The Phase 3 ALCANZA clinical trial into the drug brentuximab vedotin (Adcetris) has posted positive results, Takeda Pharmaceutical and Seattle Genetics have announced.
The drug, which is for the treatment of cutaneous T-cell lymphoma (CTCL), met its primary endpoint, demonstrating a highly statistically significant improvement in the rate of objective response (ORR4) lasting at least four months. The randomised trial compared the use of single-agent brentuximab vedotin 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 results of the ALCANZA trial demonstrated that treatment with Adcetris resulted in a highly statistically significant improvement in the ORR4 versus the control arm as assessed by an independent review committee. The ORR4 was 56.3% in the Adcetris arm compared to 12.5% in the control arm. The key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in the burden of symptoms during treatment, were all highly statistically significant in favour of the Adcetris arm. The safety profile associated with Adcetris from the ALCANZA trial was generally consistent with the existing prescribing information.
Dirk Huebner, M.D., Executive Medical Director, Oncology Therapeutic Area Unit, Takeda Pharmaceutical Company, said: “These remarkable, clinically meaningful results from the completed ALCANZA trial represent an important milestone for the Adcetris program. If this new indication is approved by regulatory authorities, Adcetris may offer a novel treatment option for CTCL patients.
“We are excited by the data, which showed a significant improvement in the primary endpoint of ORR4 and all key secondary endpoints, along with a manageable safety profile. This outcome further establishes our commitment to patients living with CD30-expressing disease, and we look forward to sharing these data with regulatory authorities globally.”
Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics, 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 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.
“We anticipate reporting more complete ALCANZA data at the ASH annual meeting in December and intend to submit a supplemental Biologics License Application to the FDA in the first half of 2017 for approval in this setting.”