- Japanese drugmaker Takeda Pharmaceuticals and Seattle Genetics, a Washington-based biotech, said Monday their drug for cutaneous T-cell lymphoma hit its main endpoint in a Phase 3 trial, improving objective response rates compared to methotrexate or bexarotene.
- Benefit of treatment with the drug, called Adcetris, was measured by an atypical endpoint: objective response rate lasting at least four months (ORR4). The Food and Drug Administration okayed use of this endpoint through a special protocol assessment.
- Patients treated with Adcertis saw an ORR4 of 56.3%, compared to 12.5% for patients receiving methotrexate or bexarotene. Adcetris is already approved for third-line (or post stem cell transplantation) treatment of classical Hodgkin lymphoma in the U.S., along with two other indications.
Seattle Genetics CEO Clay Siegall said the company plans to submit a supplemental biologics license assessment to the FDA sometime in the first half of next year for approval of Adcetris in cutaneous T-cell lymphoma (CTCL).
The Phase 3 study included 131 patients with CD-30 expressing CTCL who had received prior radiation therapy. In addition to demonstrating an improvement in ORR4, treatment with Adcetris also showed a benefit in progression-free survival and in reducing the burden of symptoms during treatment, the companies said.
CTCL is a type of non-Hodgkin lymphoma affecting the skin and typically results in red scaly patches and thickened plaques of skin. While these symptoms mirror eczema or dermatitis, the plaques can be accompanied by tumor formation and ulceration.
Existing treatments for CTCL typically have objective response rates from 30% to 45%, according to the company. Adcetris would appear to compare favorably, although its results were measured using an atypical endpoint.
"This is the first Phase 3 randomized 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,” said Siegall.
Takeda and Seattle Genetics are jointly developing Adcetris and split development costs equally, except in Japan. Seattle Genetics has rights to commercialize the drug in the U.S. and Canada, while Takeda has rights elsewhere.