News in Brief

Published OnlineFirst March 7, 2013; DOI: 10.1158/2159-8290.CD-NB2013-031

NEWS IN BRIEF

PEOPLE FDA Approves Kadcyla trial’s principal investigator and a professor of medicine at Duke Cancer for Breast Cancer Charles L. Sawyers, Institute in Durham, NC. “This is an MD, chair of the The U.S. Food and Drug Adminis- exciting new way to treat cancer.” Human Oncology tration approved the antibody–drug In addition to its method of action, and Pathogenesis conjugate (ADC) ado-trastuzumab Winer says ado-trastuzumab emtansine Program at New emtansine (Kadcyla; Genentech) for is notable because it causes relatively York’s Memorial the treatment of HER2-positive meta- few side effects. “It’s one of the best- Sloan-Kettering static breast cancer on February 22. tolerated anticancer drugs I’ve ever Cancer Center, was inaugurated as presi- Called T-DM1 during clinical trials, given,” he comments. dent of the American Association for the new therapy is intended for The most commonly reported side Cancer Research (AACR) in April at the patients who have previously been effects of ado-trastuzumab emtansine organization’s 104th annual meeting in treated with the anti-HER2 therapy in clinical studies were nausea, fatigue, Washington, DC. He will serve a 1-year trastuzumab (Herceptin; Roche/ muscle and joint pain, thrombocyto- term, succeeding Frank McCormick, PhD. Genentech) and a taxane. penia, increased levels of liver enzymes, A Howard Hughes Medical Institute “It’s far better than the previ- headache, and constipation. investigator, Sawyers is a member of the ous standard therapy in this setting Ado-trastuzumab emtansine, National Cancer Advisory Board, the because it leads to improved survival which is also under study as a fi rst-line Institute of Medicine, and the National in these patients with less toxicity,” therapy for breast cancer, became Academy of Sciences. He has received says Eric Winer, MD, director of the available for clinical use in March. numerous accolades for his research, breast oncology center at Dana-Farber Marketing applications have been including the Lasker-DeBakey Clinical Cancer Institute in Boston, MA, who submitted to other regulatory agencies Medical Research Award. has treated about 40 patients with the around the world, including the Euro- pean Medicines Agency. ■ Harold Moses, MD, drug as part of clinical trials. received the AACR The drug was approved based on Award for Lifetime fi ndings from the EMILIA study, which Roswell Park Plans Achievement in randomly assigned 991 patients to National Services Cancer Research, receive ado-trastuzumab emtansine or honoring the lasting lapatinib (Tykerb; GlaxoSmithKline) Today, institutions that want to impact of his research and capecitabine (Xeloda; Roche/ provide cancer genomics typically and demonstrated commitment to prog- Genentech). Patients treated with must fi gure out for themselves how to ress against cancer, at the organization’s ado-trastuzumab emtansine had a collect and store samples, select gene annual meeting. median progression-free survival dura- targets, and use genetic analyses in The Hortense B. Ingram Professor of tion of 9.6 months compared with 6.4 treatment. So far, that has generally Molecular Oncology and director emeri- months in those treated with lapatinib meant that only the biggest centers tus of the Vanderbilt-Ingram Cancer and capecitabine. In addition, median provide routine genetic analyses for Center in Nashville, TN, Moses and his overall survival was nearly 6 months their cancer patients, and often only in team discovered that transforming longer in the ado-trastuzumab emtan- limited ways. growth factor-β is an inhibitor of normal sine group compared with the lapatinib- Roswell Park Cancer Institute in cell growth. plus-capecitabine group. Buffalo, NY, hopes to change that. The The fi rst ADC approved to treat institute has partnered with its Buf- Also at the AACR solid tumors, ado-trastuzumab emtan- falo neighbor, Computer Task Group, meeting, Robert C. or CTG, which provides electronic Young, MD, president sine selectively binds to HER2-overex- medical records technology, to help of RCY Medicine in pressing tumor cells. Its components Philadelphia, PA, include the monoclonal antibody tras- community hospitals and physician received the AACR tuzumab, the cytotoxic agent DM1, practices around the country collect, Margaret Foti Award and a linker that holds them together. manage, integrate, and analyze patient for Leadership and Extraordinary Once inside the cell, the molecule genetic information. Achievements in Cancer Research. breaks apart, interfering with the cell’s “These are challenges that every Young and his team generated the first ability to grow and divide. About 20% hospital in every area is addressing in ovarian cancer cell lines, standardized of breast cancer patients have HER2- the era of personalized medicine,” says the staging and grading of ovarian positive tumors. Candace Johnson, PhD, Roswell Park’s tumors, established prognostic factors Ado-trastuzumab emtansine “takes deputy director. for patients with ovarian cancer, and advantage of the tumor’s depend- The institute’s Center for Personal- developed a national strategy for coop- ence on HER2 as well as successfully ized Medicine (CPM) is just getting erative group clinical trials testing novel targeting the delivery of chemotherapy started, she says, but plans eventually treatment strategies. to HER2-positive cells,” explains to provide new biomarkers, therapies, Kimberly Blackwell, MD, the EMILIA and diagnostic tools.

366 | CANCER DISCOVERYAPRIL 2013 www.aacrjournals.org

NEWS IN BRIEF

One of its fi rst projects involves NOTED a screen for gene mutations in lung cancer. Testing for 6 common muta- • As the U.S. federal budget sequester tions today typically requires 6 assays, funding cuts kick in, the National Cancer each costing around $1,000, says Carl Institute (NCI) is among agencies that Morrison, MD, DVM, the new center’s are decreasing spending by about 5% for executive director. Roswell is working the fiscal year that started October 1. to win approval for a single panel that • Janssen Research & Development of would cover all 6, with 2 more assays Raritan, NJ, and Pharmacyclics of to be added soon. The institute has Sunnyvale, CA, announced that the U.S. not yet set a price for its assay, but it The Center for Personalized Medicine at Food and Drug Administration (FDA) will be far below the combined cost of Roswell Park Cancer Institute will help commu- gave “Breakthrough Therapy” designa- 8 separate ones, Morrison says. nity hospitals and physician practices around tions to their oral agent ibrutinib as a In the second quarter of this year, the country collect, manage, integrate, and monotherapy for 2 B-cell malignancies. analyze patient genetic information. It expects the CPM expects to launch its com- Ibrutinib, designed to target Bruton mercial venture with next-generation to launch its commercial venture by midyear with sequencing assays focused on decision- tyrosine kinase, is one of the first oncol- sequencing assays focused on thera- making for lung cancer. ogy drugs to receive a Breakthrough peutic decision-making for lung promising to truly delivering for Therapy designation, given on the basis cancer. Additional next-generation patients. That’s where Roswell Park of at least one clinically significant end- sequencing assays focused on helping point, such as substantial treatment can be at the forefront.” ■ doctors make diagnostic decisions effects in early clinical development. for some other cancers—possibly • The NCI released draft guidelines aimed melanoma and/or colorectal cancer— European Lead Factory to improve practices in the creation and could be ready by the fourth quarter. analysis of tests used for genomic- Roswell Park plans to offer its own Launches based classification of patients in clini- patients the same tests and services it The European Lead Factory, a cal trials. will provide commercially. public–private initiative for drug The institute will focus its efforts discovery, debuted in February and • The FDA approved the multikinase on mutations for which there is a tar- is now ramping up. Partners in the inhibitor Stivarga (regorafinib; Bayer geted drug available, Morrison empha- initiative—currently a consortium of HealthCare Pharmaceuticals) to treat sizes. It doesn’t make sense, he says, to 7 pharmaceutical fi rms, 10 small- to patients with advanced gastrointestinal generate information that doesn’t lead medium-size companies, and 13 aca- stromal tumors (GIST) whose tumors to better treatment. demic and nonprofi t participants—will cannot be removed surgically and who no The CPM has also launched a 3-part have access to approximately 500,000 longer respond to other drugs. translational research initiative. One chemical compounds and a leading- • Relative survival rates for patients with project aims to predict on a case-by- edge screening center with ultra-high- advanced renal cell carcinoma have not case basis whether anthracycline-based throughput robotics. improved in the era of targeted agents, or platinum-based chemotherapy During the 6-month ramp-up, according to data presented by Binay offers the best results with the fewest industry and academic researchers Shah, MD, of Saint Joseph Regional side effects in treating breast cancer. are contributing compounds and Medical Center in Lewiston, ID, at the A second effort will develop a diagnos- screening assays to the Lead Factory American Society for Clinical Oncology tic test for superfi cial bladder cancer, for validation and possible selection. Genitourinary Cancers Symposium in while a third will survey and collect “Once we’ve established our processes Orlando, FL, in February. tissues from 600 healthy volunteers to for selection and transfer of assays, we • In 2012, use and costs for cancer medica- identify western New York’s particular will recruit assays from contributing tions increased by 3.4% and 22.3%, healthcare needs. third parties outside the consortium,” respectively, in the United States, CTG has committed $2.5 mil- says Ton Rijnders, PhD, head of screen- reported Express Scripts of St. Louis, MO. lion to the center. New York State ing for the Lead Factory and scientifi c

chipped in $5.1 million to promote director of TI Pharma. A nonprofi t • A study by the National Foundation for American Policy revealed that among a economic development in the Buffalo based in Leiden, the Netherlands, group of 1,500 researchers at 7 leading area, and Roswell Park contributed TI Pharma provides oversight for U.S. comprehensive cancer centers, $16 million. the project. 42% are immigrants. The institute’s efforts are “extremely More than half of the compounds forward-looking,” comments Robert in the Lead Factory’s collection will • From 1989 to 2008, California’s tobacco B. Darnell, MD, PhD, senior physician come from participating pharmaceuti- control program cost $2.4 billion but at The Rockefeller University in New cal companies, including AstraZeneca reduced health care costs by $134 bil- York City and president and scientifi c AB in Sweden, Bayer Pharma AG in lion, said researchers at the University of director of the nonprofi t New York Germany, H. Lundback A/S in Den- California, San Francisco (PLoS ONE Genome Center. “It will take years of mark, Johnson & Johnson’s Janssen 2013;8:e47 145). work to take genomics from being Pharmaceuticals in Belgium, Merck

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Roswell Park Plans National Services

Cancer Discovery 2013;3:366-367. Published OnlineFirst March 7, 2013.

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