By Andrea: http://nursingoncologyjob.com
Today from 9:30am-6pm the staff and teachers at Quiltique will be auctioning off their “blinged” bras to raise money for the Susan G. Komen Foundation.
The idea started with a post on the BERNINA Blog. They invited their blog’s readers to “Bling their Bra” in October, to celebrate Breast Cancer Awareness Month. Quiltique, a local Henderson quilt shop took the idea one step further. They asked their staff and teachers to create over-the-top lingerie creations to auction, with the auction proceeds going to the Susan G. Komen Foundation. The staff and teachers went wild, creating one-of-a-kind originals, some of which would turn the head of even the most seasoned Las Vegas Stripper.
Though the staff has taken a whimsical approach, the goal is clear – to raise money to fight breast cancer, a disease that has affected far too many mothers, daughters, sisters, aunts, grandmothers, cousins… and dear friends.
For customers interested in a treat for the stomach as well as the eyes, the staff has baked up culinary sensations to sell at their bake sale, also on October 16th, which will also benefit Susan G. Komen.
Quiltique is a boutique quilt shop in Henderson, Nevada that has been family owned and operated since 2003. It is located at 213 N. Stephanie, on the corner of Stephanie and American Pacific.
Saturday, October 16, 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.
Tuesday, October 12, 2010
Greenville, SC: Institute for Translational Oncology Research
By Andrea: http://nursingoncologyjob.com
Greenville Hospital System University Medical Center is paving the way for a new wave of Oncology Research through the opening of its new Institute for Translational Oncology Research. The new center will work on the development of new drugs, diagnostic discovery, and advanced cancer care:
ITOR is part of the GHS Cancer Center, a recognized regional multi-disciplinary center. ITOR partners will include leading pharmaceutical companies, research universities, private industry and the government. GHS made the announcement today (Oct. 12).
The new institute, known as ITOR, builds on the success of GHS' Clinical Research Unit and its rapidly-developing biorepository tissue-banking service, which helped make GHS one of the country's prominent players in the development of promising new oncology drugs. Numerous first-in-human studies have been conducted through the CRU, which began in 2004 as part of GHS' long-standing relationship with Cancer Centers of the Carolinas.
The evolving institute is steadily moving into the arena of personalized gene-based cancer therapies, which match the treatment to tumor-specific genetic abnormalities and patient-specific predictors of toxicity. Such translational research helps bring discovery directly from the lab to practical applications in patients. Part of ITOR's strength is its focus on using innovative public and private sector partnerships and initiatives to advance leading-edge cancer care.
"Through ITOR, we will be able to make new therapies accessible to patients far more quickly than traditional models have allowed," said Joe Stephenson, M.D., who serves as the institute's medical director.
To accomplish the goal of speeding-up the delivery of patient-specific therapies, ITOR strives to identify new ways to achieve earlier prediction of drug success, find new applications and patients for existing drugs and integrate advanced molecular and gene-based technologies into diagnostic and treatment protocols.
In practical terms, that means ITOR is focused on developing a more personalized approach to cancer therapy – targeting the right drug to the right patient – by integrating leading-edge technologies such as molecular profiling into an enhanced drug validation process.
Pharmaceutical and industry partners include long-time collaborator U.S. Oncology, Caris Life Sciences and Lab21, as well as Amgen, AstraZeneca, Japanese-based Eisai Pharmaceuticals, Oncolix and Novartis, which recently selected ITOR as one of its newest designated phase 1 clinical trial sites. Early academic partners also include the Cancer Research Center of the University of South Carolina.
Greenville Hospital System University Medical Center is paving the way for a new wave of Oncology Research through the opening of its new Institute for Translational Oncology Research. The new center will work on the development of new drugs, diagnostic discovery, and advanced cancer care:
ITOR is part of the GHS Cancer Center, a recognized regional multi-disciplinary center. ITOR partners will include leading pharmaceutical companies, research universities, private industry and the government. GHS made the announcement today (Oct. 12).
The new institute, known as ITOR, builds on the success of GHS' Clinical Research Unit and its rapidly-developing biorepository tissue-banking service, which helped make GHS one of the country's prominent players in the development of promising new oncology drugs. Numerous first-in-human studies have been conducted through the CRU, which began in 2004 as part of GHS' long-standing relationship with Cancer Centers of the Carolinas.
The evolving institute is steadily moving into the arena of personalized gene-based cancer therapies, which match the treatment to tumor-specific genetic abnormalities and patient-specific predictors of toxicity. Such translational research helps bring discovery directly from the lab to practical applications in patients. Part of ITOR's strength is its focus on using innovative public and private sector partnerships and initiatives to advance leading-edge cancer care.
"Through ITOR, we will be able to make new therapies accessible to patients far more quickly than traditional models have allowed," said Joe Stephenson, M.D., who serves as the institute's medical director.
To accomplish the goal of speeding-up the delivery of patient-specific therapies, ITOR strives to identify new ways to achieve earlier prediction of drug success, find new applications and patients for existing drugs and integrate advanced molecular and gene-based technologies into diagnostic and treatment protocols.
In practical terms, that means ITOR is focused on developing a more personalized approach to cancer therapy – targeting the right drug to the right patient – by integrating leading-edge technologies such as molecular profiling into an enhanced drug validation process.
Pharmaceutical and industry partners include long-time collaborator U.S. Oncology, Caris Life Sciences and Lab21, as well as Amgen, AstraZeneca, Japanese-based Eisai Pharmaceuticals, Oncolix and Novartis, which recently selected ITOR as one of its newest designated phase 1 clinical trial sites. Early academic partners also include the Cancer Research Center of the University of South Carolina.
Novel Kinase Inhibitors: Oncology Research Update
By Andrea: http://nursingoncologyjob.com
ArQule, Inc. (ARQL) and Daiichi Sankyo Co. recently announced that they will expand on their current research and development to continue the exploration of novel kinase inhibitors in Oncology:
ArQule, Inc. (ARQL) and Daiichi Sankyo Co., Ltd. today announced the expansion of their research, development and license agreement for the discovery of novel kinase inhibitors in the field of oncology. This expanded agreement establishes a third therapeutic target, with an option for a fourth, in the field of oncology, and it includes a two-year extension based on the application of the proprietary ArQule Kinase Inhibitor Platform (AKIP(TM)) technology.
"This technology has provided us with a unique and innovative approach for discovery in the treatment of cancer," said Dr. Hideyuki Haruyama, the Global Head of Research, Daiichi Sankyo. "We expect that the expansion of this collaboration will produce other drug candidates and lay the foundation for future growth in this field."
Consistent with the existing AKIP(TM) collaboration, the economic terms provided for in the expanded agreement include payments for research support, licensing fees for compounds discovered as a result of this research, milestone payments related to clinical development, regulatory review and sales, and tiered royalty payments on net sales of each product. Daiichi Sankyo will have an option to license compounds directed to the targets defined under the agreement following the completion of certain pre-clinical studies. ArQule retains the option to co-commercialize any resulting licensed products in the U.S.
"Our initial drug discovery collaboration has identified a development candidate for one target, and we are optimizing advanced lead compounds for the other target," said Dr. Thomas C.K. Chan, chief scientific officer of ArQule. "The expansion of this collaboration will continue to deploy AKIP technology to discover inhibitors with novel modes of action for additional oncology targets over the next two years."
ArQule, Inc. (ARQL) and Daiichi Sankyo Co. recently announced that they will expand on their current research and development to continue the exploration of novel kinase inhibitors in Oncology:
ArQule, Inc. (ARQL) and Daiichi Sankyo Co., Ltd. today announced the expansion of their research, development and license agreement for the discovery of novel kinase inhibitors in the field of oncology. This expanded agreement establishes a third therapeutic target, with an option for a fourth, in the field of oncology, and it includes a two-year extension based on the application of the proprietary ArQule Kinase Inhibitor Platform (AKIP(TM)) technology.
"This technology has provided us with a unique and innovative approach for discovery in the treatment of cancer," said Dr. Hideyuki Haruyama, the Global Head of Research, Daiichi Sankyo. "We expect that the expansion of this collaboration will produce other drug candidates and lay the foundation for future growth in this field."
Consistent with the existing AKIP(TM) collaboration, the economic terms provided for in the expanded agreement include payments for research support, licensing fees for compounds discovered as a result of this research, milestone payments related to clinical development, regulatory review and sales, and tiered royalty payments on net sales of each product. Daiichi Sankyo will have an option to license compounds directed to the targets defined under the agreement following the completion of certain pre-clinical studies. ArQule retains the option to co-commercialize any resulting licensed products in the U.S.
"Our initial drug discovery collaboration has identified a development candidate for one target, and we are optimizing advanced lead compounds for the other target," said Dr. Thomas C.K. Chan, chief scientific officer of ArQule. "The expansion of this collaboration will continue to deploy AKIP technology to discover inhibitors with novel modes of action for additional oncology targets over the next two years."
Friday, October 8, 2010
European Society for Medical Oncology (ESMO) - Portal for Cancer Research
By Andrea: http://www.oncologynursingjob.com
A unique portal, offering oncologists access to the latest information in the field of cancer research, will be launched in 2011 by the European Society for Medical Oncology (ESMO) in association with Thomson Reuters. The announcement was made today at the 35th ESMO Congress taking place from 8 to 12 October, in Milan, Italy.
Prof David J Kerr, President of ESMO, presented the Society's latest project at the Opening Press Conference. "ESMO is the leading European professional organization for oncologists," declared Professor Kerr. "We strive to serve our members and this year we are particularly excited about the launch of OncologyPRO. OncologyPRO stands for Oncology Professional Resources Online and is a unique scientific portal for ESMO members, providing instant access to the highest quality scientific knowledge in one easy-to-access portal. ESMO is proud to announce an exclusive partnership with Thomson Reuters, the world's largest information provider, to create the site, which gives cancer specialists access to the most complete resources in oncology today."
"First-class online resources for members are essential for knowledge-based societies and we are delighted to provide ESMO members with such a resource in OncologyPRO, our new state-of-the-art web site," said Mr. Alan Howard, ESMO CEO. "ESMO has listened to its members and carefully evaluated their needs, both in the clinical and research settings. OncologyPRO provides a variety of services, far beyond the level of service an individual society could provide, thanks to our partnership with the Thomson Reuters organization. We are confident this service will be highly appreciated by our members."
"OncologyPRO is an innovative collaboration between ESMO and Thomson Reuters that gives practicing clinicians an information portal tailored to meet their specific needs," added Jon Brett-Harris, Executive Vice President at Thomson Reuters. "We're delighted that our most up-to-date and clinically relevant content will be offered in a way that enables ESMO members to work more efficiently and ultimately to the benefit of patient outcomes."
A unique portal, offering oncologists access to the latest information in the field of cancer research, will be launched in 2011 by the European Society for Medical Oncology (ESMO) in association with Thomson Reuters. The announcement was made today at the 35th ESMO Congress taking place from 8 to 12 October, in Milan, Italy.
Prof David J Kerr, President of ESMO, presented the Society's latest project at the Opening Press Conference. "ESMO is the leading European professional organization for oncologists," declared Professor Kerr. "We strive to serve our members and this year we are particularly excited about the launch of OncologyPRO. OncologyPRO stands for Oncology Professional Resources Online and is a unique scientific portal for ESMO members, providing instant access to the highest quality scientific knowledge in one easy-to-access portal. ESMO is proud to announce an exclusive partnership with Thomson Reuters, the world's largest information provider, to create the site, which gives cancer specialists access to the most complete resources in oncology today."
"First-class online resources for members are essential for knowledge-based societies and we are delighted to provide ESMO members with such a resource in OncologyPRO, our new state-of-the-art web site," said Mr. Alan Howard, ESMO CEO. "ESMO has listened to its members and carefully evaluated their needs, both in the clinical and research settings. OncologyPRO provides a variety of services, far beyond the level of service an individual society could provide, thanks to our partnership with the Thomson Reuters organization. We are confident this service will be highly appreciated by our members."
"OncologyPRO is an innovative collaboration between ESMO and Thomson Reuters that gives practicing clinicians an information portal tailored to meet their specific needs," added Jon Brett-Harris, Executive Vice President at Thomson Reuters. "We're delighted that our most up-to-date and clinically relevant content will be offered in a way that enables ESMO members to work more efficiently and ultimately to the benefit of patient outcomes."
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.
Pfizer: Oncology Research Update
By Andrea: http://www.nursingoncologyjob.com
Pfizer (PFE) Oncology will present new data across its portfolio representing novel approaches to researching treatments for patients with rare and difficult-to-treat cancers. These results will be presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy from October 8-12.
"Pfizer (NYSE: PFE) has focused its oncology research on targeting molecular drivers and pathways in various cancers, such as EGFR, ALK and IGF-1R," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "We are committed to using this approach to seek treatments for well-known, difficult-to-treat and rare tumor types that have few or no therapeutic options and where we can make a big impact in defined patient populations."
At ESMO, Pfizer will present data on key compounds from its portfolio, which includes:
* PF-00299804
Updated results from a global, randomized Phase 2 trial evaluating the anti-tumor activity and safety of PF-00299804 compared to erlotinib in patients with NSCLC following progression on treatment with one or more chemotherapy regimens (Abstract #365PD, October 10).(1) In addition, preliminary efficacy and safety data from a Phase 2 study evaluating PF-00299804 as first-line treatment in patients with advanced NSCLC whose tumors are likely to carry the EGFR mutation will be presented as a late breaker in a Proffered Paper session (Abstract #LBA18, October 11).(2)
PF-00299804 is an investigational, oral, pan-HER (pan-human epidermal growth factor receptor) inhibitor.(2) PF-00299804 is currently being evaluated in the BR.26 clinical trial, a Phase 3, double-blind, placebo-controlled, randomized study in patients with stage IIIB/IV NSCLC who have progressive disease following standard chemotherapy and EGFR inhibitor therapy.(3) BR.26 is led by the NCIC Clinical Trials Group (CTG).(3)
* Crizotinib (PF-02341066)
Updated data on crizotinib (PF-02341066), a first-in-class, oral ALK inhibitor, will also be presented, from the ongoing expansion cohort from the Phase 1 study evaluating the compound in patients with ALK-positive advanced NSCLC (Abstract #366PD, October 10).(4)
* Sunitinib
Pfizer will also present results from SUN 1087, a Phase 3 trial evaluating sunitinib plus erlotinib compared to erlotinib alone in patients with advanced NSCLC who have received at least one previous treatment with a platinum-based regimen (Abstract #LBA6, October 11).(5) In August, Pfizer announced that this study demonstrated a statistically significant improvement in progression-free survival but not in overall survival. Overall survival was the primary endpoint of the study and progression free survival was the secondary endpoint of the study.
Pfizer will also present progression-free survival (PFS) data as determined by blinded independent central review (BICR) from the pivotal, placebo-controlled SUN 1111 Phase 3 trial evaluating sunitinib in patients with progressive, well-differentiated pancreatic neuroendocrine tumor (NET) (Abstract #747P, October 9).(6)
* Figitumumab
Results from a Phase 1/2 study evaluating figitumumab (CP-751,871), a selective fully human IgG2 monoclonal antibody against the IGF-1R (insulin-like growth factor 1 receptor) pathway, in patients with refractory Ewing's sarcoma and other sarcomas will be presented in a Proffered Paper session (Abstract #1344O, October 10).(7)
Pfizer continues to investigate approved therapies within its portfolio, including Aromasin® (exemestane tablets). At the Congress, research findings for the compound will be presented in two key presentations.
- Distant recurrences at median of 5-years among 9,779 postmenopausal women with hormone receptor-positive early breast cancer treated on the TEAM trial of adjuvant endocrine therapy (Abstract #213O, October 11)(8)
- Effects of exemestane or tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial: a meta-analysis (Abstract #225P, October 10)(9)
Data on the following compounds and investigational agents will also be presented: neratinib (HER2 positive breast, solid tumors),(10),(11) axitinib (renal cell carcinoma or RCC),(12) inotuzumab (non-Hodgkin's lymphoma),(13) and Torisel® (temsirolimus) (RCC, solid tumors).(14),(15)
Pfizer (PFE) Oncology will present new data across its portfolio representing novel approaches to researching treatments for patients with rare and difficult-to-treat cancers. These results will be presented at the 35th European Society for Medical Oncology (ESMO) Congress in Milan, Italy from October 8-12.
"Pfizer (NYSE: PFE) has focused its oncology research on targeting molecular drivers and pathways in various cancers, such as EGFR, ALK and IGF-1R," said Dr. Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit. "We are committed to using this approach to seek treatments for well-known, difficult-to-treat and rare tumor types that have few or no therapeutic options and where we can make a big impact in defined patient populations."
At ESMO, Pfizer will present data on key compounds from its portfolio, which includes:
* PF-00299804
Updated results from a global, randomized Phase 2 trial evaluating the anti-tumor activity and safety of PF-00299804 compared to erlotinib in patients with NSCLC following progression on treatment with one or more chemotherapy regimens (Abstract #365PD, October 10).(1) In addition, preliminary efficacy and safety data from a Phase 2 study evaluating PF-00299804 as first-line treatment in patients with advanced NSCLC whose tumors are likely to carry the EGFR mutation will be presented as a late breaker in a Proffered Paper session (Abstract #LBA18, October 11).(2)
PF-00299804 is an investigational, oral, pan-HER (pan-human epidermal growth factor receptor) inhibitor.(2) PF-00299804 is currently being evaluated in the BR.26 clinical trial, a Phase 3, double-blind, placebo-controlled, randomized study in patients with stage IIIB/IV NSCLC who have progressive disease following standard chemotherapy and EGFR inhibitor therapy.(3) BR.26 is led by the NCIC Clinical Trials Group (CTG).(3)
* Crizotinib (PF-02341066)
Updated data on crizotinib (PF-02341066), a first-in-class, oral ALK inhibitor, will also be presented, from the ongoing expansion cohort from the Phase 1 study evaluating the compound in patients with ALK-positive advanced NSCLC (Abstract #366PD, October 10).(4)
* Sunitinib
Pfizer will also present results from SUN 1087, a Phase 3 trial evaluating sunitinib plus erlotinib compared to erlotinib alone in patients with advanced NSCLC who have received at least one previous treatment with a platinum-based regimen (Abstract #LBA6, October 11).(5) In August, Pfizer announced that this study demonstrated a statistically significant improvement in progression-free survival but not in overall survival. Overall survival was the primary endpoint of the study and progression free survival was the secondary endpoint of the study.
Pfizer will also present progression-free survival (PFS) data as determined by blinded independent central review (BICR) from the pivotal, placebo-controlled SUN 1111 Phase 3 trial evaluating sunitinib in patients with progressive, well-differentiated pancreatic neuroendocrine tumor (NET) (Abstract #747P, October 9).(6)
* Figitumumab
Results from a Phase 1/2 study evaluating figitumumab (CP-751,871), a selective fully human IgG2 monoclonal antibody against the IGF-1R (insulin-like growth factor 1 receptor) pathway, in patients with refractory Ewing's sarcoma and other sarcomas will be presented in a Proffered Paper session (Abstract #1344O, October 10).(7)
Pfizer continues to investigate approved therapies within its portfolio, including Aromasin® (exemestane tablets). At the Congress, research findings for the compound will be presented in two key presentations.
- Distant recurrences at median of 5-years among 9,779 postmenopausal women with hormone receptor-positive early breast cancer treated on the TEAM trial of adjuvant endocrine therapy (Abstract #213O, October 11)(8)
- Effects of exemestane or tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial: a meta-analysis (Abstract #225P, October 10)(9)
Data on the following compounds and investigational agents will also be presented: neratinib (HER2 positive breast, solid tumors),(10),(11) axitinib (renal cell carcinoma or RCC),(12) inotuzumab (non-Hodgkin's lymphoma),(13) and Torisel® (temsirolimus) (RCC, solid tumors).(14),(15)
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