Seagen Inc. (Nasdaq:SGEN) today announced promising efficacy and safety results from Part B of an open-label, phase 2 clinical trial evaluating ADCETRIS® (brentuximab vedotin) in a novel combination with nivolumab, doxorubicin, and dacarbazine (AN+AD) as a frontline treatment for patients with advanced stage classical Hodgkin lymphoma (cHL). Data from this preliminary analysis were presented (Abstract #2454) as part of a poster presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition in Atlanta.
The preliminary results demonstrated a complete response rate of 88 percent (95% CI: 75.9, 94.8) and overall response rate of 93 percent (95% CI: 82.7, 98.0) among 56 patients who had an end of treatment assessment on or prior to the data cutoff date. Patients received up to six cycles of treatment and were evaluated after two cycles of therapy and at the end of treatment. AN+AD was well-tolerated and no new safety signals were observed.
“I am excited about this combination of brentuximab vedotin and nivolumab along with a simplified chemotherapy regimen for the frontline treatment of patients with advanced stage classical Hodgkin lymphoma,” said Hun Ju Lee, M.D., Associate Professor of Medicine, Department of Lymphoma and Myeloma, MD Anderson Cancer Center, Houston. “This combination demonstrated a low incidence of peripheral neuropathy and the absence of febrile neutropenia. What we are learning from our research is that the use of two active targeted agents with distinct and complementary mechanisms of action in the first-line setting shows promising activity and a tolerable safety profile.”
“We are optimistic about novel combination approaches to improve outcomes in patients following a diagnosis of classical Hodgkin lymphoma, and we are encouraged by these data evaluating ADCETRIS plus nivolumab, doxorubicin and dacarbazine as a first-line therapy,” said Roger Dansey, M.D., Chief Medical Officer at Seagen. “We look forward to complete results from this trial and adding to the breadth of evidence for ADCETRIS in the treatment of advanced classical Hodgkin lymphoma.”
Efficacy:
Among 56 patients who had an end of treatment assessment on or prior to the data cutoff date, there was a complete response rate of 88 percent (95% CI: 75.9, 94.8) and overall response rate of 93 percent (95% CI: 82.7, 98.0).
Safety:
The most frequently reported treatment-related treatment-emergent adverse events (AEs) occurring in more than 20 percent of patients who received AN+AD included nausea (65%), fatigue (46%), peripheral sensory neuropathy (39%), alopecia (35%), diarrhea (30%) and constipation (25%).
Immune-mediated AEs were observed in 18 patients (32%) and eight patients (14%) experienced treatment-related treatment-emergent serious AEs.
Two patients (4%) experienced Grade > 3 peripheral neuropathy and no patients discontinued treatment due to peripheral neuropathy. No febrile neutropenia was observed, and there were no Grade 5 adverse events.
See ADCETRIS U.S. Important Safety Information, including Boxed Warning, below.
About the SGN35-027 Clinical Study
SGN35-027 is an ongoing open-label, multiple part, multicenter, phase 2 clinical trial evaluating two brentuximab vedotin treatment combinations in patients with advanced stage classical Hodgkin lymphoma. The trial includes three parts (Parts A, B, and C). Part A includes a combination of brentuximab vedotin and doxorubicin, vinblastine and dacarbazine (A+AVD), while Parts B and C include brentuximab vedotin in combination with nivolumab, doxorubicin, and dacarbazine (AN+AD). The primary endpoint for Part A is the proportion of patients with treatment-emergent incidence of rate of febrile neutropenia. The primary endpoint f...
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