Day: June 7, 2017

ADCETRIS is an antibody-drug conjugate directed to CD30 which is expressed on CTCL lesions in approximately 50 percent of patients with the disease

Based on the study results, Takeda plans to begin to submit data from the ALCANZA trial to regulatory agencies in its territories in 2017.

#Takeda (TKPYY) and #SeattleGenetics (SGEN) announced that data from the randomized Phase 3 ALCANZA clinical trial evaluating ADCETRIS in patients with cutaneous T-cell #lymphoma were published in the journal #Lancet.

Lymphoma is the most common blood cancer. The two main forms of lymphoma are Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Lymphoma occurs when cells of the immune system called lymphocytes, a type of white blood cell, grow and multiply uncontrollably. Cancerous lymphocytes can travel to many parts of the body, including the lymph nodes, spleen, bone marrow, blood, or other organs, and form a mass called a tumor. The body has two main types of lymphocytes that can develop into lymphomas: B-lymphocytes (B-cells) and T-lymphocytes (T-cells).

Data were previously presented in an oral session at the 58th American Society of Hematology annual meeting in December 2016.

#ADCETRIS is an antibody-drug conjugate 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.

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.

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. FDA granted Breakthrough Therapy Designation to ADCETRIS for the treatment of the most common subtypes of CTCL, mycosis fungoides and primary cutaneous anaplastic large cell lymphoma .

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 agreement from the FDA and scientific advice from the European Medicines Agency.