14 Aug Lymphoma Drug Shows Promising Results in Phase 3 Trial
MedicalResearch.com Interview with:
Dirk Huebner, MD
Senior Medical Director
Oncology Therapeutic Area Unit
Takeda Pharmaceutical Company
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. Cutaneous T-cell lymphoma, also known as CTCL, is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis.
ADCETRIS® (brentuximab vedotin) is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50 percent of patients with CTCL. The Phase 3 ALCANZA trial compared the use of single-agent ADCETRIS to a control arm of investigator’s choice of standard therapies, methotrexate or bexarotene, in 131 patients with CD30-expressing CTCL who received prior systemic or radiation therapy.
The study met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4). The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm.
MedicalResearch.com: What should readers take away from your report?
Response: The results from the completed ALCANZA trial are both remarkable and clinically meaningful. If ADCETRIS is approved in this new indication, it may offer a novel treatment option for CTCL patients, where there is a significant need for additional, effective treatment options.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Targeting cells that express CD30 represents a promising therapeutic avenue, and ADCETRIS could potentially be combined with other innovative treatment modalities for the benefit of appropriate patients. Currently, ADCETRIS is being evaluated broadly in more than 45 ongoing clinical trials.
MedicalResearch.com: Is there anything else you would like to add?
Response: We hope to present data from this study at this year’s American Society of Hematology (ASH) annual meeting in San Diego, California.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on August 14, 2016 by Marie Benz MD FAAD