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Myriad Genetics and Tufts Health Plan Sign Agreement to Cover Prolaris(R) for Members With Localized Prostate Cancer

On October 7, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported that it has signed a three-year contract with Tufts Health Plan through which the plan will provide coverage of Prolaris for members diagnosed with localized prostate cancer (Press release, Myriad Genetics, OCT 7, 2015, View Source [SID:1234507661]). Prolaris is the first and only biopsy test validated against prostate cancer specific mortality.

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Tufts Health Plan is a leading health plan in the Northeast with more than one million members. Tufts Health Plan’s members will benefit from this agreement, which is designed to drive optimal treatment because men can confidently pursue active surveillance for tumors identified as being less aggressive with Myriad’s extensively validated Prolaris combined score. Recent data show that many men realize no benefit from interventional treatment, and many suffer needlessly from the side effects associated with radical prostatectomy and radiation.

"Myriad is excited to offer Prolaris testing to Tufts Health Plan’s members. We believe it will help to improve patient care and lower healthcare costs," said Nicole Lambert, general manager, Urology Business Unit, Myriad Genetic Laboratories. "The Prolaris test has been validated in multiple clinical studies and provides substantially stronger prognostic power than standard pathology. The Prolaris test enables physicians to confidently tailor treatment plans for their patients."

About Prolaris

Prolaris is a prognostic test that measures the expression level of genes involved with tumor proliferation to predict disease outcome. Prolaris is the only test that provides insight into meaningful oncologic endpoints by predicting 10-year prostate cancer-specific mortality, thereby guiding medical management. For more information visit: www.prolaris.com.

Varian Announces U.S. Clearance and CE Mark for VitalBeam™ Package; Chirayu Medical College in Bhopal Acquires the New Platform for Advanced Radiotherapy

On October 7, 2015 Varian Medical Systems reported that the Chirayu Medical College and Hospital (CMCH) in Bhopal, India, is among the first cancer treatment centers around the world to acquire the new VitalBeam platform from Varian Medical Systems (NYSE: VAR), offering clinics a modular technology package for affordable, high-quality, high-throughput radiotherapy, and for expanding clinical capabilities over time (Press release, InfiMed, OCT 7, 2015, View Source [SID:1234507660]).

The VitalBeam radiotherapy treatment platform from Varian Medical Systems
Varian recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as well as the CE Mark for the VitalBeam platform. In addition to the CMCH in India, treatment centers in the U.S. and Europe have now ordered the system, which incorporates many of the innovations Varian developed to enhance the precision, safety, and speed of treatment on its popular TrueBeam radiotherapy system.

The VitalBeam system at the CMCH will anchor a new radiotherapy department there, complementing existing medical oncology services. "We are looking to increase the capacity in our region for helping cancer patients with the most advanced treatments possible and we are making efforts to provide patients with the best available treatments in the world," said Ajay Goenka, M.D., owner of CMCH. "We chose VitalBeam because we wanted something with the advantages of the TrueBeam platform that would enable us to go beyond basic intensity-modulated radiotherapy."

"The VitalBeam system will enable us to complete image-guided treatments quickly—in as little as 2-4 minutes when using advanced capabilities like RapidArc—and to shape the radiation dose very precisely," added T. P. Sahoo, M.D., physician at the CMCH. "That will be good news for the cancer patients of our region."

According to Dr. Sahoo, the clinical team at the CMCH will use the VitalBeam system to treat patients with tumors in vital locations where toxicity to healthy tissues must be minimized. "I anticipate that we will use it curatively, to treat head and neck, brain, pancreatic, and other abdominal malignancies, because these are common cancers that can be addressed with advanced radiotherapy."

"Our goal, with this platform, was to help increase access to quality cancer care around the world," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "We are gratified to work with institutions like the Chirayu Medical College in bringing advanced, image-guided radiotherapy to more cancer patients."

Cancer Research UK invests £15 million to unite finest minds across UK to develop better treatments

On October 7, 2015 Cancer Research UK reported that it has invested £15 million to inspire collaborative cancer research between scientists across the UK through a new awards scheme launched today (Press release, Cancer Research UK, OCT 7, 2015, View Source [SID:1234507659]).

"Effective partnerships are crucial for delivering the greatest science and boosting advancements in fighting cancer." – Dr David Scott

The Cancer Research UK Centres Network Accelerator Award is a new initiative which provides infrastructure support to research centres in order to encourage collaboration between different organisations and boost ‘bench to bedside’ science.

Four centres – Queens University Belfast (link is external), the University of Leicester (link is external), the Francis Crick Institute (link is external), and the University College London (link is external)– have each received a five-year grant.

Queens University Belfast* received £3.9 million to develop new pathology and image analysis techniques for solid tumours. This includes research to improve cancer diagnosis through tissue imaging, biomarker discovery, and clinical trials. The award will also invest in the next generation of scientists with a Clinical Fellowship programme in molecular pathology.

The University of Leicester** received £1.7 million to set up facilities to study structural biology among centres to improve drug development. The award will focus on research to translate the understanding of structural biology into drugs that could treat patients.

The Francis Crick Institute*** received £4.2 million to support more experimental cancer research and create Clinical Research Fellowships to help unite different research centres in London. This will help turn innovation in the laboratory into tangible benefits for patients – to save more lives from the disease in the future.

University College London**** received £5 million to help advance immunotherapy research – a field of cancer research which has shown promise for a long time and recently provided exciting breakthroughs in cancer treatments. The award will fund research to understand how patients develop immune responses – and why they stop responding to treatments. The award will also help scientists develop new therapies, and safe ways to give treatments.

Professor David Waugh, Director of the Centre for Cancer Research and Cell Biology at Queens University Belfast, said: "This award will allow us to accelerate the development of clinically-robust diagnostic tests that assist in personalizing cancer therapy. The network will help us set technology standards for this increasingly important and fast growing area of cancer research."

Professor Catrin Pritchard, science director at the Cancer Research UK Leicester Centre, said: "Personalised medicine is the future of cancer treatment, and by collaborating with centres across the UK, we look forward to accelerating research underpinning drug development."

Dr Richard Treisman, a research director at the Francis Crick Institute, said: "Thinking outside the box and collaborating across different disciplines and institutions is what we need to invigorate more innovative cancer research."

Professor Henning Walczak, scientific director of the Cancer Research UK – UCL Centre, said: "There has been great progress in the field of cancer immunotherapy and by collaborating with centres across London our Accelerator Network aims to bring successful cancer immunotherapies to more patients and to overcome some of the hurdles in this field."

Dr David Scott, Cancer Research UK’s director of science funding, said: "Effective partnerships are crucial for delivering the greatest science and boosting advancements in fighting cancer. We’re proud to invest in collaborative and innovative research across the UK with the new Centres Network Accelerator awards. It’s through working together and uniting expertise that we will do better research and save more lives."

Kite Pharma Commends Steven A. Rosenberg, M.D., Ph.D., on the Prestigious Medal of Honor Award From the American Cancer Society

On October 7, 2015 Kite Pharma, Inc. (Kite) (Nasdaq:KITE) reported that Steven A. Rosenberg, M.D., Ph.D., Chief of Surgery at the National Cancer Institute (NCI) and a special advisor to Kite, has received three significant awards for his achievements and career dedicated to advancing cancer research (Press release, Kite Pharma, OCT 7, 2015, View Source [SID:1234507657]). The American Cancer Society (ACS), the largest voluntary health organization in the United States, awarded Dr. Rosenberg its Medal of Honor for his pioneering leadership in cancer immunotherapy. The Medal of Honor is the ACS’ highest honor and was presented to Dr. Rosenberg at a ceremony held in Washington, DC, on September 30, 2015. Additional recent awards include:

Dr. Rosenberg has been awarded the Samuel J. Heyman Service to America Medal for career achievement by the Partnership for Public Service. The "Sammies" are bestowed upon individuals to highlight excellence in the federal workforce and inspire other talented and dedicated individuals to go into public service. Dr. Rosenberg will receive his award during a gala and ceremony that is taking place tonight, October 7, in Washington, DC.

Susan G. Komen, the world’s largest breast cancer organization, awarded Dr. Rosenberg the Betty Ford Lifetime Achievement Award for his four decades of work in fighting cancer at the NCI. This award recognizes individuals who have committed their lives to engaging the public in the fight against breast cancer, advocating for meaningful change, and educating communities to support women and men facing the disease. Dr. Rosenberg was recognized during the Honoring the Promise gala, which took place in Washington, DC, on September 24, 2015.

In 2012, Kite partnered with Dr. Rosenberg and the NCI under a Cooperative Research and Development Agreement (CRADA) to further the research and development of multiple chimeric antigen receptor (CAR) and T cell receptor (TCR) based product candidates for the treatment of advanced solid and hematological malignancies. Many of these product candidates are now being assessed in clinical trials and Kite has since exclusively licensed intellectual property related to certain of these product candidates.

"We have always appreciated the great honor of being able to advance cancer therapies with Steve and are thrilled that three of the most prominent awards in medicine and public service have been made in recognition of the pivotal role Steve has played in cancer care and research on the national stage," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer of Kite. "During his long and successful career, Steve’s insights time and again have had an astounding impact on the direction of cancer research. His contributions, including to the exciting field of cancer immunotherapy, have been immense, and we are elated for Steve to receive these awards."

Merck and Pfizer Announce Investigational Immunotherapy Avelumab Receives FDA Fast Track Designation for Metastatic Merkel Cell Carcinoma

On October 7, 2015 Merck and Pfizer reported that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer (Press release, Merck KGaA, OCT 7, 2015, View Source [SID:1234507663]).1,2

This announcement builds on the recent FDA Orphan Drug designation that was granted for avelumab on September 21, 2015 for the treatment of MCC. The Fast Track designation is designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and address an unmet medical need.

"We are pleased that the FDA continues to acknowledge the current high unmet needs for patients with metastatic Merkel cell carcinoma through these recent regulatory designations for avelumab," said Dr. Luciano Rossetti, Head of Global Research & Development at Merck’s biopharmaceutical business, Merck Serono. "We look forward to working closely with the FDA on an expedited review process for avelumab, and we hope to be able to provide a potential new treatment option for patients with this difficult-to-treat cancer in the future."

"We look forward to working with our partners at Merck on the development of avelumab in patients with relapsed and refractory Merkel cell carcinoma," said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. "Fast Track designation will enable us to coordinate these efforts more closely with the FDA."

The designation relates to the clinical development program for avelumab in metastatic MCC, which includes the Phase II study, JAVELIN Merkel, to assess the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen. In this study, the primary endpoint is objective response rate, and secondary endpoints include duration of response, progression-free survival, overall survival and safety. The study, which exceeded its expected enrollment of 84 patients with 88 patients enrolled, is being conducted in sites across Asia Pacific, Australia, Europe and North America.

The clinical development program for avelumab now includes more than 1,000 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastroesophageal cancer, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer.