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BREAKING NEWS – MARCH 8, 2016 

In an Experiment, CMS Will Vary Part B Drug Payments by Providers’ ZIP Codes

Is Average Sales Price plus 6 percent the right amount to pay doctors under the Medicare Part B program?

Would a smaller margin diminish what may be an incentive to prescribe the most expensive drugs on the market? With clinical performance being equal, or close enough to equal, is it not better for the doctor’s wallet to bill 6 percent of the highest possible ASP available?

In a move that immediately set off an explosion in the cancer field, the Centers for Medicare and Medicaid Services is on the verge of announcing a Part B Drug Payment Demo, a project where ASP add-ons would vary based on zip codes.

    20160308 - Mar. 8, 2016
    ISSUE 9 – MARCH 4, 2016PDF



    NCI Developing Mouse Models To Succeed NCI-60 Cell Lines

    The NCI-60, a panel of 60 cancer cell lines that have become the Rosetta Stone for the development of anticancer drugs, may be entering its twilight years as NCI develops new, and more expansive, patient-derived xenografts, or PDX models.

    For over 25 years, the NCI-60, a set of about a dozen tissue types—leukemia, non-small cell lung, small cell lung, colon, CNS, melanoma, ovarian, renal, and breast—have been used to perform initial screens on over 100,000 compounds.

     

    Conversation with The Cancer Letter

    Doroshow: Evidence Suggests PDX Models Come Closer to Simulating Human Cancer

    NCI is developing patient-derived xenograft mouse models as a potential substitute for the NCI-60 cell lines, a standard screen which experts say can no longer keep up with advances in cancer research and targeted molecular therapy.

    “The goal is to try to understand whether these new models will be more successful in providing a better reflection of the underlying biology in the context of the clinical history and treatment history of patients from whence the tissues came,” said James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis and deputy director for clinical and translational research.

    Slamming the Door

    Part VI: The Provost’s Choice

    After my conversation with Gilman, I called MD Anderson and asked to talk with somebody about the $18 million grant for a biotech incubator.

    First, folks at the press shop told me that they view the controversy arising from the application as CPRIT’s problem.

    Let’s see: the wife of president of MD Anderson gets a grant seemingly out of turn, causing a political disaster, and this is not an MD Anderson problem?

    National Academy of Medicine Publishes Report on Categorizing Different Ovarian Cancers

    Ovarian cancer should not be categorized as a single disease, but as many different cancers involving the ovary, according to a report published by the National Academy of Medicine.

    Questions remain on how and where various ovarian cancers arise, said the report that also presents research opportunities for reducing the number of women who are diagnosed with or die from ovarian cancers. Roughly two-thirds of women are diagnosed at an advanced stage when the cancer has already spread beyond the ovary, of which less than 30 percent survive past five years. The report was also sponsored by the Centers for Disease Control and Prevention.

    Funding Opportunity

    FDA Providing $2 Million for Natural History Studies in Rare Diseases

    FDA will provide $2 million in two to five research grants for the study of the natural history of rare diseases. The objective of the grants is to expedite the development of products for these conditions.

    The Feb. 29 announcement marks the first time FDA will provide funding through its Orphan Products Grants to collect data on the progression of specific rare diseases in individuals over time.

    In Brief

    • Joan Massagué wins Pezcoller-AACR International Cancer Research Award

    • David Weiner named executive vice president at The Wistar Institute

    • Douglas Levine named director of gynecologic oncology at NYU Perlmutter Cancer Center
    • Lauren Streicher joins Northwestern Medical Group as medical director

    • Michael Bukosky appointed chief operating officer of USMD Holdings Inc.

    • International Cancer Genome Consortium authorizes 1,000th user

    • IBM and New York Genome Center to collaborate using Watson technology

    • Vantage Oncology LLC acquired by McKesson Specialty Health

     Drugs and Targets

    • Imbruvica granted approval for first-line CLL patients

    • Health Canada approves Opdivo for metastatic NSCLC

    • FDA grants orphan drug designation to SELLAS’s WT1 cancer vaccine

    • EMA grants orphan drug designation to venetoclax

    • FDA and EMA grant orphan designations to FLAG-003 for glioma

    • Merck KGaA, Pfizer and Verastem enter into avelumab research agreement

    • NanoString Technologies and Merck to collaborate on Keytruda assay

     

    20160304 - Mar. 4, 2016
    February 2016PDF

     

    Leukemia

    Phase III Blincyto Study Stopped Early After Meeting OS Primary Endpoint

    A phase III study of Blincyto met its primary endpoint of overall survival in patients with acute lymphoblastic leukemia following a prespecified interim analysis. The study was stopped early.

    The randomized, open-label TOWER study evaluated the efficacy of Blincyto (blinatumomab) versus the standard of care in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

    Patients were randomized in a 2:1 ratio to receive Blincyto or treatment with investigator choice of one of four protocol defined SOC chemotherapy regimens.

       

      Soft Tissue Sarcoma

      Halaven Study Improves Overall Survival In Liposarcomas and Leiomyosarcomas

      Full results from a phase III study showed improved median overall survival in unresectable locally advanced liposarcomas and leiomyosarcomas in patients receiving Halaven (eribulin), compared to dacarbazine.

      The clinical trial, study 309, included data from 452 adults, and was published in The Lancet, which also published an editorial discussing the study results.

      The study compared patients treated with eribulin mesilate (1.4 mg/msquared intravenously on days 1 and 8) and those treated with dacarbazine (850 mg/msquared, 1000 mg/msquared, or 1200 mg/msquared [dose dependent on center and clinician] intravenously on day 1). Additional endpoints included progression-free survival and quality of life.

         

        Breast Cancer

        OBI-822/821 Phase II/III Study Does Not Meet PFS Endpoint, But Shows Positive Results In Patients with Immune Response

        OBI Pharma Inc., announced topline results from a phase II/III study of OBI-822/821 (formerly OPT822/OPT821), which evaluated the clinical benefit and immunogenicity in patients with metastatic breast cancer. The study did not meet the primary efficacy endpoint of progression-free survival.

        However, patients who demonstrated an immune response showed highly significant improvement in progression-free survival and the secondary endpoint of overall survival is trending towards statistical significance. OBI-822/821 was generally well tolerated with no major safety concerns. Full results will be presented at an upcoming international scientific conference.

           

          Pancreatic Cancer

          Two Studies Evaluate 2nd Line Treatments Following Abraxane

           

          Non-Small Cell Lung Cancer

          Gilotrif Improves PFS Compared to Iressa in Phase IIb Trial

           

          Thyroid Cancer

          Study: Afirma Genomic Test Can Reduce Unnecessary Fine Needle Aspiration Biopsies

           

          NCI CTEP-Approved Trials for the Month of February

           

          Drugs and Targets

          • Gazyva Combination Approved In Follicular Lymphoma
          • FDA approves Afinitor for GI and lung NETs
          • Venetoclax receives third FDA Breakthrough Designation
          • FDA grants breakthrough designation to PKC412 (midostaurin)
          • FDA grants orphan drug designation to tazemetostat for malignant rhabdoid tumors
          • FDA grants orphan drug designation to CD101 IV for candidema
          20160229 - Feb. 29, 2016