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October 2015PDF

 

 Drugs and Targets

FDA Approves Imlygic as First Oncolytic Viral Therapy in the U.S., for Melanoma

FDA approved Imlygic (talimogene laherparepvec) as the first oncolytic viral therapy in the U.S.

Imlygic, developed by Amgen, is indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic has not been shown to improve overall survival or have an effect on visceral metastases.

Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce granulocyte-macrophage colony-stimulating factor, an immunostimulatory protein. Imlygic causes cell lysis rupturing tumors and releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown, according to Amgen.

Also:

 Breast Cancer

Phase III Trial Finds Equivalent OS Rates Between APBI Brachytherapy and Whole Breast Irradiation Therapy

A prospective, randomized, multicenter phase III study comparing accelerated partial breast irradiation with interstitial multicatheter brachytherapy to whole breast irradiation showed that APBI brachytherapy lead to equivalent overall survival and local and regional cancer control rates, as compared to WBI after breast conserving surgery for selected patients with early stage breast cancers.

The primary objective of the trial was to assess the role of APBI brachytherapy alone compared to whole breast irradiation with boost in a defined group of patients with invasive (stage I-IIA) breast cancer or ductal carcinoma in situ (stage 0) who underwent breast-conserving surgery.

 Non-Small Cell Lung Cancer

Patients Receiving IMRT Had Less Toxicity Compared to 3D CRT, Study Finds

Patients with locally advanced non-small cell lung cancer that received intensity modulated radiation therapy had less severe lung toxicity and were able to better tolerate their chemotherapy compared to patients who received 3D conformal radiation therapy, according to a secondary analysis of a large phase III trial.

The study, NRG/RTOG 0617, originally enrolled patients from 2007 to 2011, and compared a high dose of 74 Gy to the standard dose of 60 Gy. All underwent concurrent chemotherapy (carboplatin/paclitaxel, with or without cetuximab) and either 3D CRT or IMRT. In the study, 482 patients were treated with radiation—53 percent with IMRT and 47 percent with 3-D CRT.

Prostate Cancer

Phase III Trial Demonstrates Shorter, Hypofractionated RT Can Deliver Similar Results Compared to Conventional RT

 Mesothelioma

WT1 Vaccine Doubles PFS In MPM Patients in Phase II Trial

 Renal Cell Carcinoma

Study: Lenvatinib-Everolimus Combination Can Improve PFS

 Carcinoid Syndrome

Telotristat Etiprate Demonstrates Clinical Benefit in Phase III Study

 Cervical Cancer

Outreach Program Boosts HPV Vaccine Three-Dose Series Completion

 NCI CTEP-Approved Trials For the Month of October
20151103 - Nov. 3, 2015
ISSUE 40 – OCT. 30, 2015PDF

How Much is a Drug Worth?

A Provocative Model Puts a Price on Benefit

 

Eli Lilly & Co. didn’t ask Dan Goldstein, an oncologist at the Winship Cancer Institute at Emory University, to price their drugs, but he volunteered his services anyway.

Indeed, Lilly Oncology is unlikely in the extreme to concur with the price he proposed for necitumumab, a front-line treatment for locally advanced or metastatic squamous non-small cell lung cancer.

Necitumumab, which at this writing is awaiting FDA approval, would be used in combination with a doublet treatment of gemcitabine and cisplatin. This Biologics License Application is all the more important because the treatment of squamous NSCLC hasn’t changed in over 15 years.
 

Conversation with The Cancer Letter

Lilly’s PACE Continuous Innovation Indicators

Visualize Progress and Value in Research

Lilly Oncology has launched a novel value assessment tool that aggregates 40 years of oncology data to measure progress and identify unmet needs in cancer treatments.

The tool, called PACE Continuous Innovation Indicators, or PACE CII, is an effort to visualize progress in cancer treatments with the flexibility to accommodate different cancer subtypes.

PACE CII, launched earlier this year, contains data on 12 solid tumors: namely cancers of the breast, colon, rectum, liver, pancreas, and prostate, as well as melanoma, non-small cell lung cancer, gastric cancer, renal cancer, testicular cancer and endometrial cancer.

    Capitol Hill

    Budget Deal Eases Sequestration,

    Includes Medicare Site Neutrality

    Congress passed a two-year budget deal that would raise government spending as well as the debt ceiling.

    The bill includes an $80 billion total budget increase, divided evenly between non-military and military programs, and raises the previous caps set by sequestration. The bill also suspends the debt limit until March 2017.

      A Third of Hospitals Will Drop Out of 340B if HRSA Enacts New Guidance, Survey Finds

      Hospitals serving large populations of low-income patients stand to lose up to seven figures a year in drug discounts if proposed regulatory changes to the 340B program are enacted, the program’s supporters say.

      The Health Resources and Services Administration issued a sweeping guidance that would provide stricter definitions for which patients and entities should be covered.

        In Brief

        • Kathy Helzlsouer named chief medical officer and associate director of NCI DCCPS

        • Thomas Graves and Jeanny Aragon-Ching join Inova cancer institute

        • Friends of Cancer Research honors Marlene Malek, Reps. Diana DeGette and Fred Upton

        • MD Anderson Cancer Center expands Moon Shots Program

        • CureSearch for Children’s Cancer awards $260,000 in grants

        Drugs and Targets

        • Amgen’s Imlygic approved as first U.S. oncolytic viral cancer therapy

        • Imbruvica wins 2015 Prix Galien Award

        • FDA grants priority review to MCNA in certain bladder cancer patients

        20151030 - Oct. 30, 2015
        ISSUE 39 – OCT. 23, 2015PDF

        Pazdur: “The Primary Endpoint of Any Trial Should be the Patient.”

         

        RICHARD PAZDUR and ELLEN GOODMAN were honored by the National Coalition for Cancer Survivorship for their contributions to cancer care at the “Focus on the Care” reception Oct. 21 in Washington, D.C.

        Pazdur is the director of the FDA Office of Hematology and Oncology Products, and Goodman is a Pulitzer Prize-winning columnist, author and the founder of The Conversation Project, a national public health campaign focused on end-of-life care.

        Goodman received the inaugural Jessie Gruman Award for Patient Engagement, established with a grant from the Center for Advancing Health.

         

        ACS Recommends First Mammogram at 45, Transitioning to Biennial Screening After 55

        The American Cancer Society published a breast cancer screening guideline that seems to steer toward the middle course in deciding when mammography screening should start and how often it should be performed.

        • The ACS guideline now says 45 is a good age to get the first mammogram. In the past, the society recommended starting at 40. The U.S. Preventative Services Task Force gives a “C” rating to screening before age 50.

        • Repeating mammograms every other year after age 55 is acceptable, the society now states. In the past, the society recommended annual mammography screening. USPSTF said screening should be biennial after age 50.

        Conversation with The Cancer Letter Wender: ACS Guideline Hinges on Shared Decision Making

        The Cancer Letter invited Richard Wender, chief cancer control officer of the American Cancer Society, to describe the rationale for the society’s new guideline for breast cancer screening.

        Guest Editorial Brawley on Mammography: What we Know, What we Don’t Know, and What we Believe

        By Otis W. Brawley

        I have watched the rhetoric and heated debate about screening at age 40, now 45, and 50 for 25 years and am miffed that the discussion consistently ignores the obvious things we can do to save lives.

        National Academy of Medicine Elects 80 Members

        The National Academy of Medicine elected 80 members during its annual meeting, including at least 17 whose work focuses on cancer treatment and research.

        “Our newly elected members represent the brightest, most influential, and passionate people in health, science, and medicine in our nation and internationally,” said Victor Dzau, president of the academy, formerly known as the Institute of Medicine.

        Vice President Biden Calls For A National Commitment to Cancer Research Funding

        Vice President Joe Biden, in a Rose Garden address announcing his decision to not run for president, called for a national commitment to end cancer—expressing that, were he to run and be elected, it would be a goal of his presidency.

        “If I could be anything, I would have wanted to have been the president that ended cancer, because it’s possible,” Biden said Oct. 21. He said that his window of opportunity to mount a winning campaign had closed. “While I will not be a candidate, I will not be silent,” he said.

        In Brief

        • Pazdur and Goodman honored by NCCS
        • ACCC announces six winners of 2015 Innovator Awards
        • Jodi Daniel joins Crowell & Moring LLP
        • Kids v Cancer awarded Drucker Prize for Nonprofit Innovation
        • ACCC publishes white paper on integrated health care systems
        Drugs and Targets

        • FDA approves Onivyde in metastatic pancreatic adenocarcinoma
        • Yondelis approved for liposarcoma and leiomyosarcoma
        • FDA grants de novo clearance to Sonablate 450 for prostate tissue

        CORRECTION: A previous version of last week’s In Brief was unclear in its headline referring to Beth Israel Deaconess cancer center. It has been corrected to say that Manuel Hidalgo was named director of the Leon V. & Marilyn L. Rosenberg Clinical Cancer Center and chief of the Division of Hematology-Oncology at Beth Israel Deaconess Medical Center. Hidalgo will oversee all clinical cancer programs, reporting to Pier Paolo Pandolfi, director of the BIDMC Cancer Center and its Cancer Research Institute.
        20151023 - Oct. 23, 2015