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ISSUE 13 – APRIL 3, 2015PDF

Over 48 Hours, Power Shifts at NCI, ACS, Dana-Farber and MD Anderson

Over the first two days in April, massive leadership changes occurred at top institutions in cancer research:

• On April 1, the top job at NCI switched from Harold Varmus to Douglas Lowy, with the Lowy being formally named acting director.

• On April 1, Edward Benz announced his plans to leave presidency at Dana-Farber Cancer Institute, and the institution’s board began the search for his successor.

• On April 2, the American Cancer Society announced that the job of CEO would go to former Johnson & Johnson executive Gary Reedy.

• On April 2, the UT System announced that Lynda Chin will be vacating her jobs as head of genomic medicine and scientific director of a research institute she co-founded. Chin, who is married to MD Anderson President Ronald DePinho, came to Houston from Dana-Farber as a team in 2011.

Resolving Disputes in Precision Medicine: The Question of CYP2D6 Remains Open

What does it take to declare that a scientific dispute is resolved? 

A long-running argument over the role of a biomarker in the treatment of breast cancer illustrates a challenge that runs through the heart of precision medicine: the absence of mechanisms for resolving disagreements between scientists.

The story of CYP2D6, a mutation that may (or may not) predict the manner in which the patient metabolizes the cheap, widely used drug tamoxifen, is of the sort that makes insiders shake their heads.

The question is relevant to an estimated 150,000 newly diagnosed estrogen receptor-positive breast cancer patients a year in the U.S. alone.

A Biomarker Court? Who Should Decide?

Answers from: Carmen Allegra, Lisa McShane, Robert Cook-Deegan, Barnett Kramer, Frances Visco, and FDA

No pharma company is clamoring to get a response to the question of significance of CYP2D6. 

Since an estimated 7 percent of newly diagnosed breast cancer patients are poor metabolizers of tamoxifen, perhaps as many as 93 percent are good candidates for receiving this cheap generic drug. 

Cold Spring Harbor Laboratory And North Shore-LIJ to Form $120 Million Collaboration

Two New York institutions—Cold Spring Harbor Laboratory and the North Shore-LIJ Health System—announced a $120 million cancer research collaboration on April 2.

The collaboration aims to develop a clinical cancer research unit at the North Shore-LIJ Cancer Institute’s headquarters in Lake Success, N.Y., support early-phase clinical studies, and recruit and train clinician-scientists.

North Shore-LIJ and CSHL will continue as independent organizations governed by their respective boards of trustees. The sources of funds for the collaboration were not disclosed.

In Brief

  • Lewis Cantley to Deliver Takamatsu Lecture at AACR Annual Meeting

  • Lucille Adams-Campbell to Deliver Minorities in Cancer Research Lecture at AACR Annual Meeting

  • Robert Gentleman appointed vice president of computational biology at 23andMe Inc.

  • Aleksandar Zafirovski named associate director for administration for Lurie Cancer Center at Northwestern University

  • Scripps Clinic Medical Group acquires three radiation oncology services

  • Aeterna Zentaris to transfer library of 100,000 compounds to center at Medical University of South Carolina

  • GlaxoSmithKline to establish third global center for vaccine research in Rockville, Md.

Drugs and Targets

  • FDA approves Jadenu, an oral formulation of Exjade

  • FDA grants priority review to Kyprolis

  • FDA updates label for Zytiga plus prednisone in metastatic castration-resistant prostate cancer

  • MD Anderson Cancer Center and Astellas Pharma Inc. sign option agreement for AML research

  • Eli Lilly and OncoMed Pharmaceuticals to evaluate combination of demcizumab and Alimta

  • Merck and Syndax Pharmaceuticals to evaluate combination of Keytruda and entinostat

  • Intrexon Corporation and Merck Serono to collaborate on CAR-T cancer therapies

20150403 - Apr. 3, 2015
March 2015PDF

 Leukemia

Phase III Trial of Imbruvica Unblinded Following Significant Increase in PFS

An independent data monitoring committee recommended unblinding the phase III HELIOS trial, which is evaluating Imbruvica in combination with bendamustine and rituximab in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, following clinically meaningful and statistically significant treatment benefit.

The study has met its primary endpoint in extending progression-free survival. The safety profile of Imbruvica combination was consistent with prior clinical experience. Imbruvica is jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc.

HELIOS, an international, placebo-controlled trial enrolled 578 CLL or SLL patients who had received at least one line of prior systemic therapy. Patients were randomized to receive either Imbruvica orally once daily in combination with six cycles of BR; or placebo orally once daily with six cycles of BR, with treatment continuing until disease progression or unacceptable toxicity.

 Prostate Cancer

Provenge Immune Response Continued For Two Years in Phase II Study in BRPC

Preliminary results from the phase II STAND trial showed a robust immune response with Provenge (sipuleucel-T) that continued two years after completing treatment in men with biochemically-recurrent prostate cancer. 

The STAND study is a randomized trial consisting of two patient study groups. One group completed Provenge two weeks before initiation of androgen deprivation therapy and the second received Provenge three months after the start of ADT.

Preliminary results from STAND indicate that immune responses were observed in both study arms and suggest there may be a greater cellular immune response in patients who received Provenge prior to ADT compared with those who received Provenge following three months of ADT. Humoral immune responses were observed and similar between both treatment arms.

 Drugs and Targets

FDA Grants Accelerated Approval to Farydak for Patients with Multiple Myeloma

FDA granted accelerated approval to Farydak (panobinostat) for the treatment of patients with multiple myeloma.

An improvement in survival or disease-related symptoms has not yet been established for Farydak. The drug’s sponsor, Novartis Pharmaceuticals, is required to conduct confirmatory trials to verify and describe the clinical benefit of Farydak. FDA had previously granted Farydak priority review and orphan product designation.

Farydak inhibits histone deacetylases, which may slow the over-development of plasma cells in multiple myeloma patients or cause these cells to die. Farydak is the first HDAC inhibitor approved to treat multiple myeloma. 

Also: FDA approves Unituxin, the EU approves Jakavi, and more

 Soft Tissue Sarcoma
Phase III Halaven Trial Shows Extended OS over Dacarbazine
 Brain Cancer
Study Shows 73% Survival at Three Years by Combining Radiation Therapy and Chemotherapy
 Myelofibrosis
Pacritinib Phase II Study Shows Reduction in Spleen Volume
 NCI CTEP-Approved Trials for the Month of March
20150331 - Mar. 31, 2015
ISSUE 12 – MARCH 27, 2015PDF

“All Pull; No Push”—Varmus Describes his Reasons for Leaving In Farewell Town Hall

In a farewell town hall meeting March 24, NCI Director Harold Varmus reflected on statements he made during his first day on the job, July 12, 2010, summarizing the proceeding four-and-three-quarter years; listing goals met and lamenting work left unfinished.

After Varmus steps down March 31, he will be replaced by Deputy Director Douglas Lowy, who will become the acting director.

Varmus’s remarks ranged from his reasons for leaving NCI—“All pull; no push”—to the accomplishments of the institute during his tenure, and lessons learned from obstacles unforeseen.

He discussed his Provocative Questions initiative and sequestration; the RAS initiative and the Frederick National Lab; as well as the formation of the National Clinical Trials Network and the completion of the National Lung Screening Trial.

Guest Editorial

How the Lung-MAP Clinical Trial is Responding to Rapidly Changing Science

By Roy S. Herbst, David Gandara and Vassiliki Papadimitrakopoulou

When the Lung Master Protocol clinical trial (Lung-MAP or S1400) (1) was launched in June 2014, the goal of this first-of-its kind trial was simple: find effective treatments for seriously ill patients suffering from a specific type of lung cancer.

Lung-MAP is unique—a biomarker driven, multi-drug, multi-arm, study design, using a targeted screening approach, with state-of-the-art genomic profiling of neoplastic cells to match patients with sub-studies testing investigational new drugs and immunotherapies, based on their unique tumor profiles.

Seventeen Percent of MD Anderson Faculty Signed Petition Disagreeing with Faculty Senate Executive Committee

About 17 percent of the faculty members at MD Anderson Cancer Center signed a petition that disagreed with the institution’s Faculty Senate in its efforts to step in and improve morale at the Houston-based institution.

The Faculty Senate recently sent out a letter requesting that the UT System officials and the Board of Regents “provide guidance” to the MD Anderson administration “in establishing milestones and timelines to implement measures to improve the morale of the faculty and the general health of the Institution.”

 

Republican Budgets Propose $5 Trillion Cut, On Top of Sequestration, Through 2025

The Senate passed its 2016 budget early Friday morning in a marathon voting session—an event called “vote-a-rama” in Washington-speak—that split along party lines with a 52-46 Republican margin.

The Senate budget resolution would slash $5.1 trillion in federal spending over the next decade, mirroring the resolution passed by the House 228 to 199 March 25, which cut spending by $5.5 trillion over the next nine years.

Both budgets agree on keeping sequestration cuts in place, and on repealing the Affordable Care Act.

House Votes to Repeal Sustainable Growth Rate; Senate Delays Action

The House voted 392-37 to approve legislation that would eliminate the Sustainable Growth Rate, a method currently used by the Centers for Medicare and Medicaid Services to control spending by Medicare on physician services.

While the House voted on March 26, the Senate adjourned for spring recess without acting on the bill.

Physicians are now faced with the prospect of a 21 percent cut in Medicare reimbursement when the current SGR payment patch expires next week on March 31.

Report: 2 in 5 Cancer Patients “Seriously Concerned” About Bankruptcy

Out-of-pocket costs for health care remain a top concern for many people living with cancer, according to a report by the Cancer Support Community, an international nonprofit.

The study, “An Insight into Patient Access to Care in Cancer,” surveyed 511 cancer patients, 480 of whom live in the U.S. Nearly 90 percent of the respondents were women, and nearly two-thirds were between the ages of 45 and 64.

Pitt, Carnegie Mellon and UPMC Form Big Data Alliance

Three Pittsburgh institutions—Carnegie Mellon University, the University of Pittsburgh, and the University of Pittsburgh Medical Center—are pooling their electronic medical records to form the Pittsburgh Health Data Alliance.

The alliance is funded by UPMC and designed to support applied research and commercialization, along with basic foundational research in medicine and computer science. UPMC Enterprises, the commercialization arm of UPMC, will lead the effort.

In Brief

  • FDA’s Richard Pazdur named one of 50 World’s Greatest Leaders by Fortune magazine

  • Elizabeth Jaffee receives clinical care research award from AACR

  • Jimmie Holland receives Women of Influence award

  • Gairdner Foundation names 2015 award winners

  • Bloomberg Philanthropies to launch Data for Health system

Drugs and Targets

  • CHMP grants positive opinion to Gardasil 9 HPV vaccine

  • EMA grants orphan designation to Reolysin

  • Teikoku Pharma USA submits NDA for alcohol-free docetaxel formulation

  • Rich Pharmaceuticals plans to launch clinical trials at Khon Kaen University in Thailand

20150327 - Mar. 27, 2015