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ISSUE 19 – May 13, 2016PDF

art 42-19 showdown

CMS Drug Payment Experiment Heads Toward Showdown on Capitol Hill

A demonstration project in which the Centers for Medicare& Medicaid Services hopes to investigate the impact of reimbursement based on Average Sales Prices of drugs is running into strong opposition, as a large number of cancer groups submitted public comments urging the agency to abandon the endeavor.

The agency’s stated goal for tweaking the ASP-based reimbursement formula is to learn whether it gives physicians the incentive to prescribe the most expensive treatments available.

Opponents—including oncology professional groups and pharmaceutical companies—say that experimentation with ASP-based reimbursement, which is currently set at ASP plus 4.3 percent, will make it economically unfeasible for oncology practices to treat Medicare patients.

Agus: $200 Million Interdisciplinary Institute to Focus on Data Modeling

A few years ago, at dinner with technology entrepreneur Larry Ellison, David Agus, director of the University of Southern California Center for Applied Molecular Medicine, mentioned his dream of opening an interdisciplinary cancer center.

“I said, it really would be an amazing thing if we could start to get people in one place and have residences, so the greatest physicists, mathematicians, engineers can actually come in and live there and be engrossed in cancer,” said Agus, professor at the Keck School of Medicine of USC and USC Viterbi School of Engineering.

““Well, how much would it be to kind of put together such a building and program?” Ellison, Oracle Corporation’s chairman of the board and chief technology officer, said to Agus at the time.

“You know, about $200 million,” Agus said.

“Done,” Ellison responded.

Slamming the Door

Part XII: Scientists Vote with Their Feet

In their op-ed piece, Gilman and Sharp stated what it would take to fix CPRIT’s problems. That was the polite version of the Gilman Plan.

The spoken version was more blunt: get rid of the “assholes” on the oversight board, jettison the administrators, then—maybe—CPRIT’s credibility would be restored.

NIH Makes Sweeping Changes in Clinical Center Governance

The NIH Clinical Center will be placed under a new system of governance, similar to that of hospitals.

Replacing Director John Gallin and the current management structure, NIH has begun “the process of changing the leadership structure of the Clinical Center to model those of world class hospitals in the United States,” institute officials said in a statement.

ACS Report Assesses Progress in 25-Year Goal Against Mortality

The American Cancer Society published a report assessing the progress made in its 25-year goal to reduce cancer death rates by 50 percent. The report finds areas where progress was substantial, and others where it was not.

The report, appearing in the ACS journal CA: A Cancer Journal for Clinicians, said the best improvements were seen in cancers for which prevention, early detection, and treatment tools are available, including cancers of the lung, colon, breast, and prostate.

In Brief
  • Brigham Does Not Contest Plaintiffs’ Offers of Proof as Morcellation Cases Proceed
  • American Urological Association presents 2016 awards at annual meeting
  • Tom Andrus named chief digital officer at Prostate Cancer Foundation
  • Stand Up to Cancer and Boston College publish nursing training modules in immunotherapy
  • CancerCare publishes report on patient access and engagement
  • Cancer Support Community Benjamin Center presents awards
  • City of Hope receives $2.3 million R01 grant from NCI
  • BioDelivery Sciences International and Collegium Pharmaceutical form collaboration
  • Thomas Jefferson University joins TriNetX research network
  • UCLA and Leica Biosystems to collaborate in digital pathology
  • St. Jude raises $4 million in campaign Univision
  • PhRMA members invested $58.8 billion in R&D in 2015
Drugs and Targets
  • FDA expands Imbruvica label to include CLL and SLL
  • Health Canada approves Imbruvica in Waldenström’s macroglobulinemia
  • Health Canada grants conditional approval to Ibrance in breast cancer

 

20160513 - May. 13, 2016
ISSUE 18 – May 6, 2016PDF

art 42-18 fda on the moon final

Virtual is Not Enough

FDA’s Critics Call for Full Integration of Oncology Center Under Biden’s Moonshot

The White House moonshot to accelerate progress in cancer research directs FDA to consolidate its oncology portfolio.

However, oncology insiders say the manner in which the presidential initiative will be implemented could make the difference between political balderdash and genuine improvement in FDA regulation of cancer therapies.

The entire controversy boils down to the interpretation of one word: Virtual.

Moonshot Director Addresses AAADV Workshop

Greg Simon, executive director of the cancer moonshot task force, addressed the FDA-sponsored workshop for Accelerating Anticancer Agent Development and Validation in North Bethesda, Md., May 4.

He discussed the goals for the moonshot initiative, how the program could fit into the next presidential administration, and how to take the project international.

Slamming the Door

Part XI: Gilman’s Teachable Moment

During our first conversation in the spring of 2012, Gilman said that he would go public unless he received assurances that CPRIT would retain its integrity after his departure.

He wanted guarantees that the structure he built would not be turned into a political pigsty. With guarantees being hard to come by, it was obvious that he would end up slamming the door hard. Publicly.

FDA to Regulate All Tobacco Products, Including E-Cigs, In Historic Expansion

FDA issued final regulations for all tobacco products, including electronic cigarettes, cigars and hookah. The rules, with provisions aimed at restricting youth access and requiring premarket clearance for new products, will take effect Aug. 8.

The federal regulations include: not allowing tobacco products to be sold to persons under the age of 18, both in person and online; requiring age verification by photo ID; not allowing the selling of covered tobacco products in vending machines, unless in an adult-only facility; and not allowing the distribution of free samples.

National Academy of Sciences Elects 105 Members

The National Academy of Sciences elected 84 new members and 21 foreign associates from 14 countries in recognition of their distinguished and continuing achievements in original research.

Those elected today bring the total number of active members to 2,291 and the total number of foreign associates to 465. Foreign associates are nonvoting members of the academy.

Funding Opportunity

CureSearch Taking Applications
For Pediatric Research Awards

CureSearch for Children’s Cancer is taking applications for its International Grand Challenge Awards addressing three challenges in pediatric cancer treatment. The awards will be worth between $2 million and $3 million.

In Brief
  • American Cancer Society and CVS Health launch three-year antismoking campaign
  • Pershing Square Sohn Research Alliance funds seven young investigators

  • Sean Parker recognized by the Vatican for philanthropic work

  • Richard O’Reilly receives inaugural Society of Memorial Sloan Kettering Prize

  • David Weiner receives professorship and grant from W.W. Smith Charitable Trust

  • Canadian Cancer Clinical Trials Network launches national awareness campaign

Drugs and Targets
  • Eribulin receives EU approval in liposarcoma

  • Health Canada approves Lynparza in ovarian cancer

  • CHMP issues positive opinions for Imbruvica and Afinitor

  • AstraZeneca and Foundation Medicine to collaborate on diagnostic assays

  • AbbVie and CytomX Therapeutics to collaborate on probody drug conjugates

 

20160506 - May. 6, 2016
April 2016PDF

 

Head and Neck Cancers

Opdivo Extends OS in Phase III Squamous Cell Carcinoma Trial

A phase III trial of PD-1 inhibitor Opdivo showed significant survival benefit at one year—compared to investigator’s choice of methotrexate, docetaxel or cetuximab—in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101).

The one-year survival rate for Opdivo was 36 percent compared to 16.6 percent for investigator’s choice. The safety profile of Opdivo in CheckMate-141 was consistent with prior studies, with no new safety signals identified.

     

    Melanoma

    Opdivo-Yervoy Combination Demonstrates Two-Year Survival Rate of 69 Percent

    Overall survival data from CheckMate-069, a phase II trial of a Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma, demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma.

    CheckMate-069 evaluated 142 patients with previously untreated unresectable or metastatic melanoma who received either the Opdivo and Yervoy combination regimen (n=95) or Yervoy alone (n=47). The trial included patients with BRAF wild-type and BRAF V600 mutation-positive melanoma, and randomization was stratified by BRAF mutation status.

       

      Drugs and Targets

      FDA Grants Accelerated Approval To Venclexta Tablets in CLL

      FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

      The indication was approved based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

      Also:

         

        Ovarian Cancer

         

        Prostate Cancer

        Study: SBRT Delivers 98.6% Cure Rate at Five-Year Followup

         

        Soft Tissue Sarcoma

        Researchers: Radiation After Surgery Benefits Older Patients More than Younger Patients

         

        NCI CTEP-Approved Trials for the Month of April

         

        Letter to the Editor

        GOG Foundation Sends Rebuttal Letter to Oncolytics Biotech

        20160502 - May. 2, 2016