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Published OnlineFirst December 22, 2016; DOI: 10.1158/2159-8290.CD-NB2016-163

NEWS IN BRIEF

PEOPLE Project GENIE Goes physician-scientist at Memorial Sloan Kettering Cancer Center (MSKCC) in Public New York, NY, Sawyers chairs the Pro- Steven K. Libutti, ject GENIE steering committee. “The MD, was appointed The American Association for Cancer d irector of Rutgers Research’s (AACR) Project Genom- dataset from GENIE will provide more Cancer Institute of ics Evidence Neoplasia Information robust numbers on how common such New Jersey in New Exchange (GENIE) released almost mutations are and how they are dis- Brunswick, effective 19,000 deidentifi ed genomic records tributed across different histologies.” January 10. He will also collected from patients with cancer who Size is just one element that sets serve as vice chancel- were treated at one of eight renowned Project GENIE apart from other data- lor for cancer programs for Rutgers medical centers. One of the largest pools sharing initiatives. “There are already Biomedical and Health Sciences at Rutgers of genomic information ever made pub- a lot of data publicly accessible from University. He replaces Bruce G. Haffty, MD, licly accessible, it comprises 59 types of TCGA [The Cancer Genome Atlas], who had been serving as interim director. cancer, including data from more than ICGC [International Cancer Genome Previously, Libutti served as director 3,000 patients with lung cancer, 2,000 Consortium], and a few other sources,” for the Montefiore Einstein Center for patients with breast cancer, and 2,000 Sawyers said. “TCGA, for example, is Cancer Care in New York, NY. A surgical on- patients with colorectal cancer. a database that has comprehensive cologist, he is an internationally known ex- The data can be accessed via cBio- research-grade genomic data on the pert in endocrine surgery and the Portal (www.aacr.org/genie/data) or tumors together with some clinical management of neuroendocrine tumors. downloaded from Sage Bionetworks data available at the time the speci- (www.synapse.org/genie), which logged mens were submitted for sequenc- David A. Tuveson, the data provenance, performed ing. GENIE is different because the MD, PhD, became quality assurance, and merged and genomic and clinical data are obtained director of the Cold from patients who are part of routine Spring Harbor Labo- harmonized fi les from the various practice, and the database is ratory Cancer Center institutions. ‘living,’ in that additional data on these in New York, where he Launched in late 2015, Project patients can be collected over time.” had been directing the GENIE is an international effort to

Cold Spring Harbor Laboratory The newly released data does not yet Cancer Therapeutics aggregate and link clinical-grade, Initiative, in late Nov ember. He succeeds next-generation sequencing data from include information on how patients Bruce W. Stillman, PhD, who served as the patients’ tumors with some limited fared or their disease course, but these center’s director for 25 years. Tuveson’s clinical details, such as whether the details will eventually be added for research focuses on finding methods to sample was taken from a primary or select groups of patients. detect pancreatic cancer earlier in the metastatic lesion. By combining data Project GENIE was pioneered by disease course and designing novel thera- from multiple institutions, research- researchers at Dana-Farber Cancer peutic approaches, based in part on pan- ers have access to larger cohorts Institute (Boston, MA); Gustave Roussy creatic organoid technology, which he has of patients, providing the greater Cancer Center (Villejuif, France); The pioneered. He also serves as the director statistical power that would allow Center for Personalized Cancer Treat- of research for the Lustgarten Foundation, them to more quickly draw clinically ment (Utrecht, the Netherlands); Sidney which funds pancreatic cancer research. meaningful conclusions and advance Kimmel Comprehensive Cancer Center cancer research. For example, the data at Johns Hopkins (Baltimore, MD); Stanton L. Gerson, could be mined to validate gene signa- MSKCC; Princess Margaret Cancer MD, began a 2-year tures of drug response or prognosis; Centre (Toronto, Canada); The University term as president of identify and expand populations of of Texas MD Anderson Cancer Center the Association of patients who might benefit from (Houston); and Vanderbilt-Ingram Can- American Cancer Insti- drugs approved by the FDA for other cer Center (Nashville, TN). tutes, which repre- purposes; and discover new drug tar- Eager to expand the Project GENIE sents 96 academic and registry, the consortium is accepting University Hospitals University gets and biomarkers. Suffi cient sample freestanding cancer applications from other cancer centers research centers in the United States and sizes will enable greater understanding that would like to participate. For more Canada, at the organization’s annual meeting of rare malignancies. information, email [email protected]. last fall. Gerson serves as the director of the “While the research community –Suzanne Rose ■ NCI-designated Case Comprehensive has gained substantial knowledge Cancer Center and the University Hospital about many common mutations Seidman Cancer Center, both in Cleveland, that drive some types of cancers, we “Cures” Act Signed OH. A highly regarded investigator, he has have a dearth of information on the into Law been involved in research programs related rarer ones, whose signifi cance we are to stem cells, hematologic malignancies, and slowly uncovering,” Charles Sawyers, On December 13, the 21st Century developmental therapeutics. MD, told Cancer Research Catalyst, the Cures Act (Cures)—the product of more AACR’s offi cial blog (blog.aacr.org). A than 2 years of intensive discussions

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NEWS IN BRIEF

in both the House and Senate, plus The American Association for Can- tremendous outreach and educational cer Research also hailed Cures’ success- efforts by medical researchers and patient ful passage, while emphasizing that the advocates—fi nally became law. funding it provides should supplement, “It’s a good day to see us doing not supplant, regular and robust appro- our jobs,” President Barack Obama priations for the NIH. –Alissa Poh ■ remarked at the signing ceremony, refer- ring to the overwhelming bipartisan support for this landmark legislation: Abemaciclib Shows The House voted 392 to 26 in favor of Promise for Early Breast Cures; the Senate 94 to 5. “Today, we Cancer Buchanan 2016 ©MedMeetingImages/Todd are bringing to reality the possibility Sara Hurvitz, MD, presents preliminary results of new breakthroughs for some of the Treatment with the CDK4/6 inhibitor of a phase II study of abemaciclib for the treat- greatest health challenges of our time,” abemaciclib (Eli Lilly), alone or in combi- ment of women with hormone receptor–positive, Obama added. nation with endocrine therapy, signifi - HER2-negative breast cancer. “God willing, this bill will save lives,” cantly lowered expression of Ki67—a key said Vice President Joe Biden. He spoke marker of cell proliferation—in women The majority of patients who took the of “injecting a sense of urgency” into with hormone receptor (HR)–positive, combination therapy also experienced the fi ght against cancer, and how HER2-negative breast cancer, accord- shrinkage of their tumors, said Sara Cures will help “enhance prevention ing to preliminary data from the phase Hurvitz, MD, medical director of the and detection efforts in every commu- II neoMONARCH trial. The find- University of California, Los Angeles, nity regardless of ZIP code, bringing ings, presented during the 2016 San Jonsson Comprehensive Cancer Center us closer to the day when there are vac- Antonio Breast Cancer Symposium in Research Unit, who presented the data. cines for all kinds of cancer, just as we Texas, December 6–10, suggest that Reduced Ki67 expression also have them for measles or mumps.” CDK4/6 inhibition, which is already appeared to trigger infi ltration of anti- Through Cures, the NCI will receive used to treat advanced disease, may be tumor immune cells, noted Hurvitz. $1.8 billion over 7 years, including effective for neoadjuvant treatment of Tissue analysis after 4 months of treat- $300 million in the current fi scal year, early breast cancer. ment showed that patients who took to fund various projects of the Beau Estrogen stimulates increased activity abemaciclib plus anastrozole showed Biden Cancer Moonshot. A total of of CDK4/6, which plays an important an increase in cytotoxic/suppressor $3 billion will be funneled to two role in regulating cell-cycle progression. T cells in their tumors, but no increase other signature Obama admin- The neoMONARCH investigators in regulatory T cells, which are thought istration research programs—the hypothesized that inhibiting CDK4/6 to dampen the immune response. Precision Medicine Initiative and would help slow cell cycling, as meas- This is the fi rst large study to show the BRAIN Initiative. An Oncology ured by changes in Ki67 expression. that CDK4/6 inhibition may be effective Center of Excellence will be created Earlier studies have shown that in neoadjuvant treatment of early-stage at the FDA, and the agency’s hiring lowered Ki67 expression after 2 weeks breast cancer, she said. Currently, one authority will be expanded to better of treatment may be predictive of CDK4/6 inhibitor, palbociclib (Ibrance; recruit and retain staff members with improved disease-free survival. Pfi zer), is approved for initial endocrine- the required scientifi c expertise. Cures In the proof-of-concept study, based therapy to treat advanced or will also establish a review pathway 223 postmenopausal women were metastatic disease. Another, ribociclib for the FDA to validate biomarkers randomly assigned to receive either (), is under investigation and and other drug development tools, endocrine therapy (anastrozole), was granted Breakthrough Therapy besides reauthorizing a priority review abemaciclib, or both for 2 weeks; all of status earlier this year. voucher program to spur new thera- the patients then received both drugs The data also suggest that abemaci- pies for rare pediatric diseases. for 14 weeks, followed by optional clib may be less toxic than palbociclib, Ronald DePinho, MD, president of surgery. Researchers analyzed biopsies said Hurvitz. Palbociclib is typically The University of Texas MD Anderson taken from evaluable patients in each given on a 3 weeks on/1 week off regi- Cancer Center in Houston, called the arm before and after the fi rst 2 weeks men to allow neutrophils to recover, legislation “transformative,” saying it of treatment. The results showed sig- but experts worry that the medication “provides rocket fuel . . . to accelerate the nifi cantly reduced Ki67 expression in break could trigger a rebound in cell development of new lifesaving advances 107 patients who received abemaciclib cycling, leading to resistance. In the to help us write [cancer] into the his- or the combination compared with 54 neoMONARCH trial, abemaciclib was tory books.” Megan Gordon Don, vice patients who received only anastrozole. taken continuously with a relatively low president of Government Affairs and In particular, reduced Ki67 expression rate (8.2%) of grade 3 or 4 neutropenia. Advocacy at the Pancreatic Cancer was observed in significantly more The investigators are continuing Action Network, added that with Cures, patients who took abemaciclib or the to evaluate pathologic responses and “important work on immunotherapy, combination therapy (59% and 66%, long-term outcomes in an effort to personalized medicine . . . will move respectively) compared with those discover more about how CD4/6 forward quickly to benefi t patients.” who took anastrozole alone (15%). inhibitors work, said Hurvitz.

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''Cures'' Act Signed into Law

Cancer Discov 2017;7:118-119. Published OnlineFirst December 22, 2016.

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