By Andrea: http://nursingoncologyjob.com
Seattle Genetics, Inc.(SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited , today announced that brentuximab vedotin (SGN-35) will be featured in three poster presentations at the 8th International Symposium on Hodgkin Lymphoma (ISHL) being held October 23-26, 2010 in Cologne, Germany.
The following posters will be presented on Tuesday, October 26, 2010:
Objective responses with SGN-35 retreatment in CD30-positive hematologic malignancies: a case series (Abstract #113) Activity, safety and tolerability of antibody-drug conjugate (ADC) SGN-35 in relapsed/refractory Hodgkin lymphoma and CD30+ hematologic malignancies (Abstract #74) Activity of SGN-35 in preclinical models of combination therapy and relapse prevention (Abstract #49)
"These presentations complement the recent positive results from our pivotal Hodgkin lymphoma and phase II systemic anaplastic large cell lymphoma (ALCL) trials, both in the relapsed or refractory setting, and describe the additional opportunities we are pursuing to meet the needs of patients with CD30-positive malignancies," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "In addition, we are preparing our brentuximab vedotin Biologics License Application (BLA) for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011."
"The acceptance of these presentations at ISHL underscores the scientific community's continued interest in brentuximab vedotin," said Nancy Simonian, M.D., Chief Medical Officer of Millennium. "We maintain our focus on meeting with regulators in Europe to discuss filing strategies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory ALCL."
About Brentuximab Vedotin
Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.
Seattle Genetics and Millennium recently reported top-line data from a pivotal trial of brentuximab vedotin for relapsed or refractory Hodgkin lymphoma and a phase II trial for relapsed or refractory ALCL. In the pivotal Hodgkin lymphoma trial, 75 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response was greater than six months. In the phase II ALCL trial, 86 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response has not yet been reached at a median follow up on study of approximately six months. The safety profile of brentuximab vedotin in these trials was generally consistent with prior clinical trial experience. More complete data sets from both trials will be presented in oral sessions at the American Society of Hematology (ASH) annual meeting, December 4-7, 2010, in Orlando, FL.
The companies are also conducting a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for the front-line treatment of Hodgkin lymphoma.
About the Seattle Genetics/Millennium Collaboration
Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.
About Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.
According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond autologous stem cell transplant.
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Showing posts with label Seattle Genetics. Show all posts
Showing posts with label Seattle Genetics. Show all posts
Monday, October 25, 2010
Friday, October 15, 2010
Seattle Genetics, Inc. (SGEN): Non-Hodgkin Lymphoma Update
By Andrea: http://nursingoncologyjob.com
Seattle Genetics, Inc. recently reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing. SGN-75 is an antibody-drug conjugate (ADC) targeted to CD70. The data were presented at the 35th European Society for Medical Oncology (ESMO) Congress being held in Milan, Italy.
"These preliminary data are encouraging, and show initial evidence of antitumor activity with SGN-75 in patients with relapsed/refractory non-Hodgkin lymphoma or metastatic RCC," said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine of Seattle Genetics. "We are continuing to dose escalate in this trial to further assess the safety and activity of SGN-75, as well as to establish the optimal dosing regimen for future clinical trials."
Data were reported from 16 patients in the open-label phase I clinical trial, including seven with non-Hodgkin lymphoma and nine with RCC. Cohorts of patients received SGN-75 either every three weeks at doses ranging from 0.3 to 2.0 milligrams per kilogram (mg/kg) or on a weekly basis at a dose of 0.3 mg/kg. Enrolled patients in each indication had received a median of three prior systemic therapies.
Best clinical response among non-Hodgkin lymphoma patients included one patient with a complete remission, four patients with stable disease, one patient with progressive disease and one patient who was not evaluable. Best clinical response among RCC patients included one patient with a partial response, three patients with stable disease and five patients with progressive disease. The most common adverse events were fatigue, nausea and peripheral edema (swelling). A maximum tolerated dose has not been established with either dosing schedule and dose escalation continues. (Abstract #532P)
The single-agent phase I study of SGN-75 was initiated in November 2009 and is designed to enroll up to approximately 80 patients at multiple centers in the United States. The trial is evaluating the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75. Patients enrolled in the trial must have received at least one prior therapy and have confirmed CD70 expression.
SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic cell-killing agent, monomethyl auristatin F (MMAF), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, and to release its cell-killing agent upon internalization into CD70-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.
Seattle Genetics, Inc. recently reported data from a phase I clinical trial of SGN-75 in patients with non-Hodgkin lymphoma or renal cell carcinoma (RCC). Preliminary results demonstrate tolerability and antitumor activity, including two objective responses in the first 16 patients treated. Dose-escalation is continuing. SGN-75 is an antibody-drug conjugate (ADC) targeted to CD70. The data were presented at the 35th European Society for Medical Oncology (ESMO) Congress being held in Milan, Italy.
"These preliminary data are encouraging, and show initial evidence of antitumor activity with SGN-75 in patients with relapsed/refractory non-Hodgkin lymphoma or metastatic RCC," said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine of Seattle Genetics. "We are continuing to dose escalate in this trial to further assess the safety and activity of SGN-75, as well as to establish the optimal dosing regimen for future clinical trials."
Data were reported from 16 patients in the open-label phase I clinical trial, including seven with non-Hodgkin lymphoma and nine with RCC. Cohorts of patients received SGN-75 either every three weeks at doses ranging from 0.3 to 2.0 milligrams per kilogram (mg/kg) or on a weekly basis at a dose of 0.3 mg/kg. Enrolled patients in each indication had received a median of three prior systemic therapies.
Best clinical response among non-Hodgkin lymphoma patients included one patient with a complete remission, four patients with stable disease, one patient with progressive disease and one patient who was not evaluable. Best clinical response among RCC patients included one patient with a partial response, three patients with stable disease and five patients with progressive disease. The most common adverse events were fatigue, nausea and peripheral edema (swelling). A maximum tolerated dose has not been established with either dosing schedule and dose escalation continues. (Abstract #532P)
The single-agent phase I study of SGN-75 was initiated in November 2009 and is designed to enroll up to approximately 80 patients at multiple centers in the United States. The trial is evaluating the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75. Patients enrolled in the trial must have received at least one prior therapy and have confirmed CD70 expression.
SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic cell-killing agent, monomethyl auristatin F (MMAF), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, and to release its cell-killing agent upon internalization into CD70-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.
Friday, October 8, 2010
Seattle Genetics, Inc. (SGEN): Hodgkin Lymphoma Update
By Andrea: http://www.nursingoncologyjob.com
Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced positive top-line results from the pivotal trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.
Seventy-five percent of patients in the pivotal trial achieved an objective response as assessed by an independent central review, the primary endpoint of the trial. The median duration of response was greater than six months. The safety profile of brentuximab vedotin in this trial was generally consistent with prior clinical trial experience. A more complete data set will be presented at an upcoming scientific meeting.
“We are extremely excited with the top-line results, as they move us one step closer to our goal of bringing brentuximab vedotin to patients with relapsed or refractory Hodgkin lymphoma,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are positioned for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011. In addition, we plan to report top-line data from our phase II trial of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) within the next few weeks.”
“The lack of adequate therapies for the treatment of relapsed and refractory Hodgkin lymphoma represents a substantial unmet medical need worldwide, with almost a third of the 30,000 newly diagnosed patients relapsing or becoming refractory to front-line therapy annually,” said Nancy Simonian, M.D., Chief Medical Officer of Millennium. “These data have the potential to provide an important advance in therapy for Hodgkin lymphoma. We intend to discuss these results with European regulators to support our goal of submitting a Marketing Authorization Application to the European Medicines Agency (EMA) in 2011.”
Pivotal Trial Design
The single-arm pivotal trial assessed efficacy and safety of single-agent brentuximab vedotin in relapsed or refractory, post-autologous stem cell transplant (ASCT) HL patients. Patients received 1.8 milligrams per kilogram of brentuximab vedotin every three weeks for up to 16 total doses. The primary endpoint of the trial was objective response rate as assessed by an independent review facility. Response assessments were based on the rigorous and internationally established Revised Response Criteria for Malignant Lymphoma (Cheson, 2007). Secondary endpoints included complete response rate, duration of response, progression-free survival, overall survival and tolerability. The trial was conducted under a Special Protocol Assessment (SPA) with the FDA and was discussed with the EMA during the process of obtaining EU Centralized Scientific Advice on the brentuximab vedotin development program. Brentuximab vedotin has been granted orphan drug designation by the FDA and EMA for the treatment of HL and ALCL and has been granted fast track designation by the FDA for HL.
About Brentuximab Vedotin
Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics’ proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.
In addition to the pivotal HL trial, Seattle Genetics and Millennium are conducting a phase II trial for relapsed and refractory systemic ALCL, a phase III clinical trial (the AETHERA trial) for patients at high risk of residual HL following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for front-line treatment of HL.
About Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.
According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond ASCT.
About the Seattle Genetics/Millennium Collaboration
Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.
Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced positive top-line results from the pivotal trial of single-agent brentuximab vedotin (SGN-35), an antibody-drug conjugate (ADC) targeted to CD30. The trial was conducted in 102 relapsed or refractory Hodgkin lymphoma (HL) patients.
Seventy-five percent of patients in the pivotal trial achieved an objective response as assessed by an independent central review, the primary endpoint of the trial. The median duration of response was greater than six months. The safety profile of brentuximab vedotin in this trial was generally consistent with prior clinical trial experience. A more complete data set will be presented at an upcoming scientific meeting.
“We are extremely excited with the top-line results, as they move us one step closer to our goal of bringing brentuximab vedotin to patients with relapsed or refractory Hodgkin lymphoma,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are positioned for a Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011. In addition, we plan to report top-line data from our phase II trial of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) within the next few weeks.”
“The lack of adequate therapies for the treatment of relapsed and refractory Hodgkin lymphoma represents a substantial unmet medical need worldwide, with almost a third of the 30,000 newly diagnosed patients relapsing or becoming refractory to front-line therapy annually,” said Nancy Simonian, M.D., Chief Medical Officer of Millennium. “These data have the potential to provide an important advance in therapy for Hodgkin lymphoma. We intend to discuss these results with European regulators to support our goal of submitting a Marketing Authorization Application to the European Medicines Agency (EMA) in 2011.”
Pivotal Trial Design
The single-arm pivotal trial assessed efficacy and safety of single-agent brentuximab vedotin in relapsed or refractory, post-autologous stem cell transplant (ASCT) HL patients. Patients received 1.8 milligrams per kilogram of brentuximab vedotin every three weeks for up to 16 total doses. The primary endpoint of the trial was objective response rate as assessed by an independent review facility. Response assessments were based on the rigorous and internationally established Revised Response Criteria for Malignant Lymphoma (Cheson, 2007). Secondary endpoints included complete response rate, duration of response, progression-free survival, overall survival and tolerability. The trial was conducted under a Special Protocol Assessment (SPA) with the FDA and was discussed with the EMA during the process of obtaining EU Centralized Scientific Advice on the brentuximab vedotin development program. Brentuximab vedotin has been granted orphan drug designation by the FDA and EMA for the treatment of HL and ALCL and has been granted fast track designation by the FDA for HL.
About Brentuximab Vedotin
Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics’ proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.
In addition to the pivotal HL trial, Seattle Genetics and Millennium are conducting a phase II trial for relapsed and refractory systemic ALCL, a phase III clinical trial (the AETHERA trial) for patients at high risk of residual HL following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for front-line treatment of HL.
About Hodgkin Lymphoma
Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.
According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond ASCT.
About the Seattle Genetics/Millennium Collaboration
Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.
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