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ISSUE 44 – DEC. 4, 2015PDF



Mary Pazdur, 63, Dies of Cancer;

What Her Husband Has Learned

The job interview wouldn’t last more than 15 minutes, Richard Pazdur believed.

So, on a June morning in 1999, his wife Mary settled down to wait at a restaurant near the FDA buildings alongside Rockville Pike.

The restaurant turned out to be Hooters, and Mary ended up spending three hours at the joint known for all-you-can-eat chicken wings served by scantily clad waitresses known as Hooters Girls.

“How much Hooters coffee can you drink?” Mary said frequently, retelling the story of her introduction to FDA, Washington and cancer politics.

Rick’s Search for Meaning

On Nov. 17, Richard Pazdur, director at the FDA Office of Hematology and Oncology Products, spoke about the role that has been thrust upon him: that of a “regulator/advocate.”

“What we’re seeing now is not a patient voice but a patient cry—wanting to have their position heard,” said Pazdur, speaking at a Washington conference sponsored by Friends of Cancer Research.

NCI Director’s Report

Lowy: Higher RPG Success Rates in 2015;

Continuing Resolutions Will Slow Progress

NCI awarded about 635 R01s in 2015, up from 629 in 2014, said NCI Acting Director Doug Lowy at a recent joint meeting of the National Cancer Advisory Board and the NCI Board of Scientific Advisors.

The number of R01 awards fell short of pre-sequestration levels, but there has been a substantial increase in R21 applications—from 225 in 2012 to about 355 in 2015.

Funding Opportunity

Debbie’s Dream Foundation Offering $200,000 in Grants

Debbie’s Dream Foundation: Curing Stomach Cancer launched two research grants totaling $200,000 for the 2015-2016 grant cycle. A Career Development Award for $150,000 and a Young Fellowship Grant for $50,000 are being offered.

In Brief

  • Jennifer Nam Choi named chief of oncodermatology at Northwestern Memorial
  • Robert Hauser named vice president of clinical analytics at Cancer Treatment Centers of America
  • Mia Levy to be director of health information and strategy at Vanderbilt-Ingram Cancer Center
  • City of Hope announces three personnel changes
  • David Flockhart, board member of the Personalized Medicine Coalition, died Nov. 26
  • Fox Chase-Temple Health form collaboration with Accutest Research Labs in India
  • Manipal Hospitals to use IBM Watson technology
  • ASTRO publishes template for long-term survivor plans
  • West Cancer Center opens its East Campus
  • National Health Care Anti-Fraud Association names it’s 2015 Investigation of the Year
Drugs and Targets

  • FDA approves Opdivo in renal cell carcinoma
  • European Commission grants marketing authorization for Kyprolis in multiple myeloma
  • EMA accepts anamorelin application for review
  • MD Anderson and Boehringer Ingleheim announce collaboration
  • Morphotek and Targeted Alpha Therapy Group to collaborate in ovarian cancer
  • Roche and Upsher-Smith Laboratories to develop VAP-1 inhibitor
  • Caris Life Sciences and Syapse to collaborate on genomic information
20151204 - Dec. 4, 2015

NCI CTEP-Approved Studies for the Month of November

 

The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.

 

Phase I

CITN-12: Phase I Study of MK-3475 (Pembrolizumab) in Patients with Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant Neoplasm. Cancer Immunotherapy Trials Network; Uldrick, Thomas S. (301) 402-6296

 

PBTC-047: Phase I Trial of Panobinostat in Children with Diffuse Intrinsic Pontine Glioma. Pediatric Brain Tumor Consortium; Monje, Michelle. (650) 736-0885

 

Phase II

ADVL1522: A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; IND#: 126953, NSC#: 783609) in Children with Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma. Children’s Oncology Group; Geller, James Ian. (513) 636-6312 X 6312

 

AOST1321: Phase 2 Study of Denosumab (IND# 127430, NSC# 744010), a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma. Children’s Oncology Group; Janeway, Katherine Anne. (617) 632-4994

 

AOST1421: A Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 (Dinutuximab, NSC# 764038, IND# 4308) in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma. Children’s Oncology Group; Hingorani, Pooja. (602) 546-0920

 

Other Phases

AALL14B7-Q: Screening Low-Hypodiploid B-ALL for Pro-B Phenotypes. Children’s Oncology Group; Carlson, Christopher. (206) 667-7034

 

AAML15B5-Q: The Role of Id1 in Leukemogenesis. Children’s Oncology Group; Wang, Lan. (305) 243-8920

 

AEWS15B1-Q: Development of Specific and Reversible LSD1 Inhibitors for Ewing’s Sarcoma. Children’s Oncology Group; Lessnick, Stephen L. (415) 476-3831

 

AEWS15B1-Q: Development of Specific and Reversible LSD1 Inhibitors for Ewing’s Sarcoma. Children’s Oncology Group; Lessnick, Stephen L. (415) 476-3831

 

ANHL14B1-Q: Genomic Analysis of Pediatric Anaplastic Large Cell Lymphoma ALCL. Children’s Oncology Group; Leventaki, Vasiliki. (901) 595 7531

 

APEC14B1: The Project: EveryChild Protocol: A Registry, Eligibility Screening, Biology and Outcome Study. Children’s Oncology Group; Adamson, Peter C. (215) 590-6359

 

E1608T2: Inherited Markers as Predictors of Adverse Events and Survival Among Melanoma Patients Treated with Ipilimumab. ECOG-ACRIN Cancer Research Group; Nathanson, Katherine Leah. (215) 573-9840

 

S1417CD: Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer. SWOG; Shankaran, Veena (206) 288-7456

20151201 - Dec. 1, 2015
November 2015PDF

 

 Melanoma

Keytruda Shows Anti-Tumor Activity in Three Combinations and Phase III Trial

Merck presented three studies investigating the use of Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with three other immunotherapies—epacadostat, Imlygic (talimogene laherparepvec), and ipilimumab—in patients with advanced melanoma.

Keytruda showed anti-tumor activity in all three combinations studied. The findings were featured in separate oral presentations at the International Congress of the Society for Melanoma Research, in San Francisco.

Additionally, updated data presented from a phase III study of Keytruda as a single agent showed superior overall response rates and progression free survival compared to ipilimumab in ipilimumab-naïve patients, with twice as many patients achieving PFS on Keytruda compared to ipilimumab.

 Drugs and Targets

FDA Approves Ninlaro and Darzalex For the Treatment of Multiple Myeloma

FDA approved Ninlaro (ixazomib), developed by Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ixazomib is the first approved oral proteasome inhibitor.

The approval was based on an improvement in progression- free survival in a multicenter, randomized, double-blind, placebo-controlled trial enrolling 722 patients with multiple myeloma who had received one to three prior lines of therapy. Patients were randomized in a 1:1 ratio to either the combination of ixazomib, lenalidomide and dexamethasone (n=360) or the combination of placebo, lenalidomide and dexamethasone (n=362). Patients continued treatment until disease progression or unacceptable toxicity.

 Lymphoma

Lenalidomide-Rituximab Combination Shows Benefits in Mantle Cell Lymphoma

A combination therapy lacking many of the debilitating effects of traditional cancer treatment effectively manages mantle cell lymphoma, shrinking the malignancy and inducing remissions in the majority of patients, according to new research from Weill Cornell Medicine.

The phase II study demonstrated that lenalidomide, in combination with rituximab, provides an effective alternative to chemotherapy. More than 90 percent of patients in the small efficacy trial responded to the therapy, with their cancer shrinking by more than half, and two-thirds of that group had no evidence of detectable tumor growth after treatment.

Glioblastoma

ICT-107 Boosts Overall Survival by 10 Percent In Phase II Trial

 Childhood Cancer

Researchers: All Pediatric Patients, Regardless of Family History, Could Benefit from Genomic Screening

 Cancer Genomics

TCGA Researchers Identify 7 Subtypes of Prostate Cancer And 2 Drivers of Papillary RCC

 Lung Cancer

FDA Requests Data from Clovis For Rociletinib NDA in NSCLC

 NCI CTEP-Approved Studies for the Month of November
20151130 - Nov. 30, 2015