Key Developments: Seattle Genetics Inc (SGEN.O)
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Latest Key Developments (Source: Significant Developments)
Seattle Genetics Inc Announces Data From ASG-5ME Phase I Clinical Trial For Pancreatic Cancer
Seattle Genetics Inc announced that it presented interim results from a phase I clinical trial evaluating ASG-5ME for the treatment of metastatic pancreatic ductal adenocarcinoma (PDA) at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers Symposium being held January 24-26, 2013 in San Francisco, CA. ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen and is being co-developed by Seattle Genetics and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of solid tumors. The phase I data from the ASG-5ME clinical trial in advanced pancreatic cancer identified the maximum tolerated dose (MTD) for weekly administration, demonstrated tolerability and provided preliminary evidence for antitumor activity. Key findings included: The MTD was identified as 1.2 mg/kg weekly. Of the 35 patients who participated in the trial at the time of analysis, 18 were treated at the MTD. response for the 18 patients treated at 1.2 mg/kg weekly included one patient (6%) who achieved a partial response, six patients (33%) with stable disease and four patients (22%) who had progressive disease. Seven patients (39%) were not evaluable for response. The most common adverse events occurring in patients at the MTD included fatigue (50.0%), vomiting (44.4%), decreased appetite (38.9%), abdominal pain (33.3%) and nausea (33.3%). Full Article
Seattle Genetics Inc Announces Data from Investigator-Sponsored Trials of ADCETRIS(Brentuximab Vedotin) in Cutaneous T-Cell Lymphoma at ASH Annual Meeting
Seattle Genetics Inc announced that results from two ongoing investigator-sponsored phase II clinical trials of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) 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. ADCETRIS has not been approved for use in the treatment of CTCL. The ongoing phase II clinical trial is enrolling CTCL patients with mycosis fungoides (MF) or Sezary syndrome. Twenty patients have been enrolled to date with a median of six prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response and safety. The study was led by principle investigator Dr. Youn H. Kim from Stanford University School of Medicine in Stanford, CA, and was presented in an oral session. Key findings include: Fourteen of 20 patients (70%) achieved an objective response across all stages of disease, including Stage IB, Stage IIB and Stage IVA/B. At the time of analysis, 14 patients had a partial response, one patient had stable disease and four patients had progressive disease. One patient was not evaluable for response. Full Article
Seattle Genetics Inc Announces Data from Phase I Trial of ADCETRIS (Brentuximab Vedotin) in Front-line Mature T-Cell Lymphomas (MTCL)
Seattle Genetics Inc announced results from a phase I clinical trial of ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL). The 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. ADCETRIS is not currently approved for use in the front-line treatment of MTCL. Data were reported from 26 previously untreated patients who received the combination regimen of ADCETRIS plus CHP. Nineteen patients had sALCL, and seven patients had a diagnosis of another mature T- or NK-cell lymphoma. The median age of patients was 56 years. Key findings, which were highlighted in an oral presentation by Dr. Fanale, include: All 26 patients (100%) achieved an objective response after either completing six cycles of combination therapy or at the latest assessment for three patients who discontinued treatment prior to cycle six. Twenty-three patients (88%) achieved a complete remission and three patients (12%) achieved a partial remission. Among 19 sALCL patients, 19 (100%) achieved an objective response, including 16 (84%) with a complete remission. Full Article
Takeda Pharmaceutical Co Ltd's Takeda Oncology Company And Seattle Genetics Inc Initiate Global Phase 3 Clinical Trial Of ADCETRIS In Previously Untreated Advanced Hodgkin Lymphoma
The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, and Seattle Genetics, Inc. announced the initiation of an international phase 3 clinical trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced Hodgkin lymphoma (HL). The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and the trial also received scientific advice from the European Medicines Agency (EMA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. Full Article
Seattle Genetics Inc In Collaboration With Takeda Pharmaceutical Company Limited's The Takeda Oncology Company Receives European Commission Conditional Marketing Authorization For ADCETRIS
Seattle Genetics Inc announced that its collaborator, Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, announced that the European Commission has granted conditional marketing authorization for ADCETRIS (brentuximab vedotin). ADCETRIS was approved for two indications: the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). As a result, under the collaboration Seattle Genetics will receive two milestone payments from Millennium, one for each indication, totaling $25 million. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. The conditional marketing authorization for ADCETRIS is valid in the 27 member states of the European Union (EU) as well as Norway, Liechtenstein and Iceland. Similar to accelerated approval regulations in the United States, conditional marketing authorizations are granted in the EU to medicinal products that fulfill an unmet medical need with a positive benefit/risk assessment and whose immediate availability would result in a significant public health benefit. Full Article
Seattle Genetics Inc Announces Initiation Of Phase Ib Trial Of SGN-75 In Combination With Everolimus For Patients With Renal Cell Carcinoma
Seattle Genetics Inc announced the initiation of a phase Ib clinical trial evaluating SGN-75 in combination with everolimus (Afinitor) for patients with advanced metastatic renal cell carcinoma (RCC). The trial is designed to assess the safety and antitumor activity of SGN-75 in combination with everolimus. The study is a phase Ib, open-label, dose-escalation clinical trial to evaluate the safety and antitumor activity of SGN-75 in combination with everolimus, an mTOR inhibitor, in patients with CD70-positive metastatic RCC. Everolimus is an oral prescription medication used to treat advanced RCC when certain other medicines, such as sunitinib or sorafenib, have not worked. The trial is enrolling patients who have previously been treated with one or two tyrosine kinase inhibitors (TKIs). The primary endpoint of the trial is safety, with key secondary endpoints of clinical response, progression-free survival (PFS) and overall survival (OS). The study is expected to enroll up to 40 patients at multiple centers in the United States. Full Article
Seattle Genetics Highlights Updated Survival Data from ADCETRIS Pivotal Trial In Patients With Relapsed Or Refractory Hodgkin Lymphoma
Seattle Genetics announced updated survival data from a pivotal clinical trial of single-agent ADCETRIS (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5 months. Data, to be presented by Dr. Smith, include: As previously reported, the ORR was 75% (76 of 102 patients), with CRs observed in 33% of patients (n=34). The median OS had not been reached at the time of the analysis. The estimated OS at 24 months was 65%. The median PFS for all patients was 5.6 months. The median PFS for patients achieving a CR was 29 months. Full Article
Seattle Genetics Announces ADCETRIS Clinical Data
Seattle Genetics announced data from several clinical trials of ADCETRIS (brentuximab vedotin). Data demonstrate the activity and tolerability when patients are retreated with ADCETRIS, the activity and tolerability of ADCETRIS in CD30-positive non-Hodgkin lymphomas and CD30 expression from a screening protocol in non-lymphoma malignancies. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. In a phase II trial, patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse were eligible for retreatment. Data were reported from 24 patients treated to date on the study, including 16 with Hodgkin lymphoma (HL) and eight with systemic anaplastic large cell lymphoma (sALCL). Patients had received a median of four prior systemic therapies, including ADCETRIS. Key findings include: Of 23 evaluable patients, 70% (16 of 23) achieved an objective response after retreatment with ADCETRIS, including nine complete remissions (CRs) and seven partial remissions (PRs); Median duration of retreatment objective response was 8.8 months; Among retreated HL patients, nine of 16 (56%) achieved an objective response. Among retreated sALCL patients, seven of eight (88%) achieved an objective response; The most common adverse events were peripheral neuropathy (46%), nausea (42%), fatigue (38%), diarrhea (33%) and fever (29%); and The phase II retreatment trial is ongoing. Full Article
Takeda Pharmaceutical Company Limited's Millennium: The Takeda Oncology Company And Seattle Genetics, Inc Initiate Global Phase III Trial Of ADCETRIS
Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited and Seattle Genetics, Inc. announced the initiation of an international pivotal phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in patients with CD30-expressing cutaneous T-cell lymphoma (CTCL) who received at least one prior systemic therapy. The global multi-center study with ADCETRIS, an antibody-drug conjugate (ADC) directed to CD30, will be conducted in the United States, Europe, Australia and Brazil. The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) regarding the trial design. The study also received European Medicines Agency (EMA) scientific advice. The study is a randomized, open-label, phase III trial of ADCETRIS versus investigator’s choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with primary cutaneous anaplastic large cell lymphoma (pcALCL) or mycosis fungoides (MF). The primary endpoint of the study is overall response rate (ORR), lasting at least four months, with ADCETRIS in patients with CD30-positive MF or pcALCL compared to that achieved with therapy in the control arm. The key secondary endpoints are complete response (CR), progression-free survival (PFS), and burden of symptoms. Approximately 124 patients will be enrolled in the pivotal trial. Full Article
Seattle Genetics And Millennium Reports Data From Phase I Trial Of ADCETRIS In Front-line Mature T-Cell Lymphomas
Seattle Genetics and Millennium announced interim results from 32 patients treated to date in a phase I clinical trial of ADCETRIS (brentuximab vedotin) administered in combination with 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. The data are being presented at the T-Cell Lymphoma Forum being held January 26-28, 2012 in San Francisco, CA. ADCETRIS is not approved for use in front-line mature T-cell lymphoma. Full Article
BRIEF-Seattle Genetics down 3.6 percent in premarket
NEW YORK, Feb 13 - Seattle Genetics Inc : * Shares down 3.6 percent in premarket trading after results
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