Seattle Genetics, Inc.
(Nasdaq: SGEN) today highlighted multiple ADCETRIS (brentuximab vedotin) data presentations at the 12
International Conference on Malignant Lymphoma (ICML) being held June 19-22, 2013 in Lugano, Switzerland. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL and conditional marketing authorization by the European Commission in October 2012 for relapsed or refractory HL and relapsed or refractory sALCL. Four oral and two poster presentations at ICML illustrated the broad clinical development program for ADCETRIS, including oral presentations describing the ongoing global phase 3 ECHELON-2 trial in frontline mature T-cell lymphoma (MTCL) and data from a phase 2 trial in patients with relapsed MTCL. In addition, an oral presentation included the first report of data from an investigator-sponsored trial evaluating ADCETRIS in first-relapse HL patients as part of a pre-autologous stem cell transplant regimen.
“With last year’s European conditional marketing authorization supporting the use of ADCETRIS as a treatment for patients with relapsed HL and sALCL, this meeting provides us with an opportunity to share important ADCETRIS data with the international physician and patient community as we evaluate ADCETRIS in additional disease settings,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. “ADCETRIS is being evaluated for the treatment of CD30-positive malignancies in more than 20 ongoing clinical trials, including three global phase 3 trials. We look forward to the ongoing presentation of important data at medical meetings such as ICML, demonstrating the broad therapeutic potential of ADCETRIS.”
PET-adapted Sequential Therapy with Brentuximab Vedotin and Augmented-ICE in Relapsed and Refractory Hodgkin Lymphoma (Abstract #141, oral session on Saturday, June 22, 2013 at 8:50 AM CET)
In an ongoing investigator-sponsored phase 2 clinical trial, patients with relapsed or refractory HL have been enrolled to determine whether ADCETRIS can replace the combination chemotherapy regimen ifosfamide, carboplatin and etoposide (ICE) or be used in sequential administration with ICE to increase the rate of pre-transplant FDG-PET normalization (PET-N), which is an important prognostic factor for patients undergoing autologous stem cell transplant (ASCT). At the time of data analysis, 40 patients had been enrolled and 33 patients had completed the treatment program. Key findings presented by Dr. Alison Moskowitz from Memorial Sloan Kettering Cancer Center include:
- Of 33 evaluable patients, 79 percent obtained a complete remission, including ten patients who achieved PET-N following treatment with ADCETRIS alone and 16 patients who achieved PET-N following the entire treatment program of ADCETRIS sequenced with augmented ICE. All 26 patients underwent ASCT. Of the seven patients who remained PET positive after receiving augmented ICE, one patient underwent an ASCT, five patients received radiation therapy followed by ASCT and one patient received additional chemotherapy.
- Of the 33 evaluable patients, 32 received an ASCT.
- The most common adverse events of any grade were rash (70 percent) and neuropathy (45 percent).
- Enrollment is ongoing. For more information about this trial, visit www.clinicaltrials.gov.
ADCETRIS is not approved for salvage HL patients who are deemed eligible for ASCT.