Takeda And Seattle Genetics Announce Lancet Publication Of Phase III Alcanza Clinical Trial Data Of Adcetris (Brentuximab Vedotin) For CD30-Positive Cutaneous T-Cell Lymphoma
CAMBRIDGE, Mass. & OSAKA, Japan & BOTHELL, Wash.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502) and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that data from the randomized Phase 3 ALCANZA clinical trial evaluating ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL) were published in the journal Lancet. Data were previously presented in an oral session at the 58th American Society of Hematology (ASH) annual meeting in December 2016. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30 which is expressed on CTCL lesions in approximately 50 percent of patients with the disease. ADCETRIS is currently not approved for the treatment of CTCL.
“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.”
“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,” said Bob Lechleider, M.D., Senior Vice President, Clinical Development of Seattle Genetics. “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. These data demonstrate the potential of ADCETRIS to change the treatment landscape of CTCL.”
ALCANZA is a randomized, open-label Phase 3 study designed to evaluate 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 manuscript highlights data from the trial which achieved its primary endpoint with the ADCETRIS treatment arm demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4) versus the control arm as assessed by an independent review facility. ORR4, as assessed by Global Response Score, was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm (p-value <0.0001). Key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in the burden of symptoms during treatment (Skindex-29), were all highly statistically significant in favor of the ADCETRIS arm. The safety profile associated with ADCETRIS from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include: peripheral neuropathy, nausea, diarrhea, fatigue, vomiting, alopecia, pruritis, pyrexia, decreased appetite and hypertriglyceridemia.
Based on the study results, Takeda plans to begin to submit data from the ALCANZA trial to regulatory agencies in its territories in 2017. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to ADCETRIS for the treatment of the most common subtypes of CTCL, mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL). Seattle Genetics plans to submit these data as part of a supplemental Biologics License Application to the FDA in mid-2017. The ALCANZA trial received a Special Protocol Assessment (SPA) agreement from the FDA and scientific advice from the European Medicines Agency (EMA).