20150605 - Jun 5, 2015
ISSUE 22 – JUNE 5, 2015PDF

NCI-MATCH to Bring in Public, Private Funds, Giving NCI New Urgent Scientific Agenda

ECOG-ACRIN Cancer Research Group is starting enrollment in NCI-MATCH, the most ambitious of NCI’s new generation of clinical trials.

In addition to being the centerpiece of the institute’s recently formed National Clinical Trials Network, NCI-MATCH—the name is an acronym for Molecular Analysis for Therapy Choice—provides a strong case for garnering Congressional support for the White House precision medicine initiative.

The $215 million program proposed by Obama as part of appropriations for fiscal 2016 hasn’t translated into congressional appropriations. The PMI budget request includes $70 million for NCI to scale up efforts to identify genomic drivers in cancer and apply that knowledge to develop more effective approaches to cancer treatment. Similarly, the new-generation trials would boost the NCI case in pursuit of a share of another potential windfall: the 21st Century Cures.

See also:

Conversation with The Cancer Letter

Doroshow: NCI-MATCH is an Example of What Smart Public-Private Partnerships Can Do

The NCI-MATCH phase II study is intended to allow the institute and its clinical trials groups catapult to the premier role in cancer research.

In a conversation with The Cancer Letter, James Doroshow, director of the NCI Division of Cancer Treatment and Diagnosis, said NCI-MATCH established the institute as a trusted party in a complex, multi-agent trial intended to produce leads for government-funded investigators and pharma companies would be able to follow.

ASCO CEO Lichter to Step Down in June 2016

Allen Lichter, CEO of the American Society of Clinical Oncology and the Conquer Cancer Foundation of ASCO, announced June 1 that he would step down June 30, 2016.

Lichter has led ASCO since 2006.

Melanoma Drugs Could be Used to Treat Lung, Liver, Head-Neck and Colorectal Cancers

Three immunotherapy drugs approved for the treatment of melanoma may be used to treat advanced lung, liver, head and neck, and colorectal cancers, according to clinical trial results presented at the 2015 American Society of Clinical Oncology annual meeting in Chicago.

These drugs—Keytruda (pembrolizumab) by Merck, and Opdivo (nivolumab) and Yervoy (ipilimumab) by Bristol-Myers Squibb—are called checkpoint inhibitors because they release the molecular checkpoints that keep the immune system from attacking tumors.

    ESMO Scale Stratifies Magnitude of Benefit of Cancer Drugs

    The European Society for Medical Oncology May 30 published the ESMO Magnitude of Clinical Benefit Scale, a tool to assist oncology clinicians in evaluating the most effective anti-cancer medicines for their patients.

    According to the society, the ESMO-MCBS offers a “rational, structured and consistent approach to stratify a drug’s clinically meaningful benefit”—a scale that can be used in public policy decision-making, to develop or improve clinical guidelines, in day-to-day clinical situations.

      Canadian Judge Orders Tobacco Companies to Pay $12 Billion to About One Million Quebec Citizens

      A Quebec court ordered three major tobacco companies to pay US$12 billion, over 15 billion Canadian dollars, in damages in a landmark class action lawsuit.

      On June 1, Quebec Superior Court Judge Brian Riordan instructed Canadian tobacco companies JTI-Macdonald, Imperial Tobacco, and Rothmans, Benson & Hedges to pay punitive and moral damages to two groups of Quebecois plaintiffs. The lawsuit was filed in fall 1998, and legal proceedings began in 2012.

        ASCO President Peter Paul Yu’s 2015 Presidential Address

        A transcript of ASCO President Peter Paul Yu’s address at the 2015 ASCO Annual Meeting.

          Amgen Seeks to Depose Reporter, TCL Invokes First Amendment Shield

          Amgen Inc. is seeking to depose The Cancer Letter editor and publisher Paul Goldberg in connection with a shareholders suit stemming from his 2007 story about the results of a Danish trial of Aranesp.

          The Cancer Letter is contesting the subpoena, asserting first amendment protection and its rights to protect confidentiality of sources.

            Obituary

            Wally Sampson, 85, Challenged Alternative Remedies

            Wallace Ira Sampson, a longtime “quackbuster,” emeritus clinical professor of medicine at Stanford University, and former director of oncology at the Santa Clara Valley Medical Center, died May 25 following a three-month hospital stay for complications following cardiac surgery. He was 85.

            Sampson was one of a group of scientists and physicians who focused on the growing influence of alternative medicine, said Stephen Barrett, a fellow quackbuster.

              In Brief

              • Nicole Robinson named VP of Industry Relations at Fred Hutch

              • The Department of Defense appropriations bill includes an additional $12 million for lung cancer research

              • The Community Oncology Alliance announces nine practices received oncology medical home designation

              20150529 - May 29, 2015
              ISSUE 21 – MAY 29, 2015PDF

              Neupogen’s New Indication:

              Nuke Mishaps and Terrorism

              Neupogen, a drug widely used in oncology, recently received an FDA approval for boosting survival in people acutely exposed to myelosuppressive doses of radiation, also known as hematopoietic syndrome or acute radiation syndrome.

              Neupogen (filgrastim)—a myeloid growth factor, a class of drugs that includes GM-CSF and Neulasta—as well as other similar drugs have been used to treat victims of radiation and nuclear accidents since Chernobyl.

              “Based on my experience treating victims of many nuclear and radiation accidents worldwide, I think drugs like G- and GM-CSF may be useful in accelerating bone marrow recovery in persons exposed to moderate doses of ionizing radiations in whom sufficient numbers of undamaged bone marrow cells remain to respond and who have no irreversible damage to other tissues and organs such as the skin and lungs,” said Robert Peter Gale, an American physician who was the first physician to use these drugs in the aftermath of a nuclear accident.

              Two Chernobyl Doctors were the First Humans to Get GM-CSF

              By Robert Peter Gale

              By 1986, there were substantial data in animals that molecularly-clone human haematopoietic growth factors, such as granulocyte-macrophage colony stimulating factor (GM-CSF), could accelerate bone marrow recovery and increase survival after exposure to high-dose ionizing radiations given under controlled experimental conditions.

              On April 26, 1986, my Soviet colleagues and I were suddenly faced with treating about 200 firefighters, emergency personnel and technicians exposed to very high doses of ionizing radiations from an accident at the Chernobyl nuclear power facility in Ukraine. The most severely affected persons receiving >2 Gray (Gy; for reference the average dose of the A-bomb survivors was 10 times less and there were no survivors of doses >1 Gy) were flown to Moscow where we set up operations at Clinical Hospital 6, a high security facility attached to the Institute of Biophysics.

              FBI Probes Who Knew What and When in Power Morcellation Imbroglio

              The Federal Bureau of Investigation is reportedly trying to establish whether Johnson & Johnson—one of the largest manufacturers of power morcellators—knew as early as nine years ago that the gynecological device can disseminate uterine cancers.

              According to the Wall Street Journal, the FBI’s Newark, N.J. office interviewed three people, including Robert Lamparter, a retired pathologist who alerted Ethicon, a J&J subsidiary, about potential problems with morcellators in 2006.

              Federal Appeals Court Instructs Tobacco Companies to Issue “Corrective Statements”

              The U.S. Court of Appeals for the D.C. Circuit Court upheld on May 22 a lower court’s order requiring nine tobacco companies to publish “corrective statements” about the dangers of tobacco and its practices of marketing to children.

              The ruling stems from a case the federal government brought against a group of the largest tobacco companies in 1999 under anti-racketeering law.

                ASCO Conquer Cancer Foundation Names 2015 Winners of Young Investigator, Career Development, and Clinical Research Awards

                The Conquer Cancer Foundation of the American Society of Clinical Oncology announced the recipients of the 2015 Young Investigator Awards, Career Development Awards, Advanced Clinical Research Award in Breast Cancer, and the Comparative Effectiveness Research Professorship in Breast Cancer.

                The recipients will be recognized during the 2015 ASCO Annual Meeting taking place May 29 – June 2 in Chicago.

                  In Brief

                  • Shohreh Shahabi named chief of gynecologic oncology at Northwestern University

                  • Varian Medical Systems and Flatiron Health to collaborate on EMR software

                  • AbbVie completes its acquisition of Pharmacyclics Inc.

                  Drugs and Targets

                  • EU Approves Aloxi for CINV in pediatric patients

                  • CHMP issues positive opinion for change in Imbruvica label

                  • Halozyme Therapeutics and Ventana Medical Systems to collaborate on PEGPH20 assay

                  20150522 - May 22, 2015
                  ISSUE 20 – MAY 22, 2015PDF

                  The Price of Deception: How a Duke Patient was Harmed In Potti’s Fraudulent Trials

                  Joyce Shoffner would never have predicted that Duke University, an institution she revered and at one time worked for, would put her in a breast cancer clinical trial testing a fraudulent technology.

                  “They advertised publicly that this science offered an 80 percent cure rate,” Shoffner said. “To have the type of cancer I had, I was just going to do that, there was nobody that was going to stop me, because this was what I was told and this was what I believed was going to happen.”

                  In July 2008, Shoffner became patient No. 1 in the trial that promised to choose the best therapy for the unique characteristics of her disease. Alas, the groundbreaking genomic predictors pioneered by Anil Potti and his mentor Joseph Nevins, which the trials were testing, would turn out to be fraudulent.

                  FDA Notifies 300 Medical Practices that they May Have Purchased Unapproved Prescription Drugs

                  FDA notified more than 300 medical practices that they may have purchased unapproved prescription drugs or injectable devices from a foreign supplier, Gallant Pharmaceutical International.

                  “Gallant and twelve individuals, including a doctor and an office manager, have been convicted for their roles in distributing drugs and devices that have not been approved or cleared by FDA in the U.S.,” the agency’s letter to the practices said. “The unapproved drugs and unapproved/uncleared devices sold by Gallant were obtained from foreign sources and shipped and stored outside of the regulated supply chain.”

                  The drugs sold include Avastin, Erbitux, Herceptin, Rituxan, and Velcade.

                  Four Cancer Charities Charged with Fraud in Raising $187 Million

                  The Federal Trade Commission charged four cancer charities with fraudulently raising $187 million between 2008 and 2012.

                  The federal complaint names Cancer Fund of America Inc., Cancer Support Services Inc., their president, James Reynolds, Sr., and their chief financial officer and CSS’s former president, Kyle Effler; Children’s Cancer Fund of America Inc. and its president and executive director, Rose Perkins; and The Breast Cancer Society Inc. and its executive director and former president, James Reynolds II.

                  CPRIT Awards 41 Grants, Totaling Over $89 Million

                  The Cancer Prevention and Research Institute of Texas awarded 28 grants through its academic research program, 11 grants through its prevention program and two grants through its product development research program.

                  Totaling over $89 million, the grants include nearly $31 million for six Core Facilities Support Awards. Additional research grants help support the recruitment of cancer scientists to academic institutions in Texas.

                    In Brief

                    • PCORI Approves $120 million in research grants

                    • Catherine Brown named president of John Wayne Cancer Foundation

                    • Community Oncology Alliance and Community Oncology Pharmacy Association appoints advisory board

                    • Meridian Health and Hackensack University Health Network sign definitive merger agreement
                    Drugs and Targets

                    • FDA grants fast track designation to AG-120

                    • Palmetto GBA issues draft LCD for Oncotype DX prostate cancer test

                    • Baylor Research Institute and TGen extend collaboration