Interim data released on phase I Adcetris trial
Seattle Genetics and Millennium, the Takeda oncology company, released interim results from 32 patients treated to date in a phase I clinical trial of Adcetris (brentuximab vedotin) administered in combination or sequentially with chemotherapy for the treatment of newly diagnosed systemic anaplastic large cell lymphoma (sALCL) and other CD30-positive mature T-cell lymphoma patients.
Data was reported from 32 previously untreated patients, including 12 who received the sequential regimen (CHOP) and 20 who received the concurrent regimen (CH-P).
Among 20 patients treated with the concurrent regimen, all five patients (100%) who had completed the full course of six cycles of multi-agent induction treatment and were evaluable for response at the time of data analysis achieved a complete remission (CR). All five evaluable patients had sALCL. The remaining 15 patients were not yet evaluable for response. The recommended dose of Adcetris in combination with CH-P is 1.8mg/kg every three weeks.
All 12 patients (100%) treated with the sequential regimen achieved an objective response after two cycles of single-agent Adcetris, including four patients (33%) with a CR and eight patients (67%) with a partial remission (PR). All 12 evaluable patients had sALCL. At the time of data analysis, six of these 12 patients had completed six subsequent cycles of CHOP and were evaluable for response. Of these six evaluable patients, four patients (67%) achieved a CR and two patients (33%) achieved a PR. Five remaining patients were not yet evaluable for response. One patient discontinued treatment during CHOP chemotherapy due to progressive disease, after achieving a PR with two cycles of Adcetris.
“The interim data from this phase I clinical trial suggest that Adcetris has the potential to play an important role in advancing the treatment of newly diagnosed T-cell lymphoma patients, and continued investigation of ADCETRIS in these patients is warranted,” said Dr. Michelle Fanale, assistant professor in the department of lymphoma/myeloma, division of cancer medicine at The University of Texas MD Anderson Cancer Center.
The primary endpoints of the trial are dose-limiting toxicities, safety and tolerability of Adcetris when combined or used sequentially with multi-agent front-line chemotherapy regimens. The secondary endpoints are investigator assessment of response, progression-free survival (PFS) and overall survival (OS).
A phase III clinical trial of Adcetris in CD30-positive mature T-cell lymphoma patients, including sALCL, is planned to compare PFS in patients receiving Adcetris in combination with CH-P to patients receiving CHOP alone.