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ISSUE 2 – JAN. 15, 2016PDF



Obama Announces Moonshot to Cure Cancer

President Barack Obama announced a moonshot aimed at curing cancer, a project to be led by Vice President Joe Biden.

The United States can do “so much more,” Obama said in his seventh and final State of the Union address Jan. 12. “Last year, Vice President Biden said that with a new moonshot, America can cure cancer. Last month, he worked with this Congress to give scientists at the National Institutes of Health the strongest resources they’ve had over a decade.

“Tonight, I’m announcing a new national effort to get it done. And because he’s gone to the mat for all of us, on so many issues over the past 40 years, I’m putting Joe in charge of mission control. For the loved ones we’ve all lost, for the family we can still save—let’s make America the country that cures cancer once and for all.”

 When Moonshots Collide

Did Patrick Soon-Shiong attempt to scoop President Barack Obama’s State of the Union address?

Several days before Obama announced the federal government’s moonshot to cure cancer, Soon-Shiong put out a draft press release, claiming that the White House, NIH, FDA and pharmaceutical companies have united in “Cancer MoonShot 2020,” an immunotherapy clinical trials program he devised.

Soon-Shiong, founder and CEO of NantWorks and the Chan Soon-Shiong Institute of Molecular Medicine, ultimately announced his moonshot on Jan. 11, a day before Obama announced his.

 Conversation with The Cancer Letter

Soon-Shiong Says FDA & NCI are Onboard For His Moonshot; Feds Deny Involvement

Government agencies said the biotechnology billionaire Patrick Soon-Shiong had overstated the extent of their involvement in “Cancer MoonShot 2020,” the immunotherapy clinical trials program he put together.

In an in-depth conversation with Matthew Bin Han Ong, a reporter with The Cancer Letter, Soon-Shiong said that while his program doesn’t seek federal funds, it has the support of NCI and FDA officials.

Soon-Shiong said he and Vice President Joe Biden met to discuss their interlocking missions and are now pursuing them.

USPSTF Recommends Biennial Mammography Screening For Women Ages 50-74

The U.S. Preventive Services Task Force published its final recommendation statement on screening for breast cancer, delivering a B rating for mammography screening every two years in women between ages 50 and 74.

The task force also recommended selectively offering mammography to women below age 50, saying that the decision to begin that screening should be an individual one. The USPSTF gave this age group a C recommendation.

“Women who place a higher value on the potential benefit than the potential harms may choose to begin biennial screening between the ages of 40 and 49 years,” the task force wrote in its recommendations.

 Campaign for Tobacco-Free Kids Demands Recall of Gold Standard Accreditation of U.S. Chamber of Commerce

The Campaign for Tobacco-Free Kids said the U.S. Chamber of Commerce is undeserving of its Gold Standard accreditation by the CEO Roundtable on Cancer, saying it should be rescinded because of the trade group’s lobbying efforts against tobacco regulations.

In Brief

  • Leonard Zon receives Knudsen cancer genetics award from NCI
  • Amy McKee named acting deputy office director at FDA OHOP
  • Paul Kluetz appointed associate director of clinical science at FDA OHOP
  • Dean Tsarwhas named medical director at Northwestern Medicine Lake Forest Hospital
  • Rafat Abonour named medical liaison for the International Myeloma Foundation
  • Ravi Salgia joins City of Hope as chair of Department of Medical Oncology
  • FASEB publishes recommendations for research reproducibility
  • COA elects new board and executive committee members
Drugs and Targets

  • Blincyto receives conditional approval from Health Canada
  • FDA grants priority review to venetoclax in CLL
  • Sorrento Therapeutics and Karolinska Institutet form collaboration
  • Eisai submits MAA to European Medicines Agency for lenvatinib
  • MD Anderson and DelMar Pharmaceuticals form collaboration
  • Debiopharm International SA collaborates in EORTC trial
20160115 - Jan. 15, 2016
ISSUE 1 – JAN. 8, 2016PDF



Ellen Stovall, Pioneering Advocate For Survivorship, Dies at 69

Ellen Stovall, one of the most respected and knowledgeable cancer advocates in Washington, died Jan. 5.

The cause of death was a heart attack.

Stovall, 69, was first diagnosed with Hodgkin’s lymphoma in 1971. Her disease recurred in 1983. In 2007, she had bilateral mastectomies due to the late effects of the radiation treatment. Her heart disease and chronic pain were also attributed to her original treatment.

“Ellen is a rare transformational figure in cancer care, who saw an enormous unfilled need and led the development of the entire concept of cancer survivorship,” said Norman Coleman, head of the Experimental Therapeutics Section and associate director of the NCI Division of Cancer Treatment and Diagnosis, and senior medical advisor at the HHS Office of the Assistant Secretary for Preparedness and Response.

Nobel Laureate Alfred Gilman,
Defender of Good Science, Dies at 74

Alfred G. Gilman, a Nobel laureate who concluded his academic career in the role of chief scientific officer of the Cancer Prevention and Research Institute of Texas, died Dec. 23, 2015. Gilman, 74, had pancreatic cancer.

Gilman shared the 1994 Nobel Prize in Physiology or Medicine with Martin Rodbell of the National Institute of Environmental Health Sciences for their discovery of G proteins—guanine nucleotide-binding regulatory proteins. G proteins are central to signaling transduction, the process of receiving signals from outside the cell and activating a range of cellular responses.

G proteins are found in nearly all cells, and are central to body processes that include vision, smell, hormone secretion, and thinking in humans. Problems in G-protein signaling contribute to a range of diseases, including cholera, whooping cough, and cancer.

Cancer Death Rate Continues Steady Drop

Steady reductions in smoking combined with advances in cancer prevention, early detection, and treatment have resulted in a 23 percent drop in the cancer death rate since its peak in 1991, according to the annual Cancer Statistics report from the American Cancer Society.

The drop translates to more than 1.7 million cancer deaths averted through 2012. The findings were published in CA: A Cancer Journal for Clinicians. The report estimates there will be 1,685,210 new cancer cases and 595,690 cancer deaths in the United States in 2016.

Lab-Developed Tests

AMP Responds to FDA Report On Regulation and Oversight

The Association for Molecular Pathology responded to the FDA’s call for oversight of laboratory developed tests, rebutting 20 case studies published by the federal agency that illustrated possible harms inflicted on patients when laboratories did not follow FDA requirements.

The AMP said the agency’s collection of case studies “grossly misrepresents the public health concerns of laboratory developed testing procedures,” and said that FDA oversight would likely prevent few of the potential patient harms.

In the case of clinical trials performed at Duke University using a faulty genomics predictor to assign cancer treatment to individual patients, the AMP said that that test did not cause patient harm, and was not used in a clinical setting.

Funding Opportunity

AACR and Bayer Offering Research Grants

The American Association for Cancer Research and Bayer announced the 2016 AACR-Bayer Innovation and Discovery Grants program for meritorious projects that examine novel targets and biomarkers in oncology research.

In Brief

  • St. Jude to open new Graduate School for Biomedical Sciences
  • Research!America unveils 2016 policy wish list
  • Memorial Sloan Kettering opens outpatient surgery center
  • Inova and George Mason University form research partnership
  • St. Jude receives $20 million commitment from Steven & Alexandra Cohen Foundation
Drugs and Targets

  • FDA grants Breakthrough Therapy Designation to Boehringer Ingelheim TKI Inhibitor in NSCLC
  • Stem Cell Theranostics and CapellaBio launch collaboration on cardiotoxicity
  • Amgen enters into agreement with GSK to reclaim rights to Prolia, XGEVA, and Vectibix
20160108 - Jan. 8, 2016
December 2015PDF

 

 Multiple Myeloma

Head-to-Head Phase III Study Demonstrates Kyprolis Nearly Doubles PFS over Velcade

Results from the phase III head-to-head ENDEAVOR study comparing Kyprolis to Velcade in patients with relapsed multiple myeloma showed that patients treated with Kyprolis achieved progression-free survival of 18.7 months compared to 9.4 months (HR=0.53; 95% CI: 0.44, 0.65; p<0.0001).

The findings demonstrated that patients treated with Kyprolis (carfilzomib) plus dexamethasone lived twice as long without disease worsening as those treated with Velcade (bortezomib) plus dexamethasone.

Also:

 Leukemia

AML Patients Receiving PKC412 Midostaurin Show 23% OS Improvement in Phase III Trial

Adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia who received the investigational compound PKC412 (midostaurin), plus standard induction and consolidation chemotherapy, experienced a 23 percent improvement in overall survival (HR=0.77, p=0.0074), compared to those treated with standard induction and consolidation chemotherapy alone.

In the phase III RATIFY clinical trial, the median OS for patients in the PKC412 treatment group was 74.7 months (95% CI: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group.

The trial evaluated the addition of either PKC412 or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase; patients who achieved complete remission after consolidation chemotherapy continued treatment with PKC412 or placebo as a single agent for up to one year.

 Drugs and Targets

FDA Approves Opdivo Injection for Renal Cell Carcinoma Patients

FDA approved Opdivo (nivolumab) injection for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

In the CheckMate-025 trial, patients treated with Opdivo achieved a median OS of 25 months (95% CI: 21.7-not estimable) versus 19.6 months (95% CI: 17.6-23.1) for everolimus, a current standard of care (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]), based on a prespecified interim analysis. In the study, the safety profile was consistent with prior Opdivo studies.

Also:

Pancreatic Cancer

 Liver Metastases

Phase III Melphalan Trial Shows Improvement in Hepatic-PFS in Melanoma Patients

20151225 - Dec. 25, 2015