Takeda Pharmaceutical and Seattle Genetics have reported positive results from the Phase III ALCANZA clinical trial of Adcetris to treat cutaneous T-cell lymphoma (CTCL).
Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) composed of an anti-CD30 monoclonal antibody fused by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), using Seattle Genetics’ patented technology.
It uses a linker system that releases MMAE into CD30-expressing tumour cells, while remaining stable in the bloodstream itself.
The randomised, open-label, Phase III ALCANZA trial has been designed to compare the use of single-agent Adcetristo the standard therapies such as methotrexate or bexarotene.
It involved 131 patients with CD30-expressing CTCL who were previously treated with systemic or radiation therapy.
The trial was primarily focused to determine improvement in the rate of objective response lasting at least four months (ORR4), while the secondary endpoints were to evaluate a complete response rate, progression-free survival and reduced symptoms during treatment.
Results displayed greater improvement in the ORR4, following the administration of ADCETRIS compared to the standard therapies.
The trial had also met its secondary endpoint with a safety profile maintained during the ALCANZA trial.
Seattle Genetics president and CEO Clay Siegall said: “Cutaneous T-cell lymphoma is a debilitating, disfiguring and painful disease, and there is a significant need for additional effective treatment options with meaningful durable responses.
“This is the first Phase III randomised trial in CTCL versus an active control to read out, and we are thrilled to have successfully demonstrated the positive impact of using Adcetris for patients enrolled in this study.”
The results have prompted the companies to submit a supplemental Biologics License Application of Adcetristo to the US Food and Drug Administration (FDA) next year.