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The Lancet Oncology

Wednesday, March 17, 2010

Dutch Diagnostic Company to Play Pivotal Role in ISPY-2 Trial for Breast Cancer

Agendia, a Netherlands genomics cancer diagnostics company and a world leader in molecular cancer diagnostics focused on the personalized treatment of breach cancer patients, will play a major role in the I-SPY 2 TRIAL for breast cancer. The trial is set to launch at the first of nearly twenty research sites.

I-SPY 2 is an exciting and groundbreaking new clinical trial model that will help scientists quickly and efficiently test the most promising drugs in development for women with higher risk, rapidly growing breast cancers-women for whom an improvement over standard treatment could dramatically change the odds of survival. I-SPY is an initiative of The Biomarkers Consortium, a unique public-private partnership that includes the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH).

"Cancer tumor profiling in the neoadjuvant setting is critical to the success of the I-SPY 2 trial. Agendia is uniquely positioned to be a part of the Biomarker Consortium in this landmark study, and proud to be working side by side with a large number of visionary therapeutic companies and research centers," said Bernhard Sixt, Chief Executive Officer of Agendia. "Agendia's MammaPrint has proven value for breast cancer recurrence in the neoadjuvant and adjuvant settings, Agendia's TargetPrint provides objective, quantitative information about the expression of ER, PR and Her-2neu, while our DiscoverPrint measures the expression of the whole genome. In concert they will form an integral part of the clinically relevant discoveries the Consortium aims to make."

MammaPrint, the first and only highly accurate breast cancer recurrence test cleared by the U.S. Food and Drug Administration under the in vitro diagnostic multivariate index assay (IVDMIA) guidelines, identifies patients with early metastasis risk - patients who are likely to develop metastases within five years following surgery. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test results provide doctors with a clear rationale to assess the benefit of chemotherapy in addition to other clinical information and pathology tests.

Scientists from the National Cancer Institute (NCI), FDA, and nearly 20 major cancer research centers across the United States have united to develop and conduct this unprecedented large-scale scientific collaboration to test novel breast cancer drugs in the neoadjuvant clinical trial setting. Results will be made broadly available to the cancer research and development community in order to foster this integrated approach to improve clinical trial success and the efficacy of cancer therapeutics.

Thursday, March 4, 2010

European Breast Cancer Patients to be Treated With Revolutionary Therapy System

For the first time, breast cancer patients in Europe will receive treatment using a revolutionary system called AccuBoost. The Italian hospital where the patients are being treated is using the technology to pinpoint the tumor bed and treat it whilst still protecting the patient's healthy surrounding tissue and organs.

The new treatment option is made possible by the system combining real-time mammographic image guidance and non-invasive use of a radiotherapy technique called brachytherapy, a high-precision radiation therapy in which the radiation source used to kill cancer cells and shrink tumors is placed in or close to the tumor itself. Precision brachytherapy allows a physician to concentrate a high dose of radiation in a small area, minimizing damage to nearby, healthy body tissue and organs, over a shorter treatment period.

Professor Roberto Orecchia; Director of the Division of Radiotherapy, is leading the use of the new system at the Istituto Europeo di Oncologia in Milan and explained: 'When the patient is treated with AccuBoost, the image is seen in real-time, guaranteeing radiotherapy that is extremely precise in its targeting of the tumour bed. This is a very innovative procedure because for the first time mammography images can be used to guide the radiotherapy treatment in such an extremely precise and adaptive manner. There is also a time benefit, so this year, we will be able to treat 50 percent of patients more quickly and efficiently than before, reducing treatment time from six weeks to three weeks.'

The Istituto Europeo di Oncologia is the first hospital in Europe to use AccuBoost, which was certified for use in Europe just six weeks ago. The technology was developed by Nucletron, a knowledge-based leader in Radiation Oncology, and ART a company dedicated to the advancement of partial breast irradiation with the goal of reducing the cancer recurrence rate and minimizing radiation related complications. The two companies specialize in advancing radiation oncology by developing state-of-the-art equipment for high precision brachytherapy.

Wednesday, March 3, 2010

Updated IMPACT Results Confirm that Provenge® Improves Overall Survival in Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC)

Data from the pivotal Phase 3 IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study, a 512-patient, multi-center, randomized, double-blind, placebo-controlled study evaluating men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC) with overall survival as the primary endpoint, demonstrates that sipuleucel-T (Provenge®, Dendreon Corporation) does extends overall survival in men with CRPC. The data will be presented at the American Society of Clinical Oncology 2010 Genitourinary Cancers Symposium (ASCO-GU) in San Francisco on Friday, March 5 at 1:45 pm PT.

Active Cellular Immunotherapies

Sipuleucel-T is an investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of Active Cellular Immunotherapies (ACIs) specifically designed to engage the patient's own immune system against cancer. The drug candidate and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In contrast to Passive Cellular Immunotherapy, where effector cells are infused into the patient but not induced or expanded within the patient, ACI involves inducing an effective response to tumor cells within patients whose immune systems have failed to do so on their own. These methods generally involve introducing tumor antigens to the host effector cells.


A sensitivity analysis performed with longer-term follow-up (36.5 months) and additional events (349 deaths) collected at the time of study closure demonstrated that sipuleucel-T increased three-year survival by 40 percent compared to placebo (32.1% vs 23.0%), the median survival difference of sipuleucel-T compared to placebo was maintained at 4.1 months, with a 24.1% reduction in the risk of death [HR=0.759] and a p-value of 0.017.

As previously reported in a primary analysis (34.1 months median follow-up; 331 deaths), the IMPACT study met its pre-specified primary endpoint of significantly improving overall survival compared to placebo, demonstrating that sipuleucel-T increased three-year survival by 38 percent compared to placebo (31.7% vs 23.0%), extending median survival by 4.1 months compared to placebo (25.8 months vs. 21.7 months), with a 22.5 percent reduction in the risk of death [HR=0.775] and a p-value of 0.032.

In addition, new analyses demonstrated that the median predicted survival of the two treatment arms using the Halabi model were well balanced (20.3 months for sipuleucel-T vs 21.2 months for placebo). Furthermore, in an analysis in which patients were censored at the time of docetaxel use, the sipuleucel-T treatment effect remained strong [HR=0.649].

As previously reported, the most common adverse reactions were chills, fever, headache, aches, influenza-like illness and sweating.

"The results from the IMPACT study corroborate earlier studies with sipuleucel-T in demonstrating an improvement in overall survival for men with metastatic castration resistant prostate cancer. This is the first therapeutic vaccine to demonstrate a survival benefit in cancer," said Philip Kantoff, M.D., Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and principal investigator of the IMPACT study. "Furthermore, the results of this study validate cancer immunotherapy as an entirely new treatment paradigm that can provide patients with a clinically meaningful survival benefit coupled with a well-tolerated safety profile."

License Application

Dendreon Corporation is seeking licensure for sipuleucel-T for men with metastatic CRPC and submitted an amended Biologics License Application for which the U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act date of May 1, 2010.