated that patients in the brentuximab vedotin arm achieved a highly statistically significant improvement in the rate of objective response lasting at least 4 months (ORR4) compared with the control arm. ORR4 was 56.3% in the brentuximab vedotin arm and 12.5% in the control.
Secondary endpoints included complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment. These key endpoints were all highly statistically significant in favor of the brentuximab vedotin arm, according to the release.
The most common adverse events of any grade were peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritus, pyrexia, decreased appetite, and hypertriglyceridemia.
“Today’s publication of the positive results of the ALCANZA trial is another milestone for our brentuximab vedotin clinical program,” Dirk Huebner, MD, executive medical director of the Oncology Therapeutic Area Unit at Takeda Pharmaceutical, said in a 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.
“We are encouraged by the data we’ve seen from our robust ongoing clinical investigation program of Adcetris in CD30-positive lymphomas, and are committed to bringing this important therapy to patients.”
Takeda will begin submitting data from the trial in 2017 to regulatory agencies in its territories. Seattle Genetics plans to submit data as part of a supplemental Biologics License Application to the FDA in mid-2017, according to the release.
The FDA granted Breakthrough Therapy Designation to Adcetris to treat the most common subtypes of CTCL, mycosis fungoides, and primary cutaneous anaplastic large cell lymphoma.
UPDATE: Today, Seattle Genetics submitted a supplemental BLA to the FDA for brentuximan vedotin to treat CTCL.