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November 2014PDF

 Melanoma

PD-1 Checkpoint Inhibitor Opdivo First to Demonstrate Survival Benefit in Phase III


A study comparing Opdivo to dacarbazine chemotherapy in treatment naïve advanced melanoma patients marks first PD-1 immune checkpoint inhibitor to demonstrate a survival benefit in a phase III trial.

The trial, CheckMate-066, met its primary endpoint of overall survival, with median OS not reached in the Opdivo (nivolumab) arm, compared to 10.8 months in patients receiving dacarbazine chemotherapy.

The one-year survival rate was 73 percent for Opdivo vs. 42 percent for DTIC, and there was a 58 percent decrease in the risk of death for patients treated with Opdivo (HR: 0.42, p<0.0001).

Also:

 Ovarian Cancer

Phase III Trebananib Trial Fails OS Endpoint In Recurrent Platinum-Resistant Ovarian Cancer

Top-line secondary endpoint results from the phase III TRINOVA-1 trial in women with recurrent platinum-resistant ovarian cancer did not demonstrate a statistically significant improvement in overall survival. The study evaluated trebananib plus paclitaxel versus placebo plus paclitaxel.

Median overall survival was 19.3 months in the trebananib arm versus 18.3 months in the control arm. The data will be submitted to a future medical conference and for publication according to Amgen, trebananib’s sponsor.

In the previously reported primary endpoint analysis, the data demonstrated a statistically significant difference in progression-free survival for trebananib. In that analysis, patients treated with trebananib showed a 34 percent reduction in the risk of disease progression or death (HR = 0.66, 95 percent CI, 0.57, 0.77, p<0.001). The median progression-free survival was 7.2 months in the trebananib arm versus 5.4 months in the control arm.

 Glioblastoma

Phase III Tumor Treating Fields Trial Halted Following Positive Results in Interim Analysis

A phase III trial of Tumor Treating Fields was terminated early following early success detailed in an interim analysis. The trial evaluated patients with newly diagnosed glioblastoma being treated with the NovoTTF-100A System, developed by Novocure, in combination with standard-of-care temozolomide.

The treatment extended both progression-free survival and overall survival compared to temozolomide alone. The trial’s independent data monitoring committee recommended terminating the trial early and allowing all control patients to cross over to the treatment arm.

 Non-Small Cell Lung Cancer

 Prostate Cancer
Galeterone Shows Potential In CRPC AR Variants, Study Says
 NCI CTEP-Approved Trials for the Month of November
 FDA News

  • Cyramza approved in advanced gastric cancer

  • Lymphoseek indication expanded to include mapping in solid tumors

  • Fast Track designation granted to MM-398 adenocarcinoma of the pancreas

  • Orphan Drug designation granted to JCAR015 in ALL

  • FDA taking public comment on “first generic” ANDA processes

20141201 - Dec. 1, 2014
ISSUE 44 – NOV. 21, 2014PDF

As FDA Weighs its Options on Morcellation, Debate Erupts Over Harvard Device Study

Here is what we know: A surgical device used to perform about 100,000 hysterectomies and myomectomies every year in the U.S. has been shown to spread cells from undetected or missed uterine cancers—rapidly upstaging the disease.

And here is what we don’t know: What will FDA do about it?

The agency is under pressure to respond to the growing outcry from patient advocates, who want a ban on the device.

Conversation with The Cancer Letter

Demetri: Morcellation Worsens Outcomes In Patients with Undiagnosed Cancers

As an oncologist who treats sarcoma, George Demetri has seen the adverse consequences of power morcellation, the surgical technique widely used to perform laparoscopic hysterectomies and remove putative fibroids.

In a small minority of cases, these fibroids instead represent unsuspected malignancies—including rare and aggressive leiomyosarcomas—which were impossible to detect prior to the morcellation procedure.

The Cancer Letter is taking a Thanksgiving Break.

The next issue will be published on Dec. 5.

CPRIT Awards 32 Grants

The Cancer Prevention and Research Institute of Texas awarded 20 grants through its product development program, five grants through its prevention program, and seven recruitment grants through its research program, totaling more than $65 million.

ASCO Proposes Principles For Future Debate on Medicaid

The American Society of Clinical Oncology has proposed a set of principles for shaping future debate of the role of Medicaid.

Obituary

Connie Curran, 67, C-Change Executive Director

Connie Curran, 67, the first executive director of C-Change, died Nov. 10.

C-Change brings together leaders in cancer from the public, private, and not-for-profit sectors. 

Curran was born in Berlin, Wis. She held degrees from the University of Wisconsin, DePaul University, and Northern Illinois University. She also is a graduate of Harvard University Business School’s Owner/President Management program.

FDA News

photoIn Brief

  • D. Gary Gilliland Named President and Director of Fred Hutchinson Cancer Research Center

  • Mark Gilbert named chief of Neuro-Oncology Branch at NIH

  • Bert Vogelstein awarded Warren Triennial Prize by Massachusetts General Hospital

  • Susan Mayne appointed director of FDA Center for Food Safety and Applied Nutrition

  • Merck KGaA and Pfizer Inc. to co-develop anti-PD-LI antibody

  • NYU Langone Medical Center and Lutheran Medical Center to create integrated healthcare network

  • Dana-Farber Cancer Institute and Astellas Pharma Inc. announce three-year collaboration

  • Tapimmune Inc. and Vaccine & Gene Therapy Institute of Florida form partnership

  • St. Jude Children’s Research Hospital opens Marlo Thomas Center

  • Karmanos Cancer Institute honored by Michigan Cancer Consortium

20141121 - Nov. 21, 2014
ISSUE 43 – NOV. 14, 2014PDF

CMS Inserts Unprecedented Conditions Into Medicare Coverage of Lung Screening

CT screening of the lungs of current and former heavy smokers is about to become a Medicare benefit.

A proposed decision published Nov. 10 has inserted some unprecedented conditions into its decision to cover screening:

Beneficiaries would have to go through counseling, and health professionals would be required to provide documentation that “shared decision-making” took place. The Centers for Medicare and Medicaid Services has never mandated shared decision-making as a gateway to paying for a service.

Guest Editorial

Brawley: CMS Got it Right in Lung Cancer Screening Decision

This week the Centers for Medicare & Medicaid Services issued a proposed rule stating that the scientific evidence was sufficient to support reimbursement for counseling on the risks and benefits of lung cancer screening as well as lung cancer screening with low dose computed tomography in high risk individuals and once per year. CMS will pay for such services when provided to beneficiaries at high risk for lung cancer and when provided by physicians and centers with specific qualifications.

FDA News

CPRIT Sets Funding Priorities For Rare and Pediatric Cancers

The Cancer Prevention & Research Institute of Texas is adding rare cancers and childhood cancers to its list of funding priorities, according to a draft program report.

The Texas legislature requires the oversight committee of the $300 million state-funded program to establish funding priorities on an annual basis. This is the first time these priorities are articulated and vetted in a public setting, officials say.

CDC: About 8 Million Women Skipped Cervical Cancer Screening in the Past 5 Years

About eight million women ages 21 to 65 years have not been screened for cervical cancer in the past five years, according to the Centers for Disease Control and Prevention. More than half of new cervical cancer cases occur among women who have never or rarely been screened.

2015 Breakthrough Prize Winners Announced at Gala

The Breakthrough Prize Foundation announced the recipients of its prizes in life sciences and fundamental physics, who will receive awards of $3 million.

photoIn Brief

  • Susan O’Brien to move to UC Irvine Health

  • Rosemarie Henson named senior vice president for prevention and early detection of the American Cancer Society

  • Michael Bishop to receive award from the Van Andel Research Institute

  • Antje Hoering named CEO of Cancer Research and Biostatistics

  • Nancy Hesse named chief nursing officer of Cancer Treatment Centers of America

  • Kathleen Green appointed associate director of basic sciences research at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center

  • Nancy Weigel named editor-in-chief of the journal Hormones and Cancer

  • American Society of Clinical Oncology forms new clinical affairs department

  • Community Oncology Alliance publishes report on closings of cancer clinics

  • Harrington Discovery Institute and University of Oxford form affiliation

  • Dana-Farber Cancer Institute and Astellas Pharma Inc. announce three-year collaboration

  • AstraZeneca, Pharmacyclics Inc., and Janssen Research & Development LLC to collaborate on MEDI4736 and Imbruvica trials

20141114 - Nov. 14, 2014