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FDA Grants Genentech’s Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin® (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

West Clinic Researchers Present Findings at 2013 American Society for Clinical Oncology (ASCO) Meeting

The West Clinic, the Mid-South’s premier cancer center and world-class center of excellence in medical oncology, hematology, oncologic imaging, clinical research and other advanced medical care, recently announced five of its physician-researchers will participate in ten presentations at the 49th Annual American Society of Clinical Oncology (ASCO) Meeting to be held May 31-June 4, 2013 in Chicago, IL at the McCormick Palace. Over 30,000 members of the oncology community from across the nation and around the world are expected to attend the five-day international scientific and educational oncology conference. This year’s theme is “Building Bridges to Conquer Cancer.”

The West Clinic’s findings, which focus on leading-edge treatments for non-small cell lung cancer, colorectal cancer, lymphoma, and breast cancer, were selected by a highly competitive peer-review process.

“The West Clinic continues to further its research mission with a strong showing at ASCO, the world’s premier oncology meeting,” according to Lee S. Schwartzberg, MD, FACP, Medical and Research Director, The West Clinic; President, ACORN Research, LLC; and Chief, Division of Hematology/Oncology and Professor of Medicine, University of Tennessee Health Science Center. “Over 5000 abstracts from around the world were submitted this year. Our invitation to present four out of five West Clinic/ACORN abstracts reflects our reputation for being a major oncology research center. We are also pleased that our Chief Fellow, Dr. Jessica Snider, is first author on an important neo-adjuvant breast cancer trial that she will present.”

Landmark research has been a heritage of The West Clinic and its continued commitment to a robust program is strong with participation in approximately 40 open studies, 12 of which are Phase I. West Clinic physicians conduct a broad spectrum of clinical research trials ranging from Phase I to Phase IV studies in collaboration with major pharmaceutical companies, the National Cancer Institute, cooperative groups, and its own investigator initiated trials funded by grants. West Clinic has one of the most advanced research programs of its kind in the country and played a major role in the development of new drugs for breast cancer, colon cancer, lung cancer, prostate cancer, lymphoma, and many other diseases.

“This year’s theme Building Bridges to Conquer Cancer parallels our vision and unique collaboration with the University of Tennessee Health Science Center, Methodist Healthcare, and researchers across the country through ACORN Research, further positioning West Clinic as an innovative leader, exploring new cancer-fighting treatments, and saving more lives,” stated Dr. Schwartzberg.

The following West Clinic physicians contributed to ASCO presentations.

GENERAL POSTER PRESENTATIONS

  1. Dr. Lee Schwartzberg: Serum and tumor biomarkers to predict outcome in the eLung trial, a multicenter, randomized phase IIb study of standard platinum doublets (PD) plus cetuximab (CET) as first-line treatment of advanced non-small cell lung cancer (NSCLC). http://abstracts2.asco.org/AbstView_132_110479.html
  2. Dr. Lee Schwartzberg; Dr. Obiageli Ogbata: Real-world symptom burden and early treatment discontinuation in first-line metastatic breast cancer (MBC). http://abstracts2.asco.org/AbstView_132_110594.html
  3. Dr. Lee Schwartzberg: From Bayesian modeling to genomic mapping: Biologic validity of predictive single nucleotide polymorphism networks for chemotherapy-related side effects. http://abstracts2.asco.org/AbstView_132_114956.html
  4. Dr. Lee Schwartzberg: Phase I/II study of neoadjuvant carboplatin, eribulin mesylate, and trastuzumab (ECH) for operable HER2 positive (HER2+) breast cancer. http://abstracts2.asco.org/AbstView_132_110308.html
  5. Dr. Lee Schwartzberg: Analysis of KRAS/NRAS mutations in PEAK: A randomized phase II study of FOLFOX6 plus panitumumab (pmab) or bevacizumab (bev) as first-line treatment (tx) for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC). http://abstracts2.asco.org/AbstView_132_116726.html
  6. Dr. Lee Schwartzberg: Initial results from the 21-gene breast cancer assay registry: A prospective observational study in patients (pts) with ER+, early-stage invasive breast cancer (EBC). http://abstracts2.asco.org/AbstView_132_113096.html
  7. Dr. Lee Schwartzberg: Phase II study of lapatinib in combination with vinorelbine, as first- or second-line therapy in women with HER2-overexpressing metastatic breast cancer. http://abstracts2.asco.org/AbstView_132_115057.html
  8. Dr. Jessica Snider: Pathologic complete response (pCR) with weekly nanoparticle albumin bound (nab-P) plus carboplatin (C) followed by doxorubicin plus cyclophosphamide (AC) with concurrent bevacizumab (B) for triple-negative breast cancer (TNBC). http://abstracts2.asco.org/AbstView_132_117576.html
  9. Dr. Brad Somer: Randomized phase II study with window-design to evaluate anti-tumor activity of the survivin antisense oligonucleotide (ASO) ly2181308 in combination with docetaxel for first-line treatment of castrate-resistant prostate cancer (CRPC). http://abstracts2.asco.org/AbstView_132_108714.html
  10. Dr. Daruka Mahadevan: Genetic and cytokine profiles associated with symptomatic stage of CLL. http://abstracts2.asco.org/AbstView_132_113916.html

PUBLICATIONS ONLY

  1. Dr. Lee Schwartzberg: A phase IIb trial of coix seed injection for advanced pancreatic cancer. http://abstracts2.asco.org/AbstView_132_115489.html
  2. Dr. Daruka Mahadevan: Phase Ib study of safety, tolerability, and efficacy of R1507 a monoclonal antibody to IGF-1R in combination with multiple standard chemotherapy regimens in patients with advanced solid malignancies. http://abstracts2.asco.org/AbstView_132_110601.html

Source: PR Newswire

Presage Biosciences Announces First Patient in Clinical Trial of CIVO™ Precision Oncology

Presage Biosciences, a leader in precision oncology, recently announced the initiation of a clinical trial and the first patient use of CIVO™, the company’s precision oncology platform designed to improve treatment decisions for cancer patients. The single arm, non-therapeutic, observational study, being conducted at Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, is intended to evaluate the feasibility of Presage’s CIVO in assessing lymphoma response to multiple microinjected candidate chemotherapy agents.

“Results from this initial study will assess the potential of CIVO to guide personalized clinical treatment for lymphoma patients,” said Richard Klinghoffer, Ph.D., Vice President of Research & Development at Presage Biosciences. “CIVO is designed to enable analysis of the potential therapeutic effect of multiple drugs simultaneously following precise delivery of each agent to a distinct location on the patient’s tumor. By employing this technology we hope to discern which drugs induce a localized anti-tumor response, indicative of therapeutic effect, prior to systemic administration of chemotherapy.”

The trial will enroll up to 12 patients with either newly diagnosed lymphomas who have not yet received treatment or relapsed lymphoma previously treated with one or more agents in the R-CHOP chemotherapy regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). Patients’ lymphomas will be microinjected with up to four drugs comprising rituximab, vincristine, doxorubicin and prednisolone. Twenty-four hours later, the lymph node of interest will be removed and analyzed for target engagement and tissue response.

More information about this study, including additional eligibility criteria and contact information, can be found on clinicaltrials.gov. Study participants are not expected to benefit medically from participation or to directly benefit from the data generated in this feasibility study. None of the data will be released to the patient or treating physician in a manner that could be used to make treatment decisions. Patients may contact Jennifer Lindquist, Patient Care Coordinator / Lymphoma – Intake Office at Seattle Cancer Care Alliance, jlindqui@seattlecca.org or 206-288-6202 for more information.

“When a patient learns they have cancer, they want effective drugs that cause as little toxicity as possible. An expert panel from the American Society for Clinical Oncology found that previous attempts to predict cancer sensitivity to therapeutic agents using cancer cells grown in tissue culture dishes have not helped the way we hoped they would,” said Oliver W. Press, M.D., Ph.D., a member of the Clinical Research Division at the Fred Hutchinson Cancer Research Center, Professor of Medicine at the University of Washington and the Principal Investigator for the study. “Oncologists and patients are eager for a reliable method to assess cancer drug sensitivity or resistance in the patient’s own tumor. We look forward to evaluating the Presage’s CIVO precision oncology platform and gathering patient data to evaluate the potential of this innovative approach.”

Source: Presage Biosciences

Cardiac Biomarkers May Indicate Heart Risks in Child Cancer Survivors

A new Miller School study has identified two cardiac biomarkers that could be early indicators of heart damage in childhood cancer survivors. The study, another major step in determining cardiac damage in childhood cancer patients, was led by Steven E. Lipshultz, M.D., professor and chair of pediatrics and executive associate dean for child health.

Rosetta Genomics and UC Davis Researchers to Develop and Validate microRNA Biomarker to Predict Response to Neoadjuvant Chemotherapy in Bladder Cancer

Rosetta Genomics, a leading developer and provider of microRNA-based molecular diagnostic tests, announces it has entered into a collaboration with the University of California, Davis (“UC Davis” or the “University”) to develop and validate a microRNA profile for muscle-invasive bladder cancer (MI-BC) that is predictive of patient response to neoadjuvant chemotherapy. The collaboration allows for UC Davis researchers to continue using Rosetta’s platforms and microRNAs to further discover new biomarkers and validate their results.