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|Millennium and Takeda Report Data from Phase I Trial of ADCETRIS® (Brentuximab Vedotin) in Newly Diagnosed Hodgkin Lymphoma at ASH Annual Meeting|
– Safety and Response Data Support Currently Enrolling Phase III Trial Evaluating ADCETRIS plus AVD Chemotherapy in Patients with Newly Diagnosed Hodgkin Lymphoma –
– ADCETRIS in Combination with AVD Chemotherapy Showed a 96 Percent Complete Remission Rate in Patients with Newly Diagnosed Advanced Hodgkin Lymphoma –
Atlanta, GA – December 10, 2012 –Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of patients with newly diagnosed advanced stage Hodgkin lymphoma (HL). These data were presented at the 54th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 8-11, 2012 in Atlanta, GA. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS is currently not approved for use in the treatment of newly diagnosed HL.
In this open-label, multicenter trial, cohorts of patients received escalating doses of ADCETRIS ranging from 0.6 mg/kg to 1.2 mg/kg every two weeks concomitantly with ABVD (adriamycin, bleomycin, vinblastine and dacarbazine) or a dose of 1.2 mg/kg every two weeks concomitantly with AVD, which removes bleomycin from the regimen. The trial was designed to establish the safety profile and maximum tolerated dose when adding ADCETRIS to ABVD or AVD. Antitumor activity was assessed as a secondary endpoint.
Pulmonary toxicity was seen in the ADCETRIS plus ABVD arm of this study. The concomitant administration of ADCETRIS and bleomycin is contraindicated. ADCETRIS combined with AVD was generally well tolerated. To date, no pulmonary toxicity events have been observed in the ADCETRIS plus AVD cohorts.
Results from the ADCETRIS plus AVD arm of this phase I clinical trial showed 24 of 25 patients (96 percent) had a complete remission (CR), while 21 of 22 (95 percent) of patients treated with ADCETRIS plus ABVD had a CR.
“For decades researchers have strived to find ways to improve the front-line HL treatment strategy by enhancing the activity of traditional chemotherapy regimens while reducing toxicities and long-term side effects of such regimens,” said Stephen Ansell, M.D., Ph.D., Medical Oncologist. “An unmet medical need remains for patients in the front-line HL setting. With a complete response rate of 96 percent and a generally manageable safety profile, data from this trial support further evaluation of ADCETRIS administered concomitantly with AVD.”
Front-line Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma (Abstract #798)
Fifty-one patients were enrolled in the phase I study and 47 were evaluable for response at trial completion. The 47 evaluable patients included 25 in the ADCETRIS plus AVD cohorts and 22 in the ADCETRIS plus ABVD cohorts. All patients were previously untreated with Stage IIA bulky disease or Stage IIB-IV Hodgkin lymphoma. The median age of patients across all cohorts of the trial was 33 years. Key findings, which were highlighted in an oral presentation by Dr. Stephen Ansell, included:
Millennium and Seattle Genetics have initiated a phase III clinical trial in patients with newly diagnosed advanced stage HL. The randomized trial is comparing progression-free survival in patients receiving ADCETRIS in combination with AVD to patients receiving ABVD alone. For more information about the trial, please visit www.clinicaltrials.gov.
ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):
ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL).
ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2011 for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.
Seattle Genetics and Millennium are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.
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