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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
        ISSUE 8 – FEB. 26, 2016PDF



        Slamming the Door

        Part V: Gilman’s Resignation

        Gilman’s letter of resignation, dated May 8, 2012, concludes with a hard slam:

        “The purpose of this letter is to indicate my intention to resign from CPRIT, effective (with your permission) on October 12, 2012. At that time I will have worked for CPRIT for over three years—I believe longer than originally anticipated.

        “During that time we have launched strong programs because funding decisions have been based on high-level competitions, where the judges have been some of the best cancer researchers and physicians in the country—free of conflicts of interest and all coming from outside of Texas.

        “It was exciting to launch this program, to design effective requests for applications, and to oversee the peer review process.



        Capitol Hill Briefing Focuses on Moonshot’s Provision to Integrate FDA Cancer Portfolio

        When the White House proposed a $1 billion startup fund for the National Cancer Moonshot, a largely unexpected directive to reform FDA raised many questions among oncology insiders.

        The agency will create a virtual Oncology Center of Excellence, the administration proposals and budget documents state.

        Alas, nobody can claim to understand what “virtual” means in this context, and how the $75 million in proposed fiscal 2017 mandatory funds would be used to “leverage the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, and devices.”

        In Brief

        • Laurie Glimcher named president and CEO at Dana-Farber

        • Robert Califf confirmed as FDA Commissioner

        • Mandi Pratt-Chapman named associate center director at GW Cancer Center
        • Steve Limentani named VP and chief research officer at Mission Health

        • Robert Korngold receives lifetime achievement award from the American Society for Blood and Marrow Transplantation

        • Breast Cancer Research Foundation expands research program with Pfizer portfolio

        • Bharat Aggarwal has seven papers retracted from Biochemical Pharmacology 

        • Commission on Cancer honors 27 programs for outstanding achievement

        • Kids V Cancer named one of top 10 most innovative companies

        • Indiana University Simon Cancer Center receives grant from Kay Yow Cancer Fund
        Drugs and Targets

        • FDA approves Gazyva for follicular lymphoma

        • FDA approves Afinitor for GI or lung neuroendocrine tumors

        • FDA grants Breakthrough Designation to PKC412 (midostaurin)

        20160226 - Feb. 26, 2016
        ISSUE 7 – FEB. 19, 2016PDF



        Should ODAC Vote? Yes? No? Undecided?

        At its most recent meeting, in July 2015, the FDA Oncologic Drugs Advisory Committee voted…

        No, it didn’t vote!

        Breaking with a long-standing tradition, the agency asked ODAC members to “discuss” the key questions of risk vs. benefit of an experimental therapy instead of reducing their answers to a yea-or-nay vote. Agency officials are mum on the subject of whether not voting has become a thing.

        News Analysis

        Rejected Therapy Reveals Inconsistency of FDA Procedures for Drugs, Immunotherapies

        Reform of the FDA oncology program is emerging as the immediately tangible element of the Obama administration’s moonshot program.With a modest $75 million commitment, the administration may be able to standardize the manner in which elements of modern cancer care are reviewed and approved by the regulatory agency (The Cancer Letter, Feb. 12).

        As it stands, immunological and cellular cancer therapies as well as diagnostics don’t go through the same review procedures as cancer drugs and biologics.

        Slamming the Door

        Part IV: Nobel Laureate in Crosshairs

        In early 2012, Gilman was under the impression that CPRIT was functioning smoothly.

        Then, to his surprise, the first of a series of controversies surfaced.

        CPRIT’s peer reviewers had evaluated 40 applications for Multi-Investigator Research Applications, the largest CPRIT grants designed to fund team science, recommending that seven of these project receive funding. This was no small undertaking. The applications described multiple projects and core facilities.

        Report: Medicare Pays 340B Hospitals Less Part B Drug Reimbursement

        A group advocating for the 340B Drug Discount Program examined the widely held belief that health care organizations enrolled in the controversial federal program receive significantly higher reimbursement for drugs than institutions that do not take part in the program.Previously, a July 2015 study by the Government Accountability Office found that, per beneficiary, Medicare Part B drug spending was indeed higher at 340B hospitals than at non-340B hospitals.

        In Brief

        • Arnold Foundation gives $7.2 million to drug pricing programs
        • Joan Schiller named deputy director at Inova Cancer Institute
        • Jeannie Lee receives 2016 Lurie Prize
        • Canadian Cancer Society names four excellence award winnerse
        • Marcia McNutt named president of National Academy of Sciences
        • Medical Oncology & Hematology Associates of Northern Virginia joins Inova Medical Group

         

        20160219 - Feb. 19, 2016