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seattle genetics inc (SGEN) Key Developments

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.

Seattle Genetics Inc. Announces Executive Changes

Seattle Genetics Inc. announced the appointment of Jean I. Liu, as general counsel, executive vice president, legal affairs and corporate secretary. She will report to Clay Siegall, president and chief executive officer. Ms. Liu replaces Kirk Schumacher, who has been with Seattle Genetics since 2004 and is retiring. Prior to joining Seattle Genetics, Ms. Liu served since 2011 as Vice President and General Counsel at Halozyme.

Seattle Genetics Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014; Revises Revenue Results for the Fourth Quarter of 2014

Seattle Genetics reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported net loss of $15,566,000 or $0.13 per basic and diluted share on total revenues of $75,853,000 compared to net loss of $23,686,000 or $0.19 per basic and diluted share on total revenues of $70,969,000 reported a year ago. Loss from operations was $15,625,000 compared to $23,784,000 reported a year ago. Net revenue for the quarter was $48.2 million, an 8% increase over second quarter 2013. R&D expenses were $58.5 million. For the nine months, the company reported net loss of $49,457,000 or $0.40 per basic and diluted share on total revenues of $212,432,000 compared to net loss of $46,849,000 or $0.39 per basic and diluted share on total revenues of $201,855,000 reported a year ago. Loss from operations was $49,639,000 compared to $47,180,000 reported a year ago. ADCETRIS net sales in the U.S. and Canada in the third quarter were $131.7 million, a 24% increase compared to the first 9 months of 2013. R&D expenses were $166.7 million for year-to-date in 2014 The company anticipates that 2014 revenues from ADCETRIS net product sales in the U.S. and Canada will be higher than previously anticipated, and are now expected to be in the range of $172 million to $177 million. The company also anticipates that 2014 collaboration revenues will be higher than previously anticipated, and are now expected to be in the range of $64 million to $68 million. Guidance indicates a 20% approximately increase in ADCETRIS sales from 2013 to 2014.

Seattle Genetics Inc. Presents at Credit Suisse Annual Healthcare Conference, Nov-11-2014 08:30 AM

Seattle Genetics Inc. Presents at Credit Suisse Annual Healthcare Conference, Nov-11-2014 08:30 AM. Venue: The Biltmore, 2400 E Missouri Ave, Phoenix, AZ 85016, United States. Speakers: Clay B. Siegall, Co-Founder, Chairman, Chief Executive Officer and President.

 

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