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seattle genetics inc (SGT) Snapshot

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€25.81
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02/26/14 - €40.07
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3.3B
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123.9M
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Current Stock Chart for SEATTLE GENETICS INC (SGT)

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seattle genetics inc (SGT) Details

Seattle Genetics, Inc., a biotechnology company, develops and commercializes antibody-based therapies for the treatment of cancer. The company is developing antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Its lead product, ADCETRIS (brentuximab vedotin), is an ADC that has been approved in approximately 35 countries, including the United States, Canada, Japan, and members of the European Union for relapsed Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell lymphoma (sALCL) in collaboration with Takeda Pharmaceutical Company Limited. The company also evaluates approximately 30 ongoing clinical trials, including Phase III trials for post-transplant HL relapse prevention, relapsed CD30-positive cutaneous T-cell lymphoma, frontline HL in combination with chemotherapy, and frontline CD30-positive mature T-cell lymphoma in combination with chemotherapy, as well as in Phase I and II studies in various lymphoma and non-lymphoma indications. In addition, it is developing a pipeline of other clinical-stage ADC programs, including SGN-CD19A for CD19A-positive hematologic malignancies, SGN-CD33A in CD33-positive acute myeloid leukemia, SGN-LIV1A in LIV-1-positive breast cancer, ASG-22ME for treatment of Nectin-4-positive solid tumors, and ASG-15ME for treatment of SLITRK6-positive bladder cancer. The company has collaborations for its ADC technology with various biotechnology and pharmaceutical companies, including AbbVie, Agensys, Bayer, Genentech, GlaxoSmithKline, and Pfizer. Seattle Genetics, Inc. was founded in 1997 and is headquartered in Bothell, Washington.

582 Employees
Last Reported Date: 02/28/14
Founded in 1997

seattle genetics inc (SGT) Top Compensated Officers

Co-Founder, Chairman, Chief Executive Officer...
Total Annual Compensation: $724.4K
Chief Financial Officer and Principal Account...
Total Annual Compensation: $397.0K
Chief Operating Officer and Corporate Secreta...
Total Annual Compensation: $456.3K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $383.3K
Executive Vice President of Commercial
Total Annual Compensation: $309.3K
Compensation as of Fiscal Year 2013.

seattle genetics inc (SGT) Key Developments

Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited Announces Data from Phase III Lymphoma Trial

Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited have announced data from Phase III AETHERA trial, which demonstrates that Hodgkin lymphoma, or HL, patients at risk of relapse following an autologous stem cell transplant, or ASCT, who received ADCETRIS, or brentuximab vedotin, as consolidation therapy immediately after ASCT had significant improvement in progression-free survival, or PFS, compared to patients who received placebo. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS has been approved in more than 45 countries for the treatment of relapsed or refractory HL and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is currently not approved in the AETHERA treatment setting. The Phase III AETHERA trial was designed to evaluate the potential of single agent ADCETRIS to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival (OS), safety and tolerability. Eligible patients must have had a history of refractory HL, have relapsed within one year from receiving frontline chemotherapy and/or have had disease outside of the lymph nodes at the time of pre-ASCT relapse. These factors are consistently reported to be associated with poor prognosis after transplant. Patients received ADCETRIS or placebo every three weeks for up to approximately one year. This international multi-center trial was conducted at 78 sites in the US, Eastern and Western Europe and Russia. A total of 329 HL patients at risk of relapse were enrolled, including 165 on the ADCETRIS arm and 164 on the placebo arm. Patients received a median of 15 cycles of treatment on both arms, with an average of 12 cycles on the ADCETRIS arm and 11 cycles on the placebo arm. The trial achieved its primary endpoint and demonstrated a significant increase in PFS per independent review facility (IRF), with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS per IRF was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate per IRF was 63% in the ADCETRIS arm compared to 51% in the placebo arm. Per investigator, the hazard ratio was 0.50. The two-year PFS rate per investigator was 65% in the ADCETRIS arm compared to 45% in the placebo arm. The median PFS per investigator has not yet been reached for patients who received ADCETRIS versus 16 months for patients who received placebo. Very few progression events have been observed beyond two years. The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease. Patients in both arms of the study who experienced disease progression received a variety of subsequent therapies. In the ADCETRIS arm, only eight of 51 patients (16%) receiving subsequent therapy were treated with ADCETRIS following relapse. In the placebo arm, 72 of 85 patients (85%) receiving subsequent therapy were treated with single agent ADCETRIS. Twenty-four patients in the placebo arm and 13 patients in the ADCETRIS arm received stem cell transplant as subsequent therapy, the majority of which were allogeneic transplants. OS data are immature, and no statistically significant difference in OS has been observed between the treatment arms (hazard ratio 1.15; p-value=0.62). A further analysis of overall survival is planned in 2016. The most common adverse events in the ADCETRIS arm were peripheral sensory neuropathy (56%), neutropenia (35%), upper respiratory tract infection (26%), fatigue (24%) and peripheral motor neuropathy (23%). The most common adverse events in the placebo arm were upper respiratory tract infection (23%), fatigue (18%) peripheral sensory neuropathy (16%), cough (16%) and neutropenia (12%). Eighty-five% of patients with peripheral neuropathy on the ADCETRIS arm had resolution or improvement in symptoms with a median time to improvement of 23.4 weeks. Grade 3 or higher adverse events in the ADCETRIS arm included neutropenia, peripheral sensory neuropathy, peripheral motor neuropathy, nausea, fatigue and diarrhea. Grade 3 or higher adverse events in the placebo arm included neutropenia, fatigue, peripheral motor neuropathy, diarrhea and peripheral sensory neuropathy. No Grade 4 peripheral neuropath y events occurred. One death occurred within 30 days of ADCETRIS treatment from treatment-related acute respiratory distress syndrome (ARDS) associated with pneumonitis. One death occurred on the ADCETRIS arm at Day 40 from ARDS following an episode of treatment-related acute pancreatitis, which had resolved at the time of death. Submission of safety data from the AETHERA trial to the FDA is a post-marketing requirement that Seattle Genetics will fulfill in its planned supplemental BLA. Takeda plans to submit data from the AETHERA trial to regulatory agencies in its territories.

Seattle Genetics Presents Data from SGN-CD19A Antibody-Drug Conjugate at Ash Annual Meeting

Seattle Genetics Inc. presented data from two ongoing phase 1 clinical trials evaluating SGN-CD19A, an antibody-drug conjugate (ADC) in development for the treatment of B-cell malignancies, including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL), at the 56thAmerican Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Francisco, CADecember 6-9, 2014. SGN-CD19A is an ADC targeting CD19, a protein expressed uniformly on almost all B-cell malignancies. The ADC is designed to be stable in the bloodstream and release its cytotoxic agent upon internalization into CD19-expressing cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity. Data were reported from 52 patients with relapsed or refractory NHL, including 45 patients with diffuse large B-cell lymphoma (DLBCL), three patients with grade 3 follicular lymphoma and four patients with mantle cell lymphoma. Of the 52 patients, 30 patients (58%) were refractory to their last therapy and 22 patients (42%) were relapsed. Fourteen patients (27%) had received a prior autologous stem cell transplant. The median age of patients was 65 years. The primary endpoints of the ongoing clinical trial are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD19A. In addition, the trial is evaluating antitumor activity, pharmacokinetics, progression-free survival and overall survival. In this dose-escalation study, patients receive SGN-CD19A on an every three week schedule. Patients with stable disease or better are eligible to continue treatment with SGN-CD19A. Key findings in a poster presentation by Craig Moskowitz, M.D.Clinical Director, Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center, include: The maximum tolerated dose was not exceeded after escalating to 6 milligrams per kilogram (mg/kg) every three weeks. In addition, evaluation of an every six week dosing schedule is underway and enrollment is ongoing. Of the 51 patients evaluable for response, 18 patients (35%) achieved an objective response, including 10 patients (20%) with a complete remission and eight patients (16%) with a partial remission. Thirteen patients (25%) achieved stable disease and 20 patients (39%) had disease progression. Antitumor activity appeared to be higher in relapsed patients. Of the 22 relapsed patients, 12 patients (55%) achieved an objective response, including seven patients (32%) with a complete remission and five patients (23%) with a partial remission. Six patients (27%) achieved stable disease and four patients (18%) had disease progression. The most common adverse events of any grade occurring in more than 25% of patients were blurred vision (60%), dry eye (46%), fatigue (38%), constipation (33%) and keratopathy (31%). Most ocular symptoms were Grade 1/2. The majority of patients with Grade 3 or 4 ocular symptoms and/or corneal findings experienced improvement and/or resolution at last follow-up. Ocular symptoms and corneal findings were managed with steroid eye drop treatment and dose modifications. In this phase 1 trial, adult and pediatric patients with relapsed or refractory B-lineage ALL and highly aggressive lymphoma, including B-cell lymphoblastic lymphoma (LBL) and Burkitt lymphoma were enrolled. Data were reported from 51 adult patients. The median age of adult patients was 43 years and the median number of prior systemic therapies was two, with 14 patients (27%) having received a prior allogeneic stem cell transplant. The primary endpoints of the ongoing clinical trial are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD19A. In addition, the trial is evaluating antitumor activity, pharmacokinetics, progression-free survival and overall survival. In this dose-escalation study, patients received SGN-CD19A at either 0.3 to 2.3 mg/kg weekly or 4 to 6 mg/kg every three weeks. Key findings presented by Amir Fathi, M.D., Massachusetts General Hospital, include: At the time of data analysis, dose escalation is ongoing. Safety analysis included data from 51 patients, including 18 patients treated every three weeks and 33 patients treated weekly. Of the 14 ALL and LBL adult patients evaluable for response treated every three weeks, five patients (36%) achieved an objective response, including four patients (29%) with a complete remission and one patient (seven%) with a partial remission. Eight patients (57%) achieved stable disease and one patient (seven%) had disease progression. Of the 29 ALL and LBL adult patients evaluable for response treated with weekly dosing, six patients (20%) achieved an objective response, including five patients (17%) with a complete remission and one patient (three%) with a partial remission. Ten patients (34%) achieved disease stabilization and 13 patients (45%) had disease progression. The most common adverse events of any grade occurring in 25% or more of adult patients treated every three weeks (18 patients) and weekly (33 patients), respectively, were fever (56 and 55%), chills (33 and 56%), fatigue (33 and 55%), headache and nausea (28 and 55%), blurred vision (39 and 36%), vomiting (28 and 42%) and febrile neutropenia (28 and 33%). Symptoms related to keratopathy were reported in 27 patients. All symptoms were Grade 1/2; no Grade 3 symptoms were reported. The most common symptoms were blurred vision, dry eye and photophobia. Grade 3 or 4 keratopathy was reported in 10 patients and the majority had experienced improvement and/or resolution at last follow-up. Ocular symptoms and corneal findings were managed with steroid eye drop treatment and dose modifications. Prophylactic eye drops were instituted early in the trial and appear to reduce the severity of corneal events in the weekly treatment schedule.

Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited Report Phase 3 AETHERA Clinical Trial Data from ADCETRIS(R) (Brentuximab Vedotin)

Seattle Genetics Inc. and Takeda Pharmaceutical Company Limited reported data demonstrating that Hodgkin lymphoma (HL) patients at risk of relapse following an autologous stem cell transplant (ASCT) who received ADCETRIS (brentuximab vedotin) as consolidation therapy immediately after ASCT had significant improvement in progression-free survival (PFS) compared to patients who received placebo (median of 43 months versus 24 months, respectively; hazard ratio=0.57; p-value=0.001). The data from the AETHERA trial were featured at the 56th American Society of Hematology (ASH) Annual Meeting press program and will be presented in an oral session on December 8, 2014. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS has been approved in more than 45 countries for the treatment of relapsed or refractory HL and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is currently not approved in the AETHERA treatment setting. The AETHERA Trial: Results of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Brentuximab Vedotin in the Treatment of Patients at Risk of Progression Following Autologous Stem Cell Transplant for Hodgkin Lymphoma (Abstract #673, oral presentation at 4:30 p.m. PT on December 8, 2014 at the Moscone Center West Building, 3001-3003-3014-3016). The Phase 3 AETHERA trial was designed to evaluate the potential of single agent ADCETRIS to extend PFS post-ASCT in patients with HL who have at least one risk factor for progression. In addition to the primary endpoint of PFS, secondary endpoints included overall survival (OS), safety and tolerability. Eligible patients must have had a history of refractory HL, have relapsed within one year from receiving frontline chemotherapy and/or have had disease outside of the lymph nodes at the time of pre-ASCT relapse. These factors are consistently reported to be associated with poor prognosis after transplant. Patients received ADCETRIS or placebo every three weeks for up to approximately one year. This international multi-center trial was conducted at 78 sites in the United States, Eastern and Western Europe and Russia. A total of 329 HL patients at risk of relapse were enrolled, including 165 on the ADCETRIS arm and 164 on the placebo arm. Patients received a median of 15 cycles of treatment on both arms, with an average of 12 cycles on the ADCETRIS arm and 11 cycles on the placebo arm. Key findings, which were highlighted by Dr. Moskowitz, include: The trial achieved its primary endpoint and demonstrated a significant increase in PFS per independent review facility (IRF), with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS per IRF was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate per IRF was 63% in the ADCETRIS arm compared to 51% in the placebo arm; Per investigator, the hazard ratio was 0.50. The two-year PFS rate per investigator was 65% in the ADCETRIS arm compared to 45% in the placebo arm. The median PFS per investigator has not yet been reached for patients who received ADCETRIS versus 16 months for patients who received placebo. Very few progression events have been observed beyond two years; The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease; Patients in both arms of the study who experienced disease progression received a variety of subsequent therapies. In the ADCETRIS arm, only eight of 51 patients (16%) receiving subsequent therapy were treated with ADCETRIS following relapse. In the placebo arm, 72 of 85 patients (85%) receiving subsequent therapy were treated with single agent ADCETRIS. Twenty-four patients in the placebo arm and 13 patients in the ADCETRIS arm received stem cell transplant as subsequent therapy, the majority of which were allogeneic transplants.

 

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