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September 2014PDF

Breast Cancer 
Results from CLEOPATRA Phase III Trial Show Perjeta Increased OS 15.7 Months

Final phase III trial results showed that adding Perjeta to Herceptin and docetaxel chemotherapy increased overall survival to over four-and-a-half years in patients with previously untreated HER2-positive metastatic breast cancer.

Data from the CLEOPATRA study showed that the addition of Perjeta (pertuzumab) increased median overall survival 15.7 months compared to Herceptin (trastuzumab) and docetaxel alone—to 56.5 and 40.8 months, respectively. 

The data were presented at the Presidential Symposium at the European Society for Medical Oncology Congress in Madrid. 

Pancreatic Neuroendocrine Tumors

Afinitor Increases Overall Survival To 3.5 Years in Phase III Trial

An analysis of mature overall survival data from a phase III trial showed that Afinitor increased median overall survival by 6.34 months compared to placebo, for a total of over 3.5 years in patients with well-differentiated advanced and progressive pancreatic neuroendocrine tumors.

Overall survival was a secondary endpoint of the trial. The findings were presented at the European Society for Medical Oncology Congress in Madrid. Results from the primary analysis, which focused on progression-free survival, in which Afinitor (everolimus) more than doubled median PFS compared to placebo, were previously published in the New England Journal of Medicine.

Non-Small Cell Lung Cancer

Merck Serono Cancels Tecemotide Program In NSCLC, Including Two Phase III Trials

Merck Serono will discontinue its worldwide clinical development program of MUC1 antigen-specific immunotherapy tecemotide as a monotherapy in stage III non-small cell lung cancer. This includes the phase III START2 and INSPIRE studies.

The decision comes after a planned analysis of EMR 63325-009, a randomized, double-blind, placebo-controlled phase I/II study in Japanese patients with stage III unresectable, locally advanced NSCLC. Patients had received concurrent or sequential chemoradiotherapy with a minimum of two cycles of platinum-based chemotherapy and radiation dose greater than or equal to 50 Gy.

Multiple Myeloma
Phase III Trial: Panobinostat Increases PFS by Four Months
Gastric Cancer
Phase III Cyramza Trial Meets OS Primary Endpoint
Colorectal Cancer
Phase III Xilonix Study Halted Following Unscheduled Analysis
Ovarian Cancer
Cediranib/Olaparib Combination Nearly Doubles PFS in Phase II
Chemotherapy
Fidaxomicin for CDI Therapy More Cost-Effective Than Vancomycin 
NCI CTEP-Approved Trials for the Month of September
FDA News

  • Keytruda granted accelerated approval in metastatic melanoma

  • FDA approves new indication for Xtandi in prostate cancer

  • FDA removes clinical holds for two agents: ipafricept and PEGPH20

  • Soligenix Inc. reaches agreement with FDA on phase III trial design

20141001 - Oct. 1, 2014
ISSUE 36 – SEPT. 26, 2014PDF



Colorado Institutions Vying to Build First Carbon Ion Center in the U.S.

The University of Colorado and Colorado State University are vying to become the first institution to build a carbon-ion radiotherapy research and treatment facility in the U.S. The treatment modality is available in Europe and Japan.

Officials at the two universities are exploring the feasibility of building a $300 million research and treatment facility at the University of Colorado Anschutz Medical Campus in Aurora.

Their first step is to conduct a $200,000 feasibility study for the project.

Conversation with The Cancer Letter
Pat White: NIH Funding “Our Only Concern”

A lobbying campaign will make an effort to secure an immediate, significant funding increase for NIH.

The effort, called ACT for NIH: Advancing Cures Today, seeks to bring together patients, scientists, advocates, and lawmakers on both sides of the aisle. Their objective is to demonstrate the impact of a decade of clamping down on NIH funding. Adjusted for inflation, NIH receives nearly 25 percent less funding than it did in 2003.

Gonzalez-Angulo Found Guilty in MD Anderson Poisoning Case

HOUSTON—Ana Maria Gonzalez-Angulo, a 43-year-old breast cancer specialist at MD Anderson Cancer Center, was found guilty of poisoning her lover, George Blumenschein, another medical oncologist at MD Anderson.

A jury at the Harris County 248th District Criminal Court found Gonzalez-Angulo guilty of aggravated assault Sept. 26. The court immediately went into the penalty phase of the proceedings.

Guest Editorial
“Gizmo Idolatry” and Marketing Da Vinci’s Radical Robot

In America, cutting-edge inventions are seen as the gateway to the future. However, the hazard of credulously accepting new technology into medical practice was warned against in a 2008 Journal of the American Medical Association editorial “Gizmo Idolatry.”

The term “gizmo idolatry” describes the conviction that a high-tech approach is better than a low-tech approach, even if there’s no evidence to support that view. A glaring example of medical “gizmo idolatry” is the da Vinci Surgical System. Without credible data to prove its safety and benefit in complex surgeries, this costly robotic machine has been promoted into near ubiquitous use in hospitals across the nation. 

MD Anderson Expands Reach Into Florida, Ohio

Two institutions said they are in varying stages of completing partnerships with MD Anderson Cancer Center.

The two deals are a part of an expansion strategy that essentially means that the MD Anderson logo can light up almost anywhere, establishing the Houston-based cancer center as a potential competitor to almost any cancer center in the U.S.

NCI Starts “Exceptional Responders” Study

NCI has launched a pilot study to investigate the molecular factors of tumors associated with exceptional treatment responses of cancer patients to drug therapies.

The Exceptional Responders Initiative seeks to identify the molecular features of tumors that predict whether a particular drug or class of drugs will be beneficial. 

photoIn Brief

  • Doug Ulman named CEO of Pelotonia

  • Margaret Foti honored by Friends of Cancer Research

  • Wilshire Oncology Medical Group joins City of Hope

  • The West Clinic receives National Committee for Quality Assurance recognition

  • FDA awards Critical Path Institute $2.1 million

  • Beth Israel Deaconess Medical Center and Cancer Genetics Inc. enter collaboration

  • FASEB publishes factsheet on federal research funding by congressional district

  • Lisa Stockmon named City of Hope chief communications officer 

  • FDA names recipients Drug Shortage Assistance Award

  • European Head and Neck Society calls for EU program

  • QVC and Fashion Footwear Association of New York present $240,000 to University of Pittsburgh Cancer Institute

20140926 - Sep. 26, 2014
ISSUE 35 – SEPT. 19, 2014PDF



DePinho Will Not Meet With AAUP In Probe of Tenure Denial Dispute 

MD Anderson Cancer Center President Ronald DePinho declined to meet with the investigation committee dispatched by the American Association of University Professors to his institution Thursday.

“We will not personally meet with representatives of a non-governing entity conducting an unauthorized investigation with a pre-determined outcome.” DePinho wrote in a Sept. 17 email to MD Anderson faculty and staff.

 

Officials: Poisoning Unrelated to MD Anderson;

Critics Allege Dysfunction in Handling of Affair

Images of the gleaming buildings and the distinctive logo of MD Anderson Cancer Center have been flashing on television screens and appearing on pages of respectable newspapers and scandal sheets alike.

The reason has nothing to do with the Moon Shots aimed at curing cancers. Rather, the name of the venerable cancer center is being dragged through the mud because one of its doctors stands accused of trying to poison another.

Sept. 9 NCAB Meeting
Varmus: Expect Another CR For Funding The NIH Through Mid-December

NCI Director Harold Varmus said Congress is moving slowly on appropriations bills, and a continuing resolution lasting until December is the best that can be expected in the short term.

“Depending on the outcome of the election in November, there may be an interest among the Republicans that if they regain the Senate that this should be postponed until after they’re back in charge in both sides of the bicameral legislature,” Varmus said at the Sept. 9 meeting of the National Cancer Advisory Board.

AACR 2014 Cancer Progress Report:

More Federal Funds Needed

The American Association for Cancer Research published its 2014 Cancer Progress Report Sept. 16, highlighting the need for greater federal investments in biomedical research. 

The report is a “comprehensive educational tool that chronicles the progress that has been made against cancer…and calls on the administration and Congress to prioritize the growth of the NIH and NCI budgets,” according to AACR.

Funding Opportunities
AACR Accepting Submissions for Two Dream Team Grants

The American Association for Cancer Research is accepting submissions of ideas to two dream team grants: one offering $20 million for lung cancer research, and one for $6 million for ovarian cancer research.

Funding for the lung cancer research grant will be provided by Stand Up To Cancer, the American Cancer Society and Bristol-Myers Squibb. The ovarian cancer research grant provides funding over three years, and is sponsored by Stand Up To Cancer, the Ovarian Cancer Research Fund, the Ovarian Cancer National Alliance, and the National Ovarian Cancer Coalition.

photoIn Brief

  • David Tweardy named head of internal medicine at MD Anderson

  • Dan Glickman named to ACS Cancer Action Network board of directors

  • Memorial Sloan Kettering begins construction on 285,000-square-foot outpatient center in Middletown, N.J.

  • Boehringer Ingelheim and CureVac announce collaboration.

  • Soligenix Inc. reaches phase III protocol agreement with FDA

  • Sutro Biopharma and Merck KGaA form ADC collaboration

  • Denovo Biopharma acquires enzastaurin rights from Eli Lilly & Co. 

  • Leukemia and Lymphoma Society partners with OncoPep

20140919 - Sep. 19, 2014