Rare Disease Report

Lancet Publishes Randomized Phase 3 Data for Adcetris in CTCL Patients

JUNE 06, 2017
Mathew Shanley
Earlier today, via a news release, Takeda Pharmaceutical and Seattle Genetics, Inc. announced that data from a Phase 3 clinical trial evaluating Adcetris (brentuximab vedotin) in cutaneous T-cell lymphoma (CTCL) patients were published in Lancet.
The ALCANZA trial is a randomized, open-label Phase 3 study aimed at assessing single-agent Adcetris versus a control arm of investigator’s choice of the standard of care therapies methotrexate or bexarotene in patients with CD30-positive CTCL. The data were previously presented in an oral session at the 58th American Society of Hematology (ASH) annual meeting in December.
Currently not approved for the treatment of CTCL, Adcetris is an antibody-drug conjugate (ADC) focused on CD30, which is expressed on CTCL lesions in approximately 50% of patients with the disease.
Most often present in red, scaly patches or thickened plaques of skin that resemble eczema or dermatitis, CTCL is the most common type of cutaneous lymphoma. The current treatment includes tactics like skin-directed therapies, radiation and systemic therapies. At present, the systemic therapies approved for treatment have determined 30-to-45% objective response rates, with low complete response rates.
“Today’s publication of the positive results of the ALCANZA trial is another milestone for our brentuximab vedotin clinical program. 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,” said Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company.
“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.”
Assessed by an independent review facility, a highly statistically significant improvement in the rate of objective response lasting at least 4 months was seen in the Adcetris treatment arm versus the control arm. Also in favor of the Adcetris arm were key secondary endpoints like highly statistically significant complete response rate, progression-free survival and reduction in the burden of symptoms during treatment.
The most typical adverse events (AE) of any grade include: peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritis, pyrexia, decreased appetite and hypertriglyceridemia.

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