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February 6, 2013
09:02 EDTSGENSeattle Genetics initiates two Phase I trials of SGN-CD19A
Seattle Genetics announced the initiation of two phase I clinical trials of SGN-CD19A, one for patients with B-cell acute lymphoblastic leukemia and one for patients with B-cell non-Hodgkin lymphomas. SGN-CD19A utilizes Seattle Genetics’ industry-leading antibody-drug conjugate technology. The trials are designed to assess the safety and antitumor activity of SGN-CD19A, an ADC targeted to CD19. The studies are phase I, open-label, dose-escalation clinical trials. The primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD19A. In addition, the trials will evaluate antitumor activity, pharmacokinetics, progression-free survival and overall survival. One trial will enroll adult and pediatric patients with relapsed or refractory B-cell ALL, as well as patients with Burkitt lymphoma or leukemia or B-cell lymphoblastic lymphoma. The dose escalation portion of the study is designed to evaluate both weekly and every three week schedules and will enroll approximately 80 patients at multiple centers in the United States. A second trial will enroll patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and mantle cell lymphoma. The dose escalation portion of the trial will evaluate SGN-CD19A administered every three weeks and will enroll approximately 25 patients at multiple centers in the United States.
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December 18, 2014
09:03 EDTSGENSeattle Genetics initiates Phase 1b trial of SGN-CD33A
Seattle Genetics announced initiation of a phase 1b clinical trial of SGN-CD33A in combination with standard of care chemotherapy, including cytarabine and daunorubicin, for patients with newly diagnosed acute myeloid leukemia. The trial will also evaluate SGN-CD33A in the consolidation setting for AML, both in combination with cytarabine and as a single-agent maintenance regimen. SGN-CD33A is a novel antibody-drug conjugate targeted to CD33 utilizing Seattle Genetics’ newest technology. CD33 is expressed on most AML cells regardless of subtype, cytogenetic abnormality or underlying mutational heterogeneity. SGN-CD33A is also under evaluation in an ongoing phase 1 dose escalation trial as a single-agent or in combination with hypomethylating agents for the treatment of patients who have relapsed AML or have declined intensive frontline therapy. The study is a phase 1b, open-label, multi-center, dose-escalation clinical trial designed to evaluate SGN-CD33A administered in combination with frontline standard of care regimens for induction (cytarabine and daunorubicin) and/or consolidation. In addition, the study will evaluate single-agent SGN-CD33A as a maintenance regimen. The primary endpoints are determination of the maximum tolerated dose and safety profile of SGN-CD33A in these settings. In addition, the trial will evaluate anti-leukemic activity, pharmacokinetics, progression-free survival and overall survival. The phase 1b trial will enroll approximately 90 patients at multiple centers in the United States.
December 8, 2014
19:42 EDTSGENSeattle Genetics says Adcetris 'demonstrates antitumor activity'
Seattle Genetics highlighted two separate Adcetris data presentations in relapsed/refractory and frontline diffuse large B-cell lymphoma, or DLBCL, at the 56th American Society of Hematology, or ASH, Annual Meeting and Exposition. Adcetris is an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma, anaplastic large cell lymphoma and several other types of non-Hodgkin lymphoma. Seattle Genetics CEO Clay Siegall said, “The updated phase 2 data at ASH demonstrate encouraging activity of Adcetris in relapsed/refractory DLBCL, even when CD30 is undetectable by standard immunohistochemistry methods. In addition, our data show that Adcetris can be safely combined with RCHOP in the frontline setting with a strong complete remission rate in high-intermediate and high-risk patients. The activity observed supports our plans to initiate a randomized phase 2 clinical trial of Adcetris for relapsed CD30-positive DLBCL patients during 2015 and to pursue possible frontline DLBCL combination trials."
19:41 EDTSGENSeattle Genetics says planning phase 1b combination trial for SGN-CD33A
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10:04 EDTSGENSeattle Genetics highlights 'encouraging' long-term outcomes in Phase 1 trial
Seattle Genetics highlighted multiple ADCETRIS data presentations in frontline and salvage Hodgkin lymphoma at the 56th American Society of Hematology Annual Meeting and Exposition taking place in San Francisco, CA, December 6-9. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma, a type of T-cell lymphoma. Data highlighted in oral sessions include encouraging long-term outcomes from a phase 1 trial evaluating ADCETRIS in combination with AVD chemotherapy in frontline HL, as well as strong activity evaluating ADCETRIS combination therapy in second-line HL and ADCETRIS monotherapy or combination therapy in frontline HL patients age 60 and older. In addition, encouraging data from multiple investigator-sponsored trials were featured in oral and poster sessions evaluating ADCETRIS in frontline and salvage HL and in non-Hodgkin lymphoma settings.
08:33 EDTSGENSeattle Genetics should be bought on weakness, says RBC Capital
RBC Capital believes that Seattle Genetics' shares could be under pressure today due to questions around its AETHERA data and the checkpoint inhibitor efficacy of its ADCETRIS drug. However, the firm says that other issues are more important over the longer term, including the efficacy of ADCs as a cancer treatment, the emergence of other pipeline products and therapeutic approaches, and efficient development pathways to the market. The firm keeps a $48 price target and Outperform rating on Seattle Genetics.
December 7, 2014
13:23 EDTSGENSeattle Genetics, Takeda announce four-year data from ADCETRIS trial
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12:50 EDTSGENSeattle Genetics presents data from SGN-CD19A antibody-drug conjugate
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12:44 EDTSGENSeattle Genetics, Takeda report Phase 3 AETHERA trial data from Adcetris
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