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March 2015PDF


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
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
ISSUE 11 – MARCH 20, 2015PDF

“Trust Has Been Broken” at MD Anderson; UT Chancellor Calls for Shared Governance

There will be no more faculty surveys at MD Anderson, UT System Chancellor William McRaven pledged to the institution’s faculty in a closed-door meeting March 18.

“I don’t intend to have any more surveys,” McRaven said in a meeting where he acknowledged the concerns of the faculty, but also expressed support for the administration of the Houston-based cancer hospital.

“I think your surveys—at least the ones I’ve seen—give me a clear indication of where the faculty is,” McRaven said at the meeting that lasted for about an hour-and-a-half. “And maybe it’s not unanimous, but I’ve got to tell you that the numbers in the surveys are pretty damning, for the lack of a better term.”

McRaven, the former admiral who, as head of the U.S. Special Operations Command, oversaw the covert operation responsible for killing Osama bin Laden, expressed support for the institution’s Faculty Senate, thereby establishing it as the negotiating partner for the administration headed by President Ronald DePinho.

MD Anderson Pre-empts AAUP Report by Releasing Draft to The Press—with a Foreword

MD Anderson’s message to the American Association of University Professors boils down to this: A pox on your house.

For starters, President Ronald DePinho and his administration declined to meet with an AAUP committee when it came to campus to investigate a tenure dispute. (The Cancer Letter, Sept. 19, 2014).

This snub notwithstanding, AAUP provided MD Anderson with a draft report marked CONFIDENTIAL: NOT FOR RELEASE. The association’s objective was to give MD Anderson the opportunity to comment—and a comment is exactly what they got.

In the afternoon of March 13, the cancer center’s executive team threw the thing to the press.

Varmus Recommends Funding Boost For NCI Cancer Centers Program

NCI Director Harold Varmus announced plans to gradually increase in the institute’s cancer centers budget over the next four to five years.

“It seems to me, we get more bang for our buck from the centers—many of which have many direct-cost budgets of no more than a million dollars, a lot less than the grants we give out,” Varmus said at the March 11 meeting of the NCI Board of Scientific Advisors.

He suggested boosting the centers budget by $10-15 million per year, increasing the total cancer centers budget from $260 million to about $310 million. This plan follows a proposal to reconfigure the formula for awarding cancer center grants.

Lowy Discusses Reducing Cuts to Modular R01 Grants

Following Harold Varmus’s remarks to the Board of Scientific Advisors, Douglas Lowy, soon-to-be acting director of the NCI, focused on reducing the amount of the planned cuts for modular R01 grants.

The plan is cut the reductions in half starting in this fiscal year, from the automatic 17 percent reduction to 8.5 percent, or cutting a 10 percent reduction to 5 percent.

“Our long-term goal is to try to eliminate those cuts completely, but this we estimate will cost about $10 million from the RPG pool, and we would like to see what the is impact on that,” Lowy said.

ASCO Announces Winners Of 2015 Special Awards

The American Society of Clinical Oncology announced the winners of its Special Awards Program. 

The Special Awards recognize the dedication and significant contributions of researchers, patient advocates, and leaders of the global oncology community to enhancing cancer prevention, treatment, and patient care. 

ASCO also named seven recipients of the Fellows of the American Society of Clinical Oncology distinction.

In Brief

  • Fadlo Khuri named president of the American University of Beirut

  • Philip Low receives the AACR Award for Outstanding Achievement in Chemistry in Cancer Research 

  • Julie Johnson receives Distinguished Scientist Award from Southeastern Universities Research Association

  • Thomas Merchant named chair of St. Jude Department of Radiation Oncology

  • The Community Oncology Alliance forms Community Oncology Pharmacy Association

Drugs and Targets

  • EU approves Jakavi in Polycythemia Vera

  • EMA grants orphan designation to ImMucin

  • Hong Kong Department of Health approves Abraxane

20150320 - Mar. 20, 2015