Synta Announces Results on Ganetespib Across a Range of Malignancies at the American Association for Cancer Research (AACR) Annual Meeting - MarketWatch

Synta Announces Results on Ganetespib Across a Range of Malignancies at the American Association for Cancer Research (AACR) Annual Meeting - MarketWatch:

Clinical trial of experimental drug targeting mutation in thyroid cancer shows clinical benefit — UNC Lineberger Comprehensive Cancer Center

by Mary Ruth Helms — last modified Apr 02, 2012 04:42 PM

Chapel Hill - In a clinical trial of an experimental drug to treat thyroid cancer, UNC and six other institutions report the first evidence in this tumor that targeting therapy to an oncogene documented to be present in the patient receiving therapy may be associated with clinical benefit.

Neil Hayes, MD, is the UNC principal investigator and first author of the study.

UNC scientists partnered in a clinical trial using the experimental drug selumetinib to treat advanced cases of the most common type of thyroid cancer called papillary thyroid cancer. Selumetinib targets and blocks the molecular pathway by which an oncogene called BRAF is activated. Up to 50 percent of thyroid cancers harbor this single gene alteration-called BRAF mutation- that is blocked by the drug.

In the trial, patients’ tumors were tested to confirm the mutation, and therapy was begun. Patients with the mutation who took the drug tolerated it well and patients without the mutation had no clinical benefit from the drug.

“We investigated the safety and effectiveness of selumetinib in patients with advanced thyroid cancer and found that in patients without the BRAF mutation the drug showed no evidence of activity.  However, when we focused the evaluation to the 50 percent patients with the abnormal gene, we saw striking differences in the patient responses,” says Neil Hayes, MD, MPH, the UNC principal investigator and first author of the study.   Because of the small size of the trial, this observation requires additional studies, but has powerful implications for the design of future studies and the drugs that should be considered. Hayes is associate professor of medicine and a member of UNC Lineberger Comprehensive Cancer Center.

“We feel this provides the first evidence in thyroid cancer that targeting this commonly altered pathway may have resulted in benefit for only the patients whose tumors demonstrated the mutation.  When speaking about personalized cancer therapy, this is the kind of example we are looking for.” Their results were published in the April 1, 2012 issue of the journal Clinical Cancer Research.

The Phase 2 trial involved 39 patients with iodine-refractory papillary thyroid cancer for which there are few therapeutic options and no consensus standard of care. Radioactive iodine therapy is one treatment for papillary thyroid cancer when patients are given a large dose of the substance, killing thyroid cells and the cancer.

The only FDA approved drug to date used to treat the advanced stage of disease isn’t always beneficial and has many side effects.  A number of newer drugs have shown striking promise, but these work through a different mechanism and FDA approval is generally still pending.

Thyroid cancer incidence is increasing, rising 5 to 6 percent annually.  The most common type is papillary, comprising 70 to 80 percent of the cases.  Although the prognosis is very good for papillary thyroid cancer if detected early with an overall 10-year survival rate of 98 percent, once the cancer is locally advanced or metastatic or no longer amenable to surgery, the survival rate declines.

Other UNC authors are: Amy Lucas, MD; Dominic Moore, MPH; Arif Sheikh, DBSc, MD; Janelle Hoskins, PhD; Michele Hayward, RD; Ni Zhao, MS; Wendi O’Connor, MD; and Karen Weck, MD.

Other institutions are: University of Chicago Medical Center; Fox Chase Cancer Center, Philadelphia; Princess Margaret Hospital Toronto, Ontario; Vanderbilt University, Nashville; Moffitt Cancer Center and Research Institute, Tampa; Johns Hopkins School of Medicine, Baltimore.

Funding for the study was provided by the National Cancer Institute.

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Analysts Differ on Role of 'Individual Mandate' to Health-Reform Law

WEDNESDAY, March 28 (HealthDay News) -- Striking down the so-called "individual mandate," the most controversial provision of the Affordable Care Act, should the Supreme Court do so, wouldn't deliver a death blow to the health-reform package. But, it would alter projected costs and consumer participation, health policy experts said.

"If the individual responsibility provision is struck down, it is important that mechanisms are in place to ensure there's a balance in insurance pools to make sure younger, healthier people participate so premiums don't escalate," said Ron Pollack, executive director of Families USA, a national advocacy group for health-care consumers.

Pollack, who supports the Affordable Care Act, said other methods of attaining broad participation exist to hold down insurance costs, but it's premature to discuss them. The individual mandate -- which imposes penalties on those who don't buy insurance -- is the most effective formula, he said.

"Massachusetts has the individual insurance provision, and the experience in Massachusetts shows it does work," Pollack said.

It's estimated that at least 30 million uninsured Americans would gain health insurance under the law, 16 million as a result of the individual mandate.

Pollack said that even without the individual mandate, the health-care legislation includes other provisions for extending coverage to millions of people currently without insurance.

For instance, Medicaid eligibility will expand to include citizens and legal residents with annual incomes up to 133 percent of the federal poverty level -- about $14,850 for a single adult and $30,650 for a family of four in 2012. And federal tax subsidies will enable certain other people to buy coverage, Pollack said. It's estimated that Medicaid expansion would add 16 million people to the rolls of the insured.

John Goodman, president of the National Center for Policy Analysis, which opposes the health-reform law, said he anticipates affordability problems with or without the individual mandate.

"The mandate itself is pretty weak to begin with," he said. "I think people are overestimating its importance."

While the provision calls for most American adults to obtain health insurance, people who don't earn enough to file federal income tax returns and many others are exempt, Goodman pointed out. "That's millions of people," he said.

Goodman also said the penalties for not buying insurance are small compared to the price of insurance. That might tempt some people to "game the system" -- waiting until they're sick to buy insurance and canceling it when they're well -- "which will make it very expensive," he said.

Enforcement of the individual mandate will be left to the Internal Revenue Service, Goodman said, adding he doubts the agency will pursue violators aggressively. Fines will be phased in until 2016, when individuals refusing to obtain insurance would pay $695 and families $2,085 or 2.5 percent of total taxable income, according to figures from the Henry J. Kaiser Family Foundation.

For many people, that's a lot less than the cost of insurance, Goodman said. Although it varies by region and age, typical insurance premiums in 2016 are expected to average about $5,800 for an individual and $15,200 for a family of four, according to Goodman's analysis of figures from the Congressional Budget Office.

"This whole approach is flawed," Goodman said. He suggested that the architects of the Affordable Care Act should have taken cues from Medicare. "If you look at Medicare Part B premiums and Medicare Part D premiums, provisions and methods are in place to prevent people from gaming the system."

Pollack remains unfazed by that argument. If the penalties aren't strong enough, he said, "that can be corrected."

The RAND Corporation, a nonprofit research organization, predicts that the cost of buying policies through new insurance exchanges would increase only slightly if the individual mandate provision were removed. (The exchanges will be created to help small businesses and individuals purchase insurance through a more organized and competitive market.)

However, because fewer people would buy insurance if the mandate were eliminated, costs borne by the federal government would rise, the researchers said.

Eliminating the individual mandate would cut the predicted number of Americans buying new health coverage in 2016 from 27 million to 15 million and increase an individual's cost of buying insurance by 2.4 percent, according to the RAND analysis.

But Christine Eibner, an economist at RAND, said government spending for each person newly enrolled in a health insurance plan would more than double, reaching nearly $7,500 a person.

"Without the individual mandate, the government would have to spend more overall to insure a lot fewer people," Eibner said in a RAND news release.

More information

The U.S. Department of Health and Human Services outlines how women will fare under the Affordable Care Act.

SOURCES: Ron Pollack, executive director, Families USA, Washington, D.C.; John Goodman, president, National Center for Policy Analysis, Washington, D.C.; Feb. 16, 2012, news release, RAND Corporation

Copyright © 2012 HealthDay. All rights reserved.

BBC News - Cancer: 'Book of knowledge' published

By Helen BriggsBBC News

The first volume of a "book of cancer knowledge" has been published, which scientists say will speed up the search for new cancer drugs.

The "encyclopaedia" details how hundreds of different cancer cells respond to anti-cancer agents.

UK, US and European researchers say the data, published in Nature, is a step towards tailoring cancer medicine to a patient's genetic profile.

A cancer charity said the work would help in testing new cancer drugs.

Cancer cells grown in the laboratory are an essential tool in cancer research.

Hundreds of different cell lines exist, allowing scientists to study the effect of new cancer drugs on the human body.

Continue reading the main story

Cancer medicines linked to genetic profiles

• A new drug called vemurafenib offers hope to malignant melanoma patients with certain genetic markers
• Erlotinib helps some lung cancer patients by targeting a receptor found in some tumours. Another new drug, crizotinib, tackles lung cancer expressing the ALK gene
• The breast cancer drug Herceptin is given to patients with an overactive HER2 gene
• The cancer drug imatinib blocks cancer growth in white blood cells of patients with chronic myeloid leukaemia carrying a certain gene mutation

Now, a team at the Wellcome Trust Sanger Institute near Cambridge and various cancer institutes around the world have released two papers cataloguing data on hundreds of cancer cell lines.

The UK team, working with colleagues in the US, Paris and Switzerland, screened more than 600 cancer cell lines with 130 drugs, identifying genetic signatures linked with drug sensitivity.

Already clues are emerging that could be of benefit to patients, including the discovery that a rare bone cancer in children (Ewing's sarcoma) appears to be vulnerable to certain drugs.

Personalised medicine

Dr Mathew Garnett of the Sanger Institute is lead researcher on one of the two papers published in the journal Nature.

Continue reading the main story

“Start Quote

We're trying to get smarter about understanding what the right drug is using the genetic profile in each tumour”

Dr Levi GarrawayOncologist

He told the BBC: "It's bringing together two very large and very powerful data sets and asking which cell line is the most sensitive and what is behind that sensitivity.

"This is the largest study of its kind linking drug response with genetic markers. You need these very large studies to identify small subsets of cells that are sensitive to drugs."

Dr Levi Garraway of The Broad Institute of Harvard and MIT, Cambridge, US, is a senior member of the research team behind the second paper, which profiled 24 drugs across nearly 500 cell lines.

He told the BBC: "Developing this large cell-line resource with all the associated genetic details is another piece in the pie to get us to our goal of personalised cancer medicine.

"We're trying to get smarter about understanding what the right drug is using the genetic information in each tumour. This is a stepping stone along the way."

The next step is use the information to help decide on tailored treatments for cancer patients.

This would involve getting a genetic "fingerprint" of their tumour, which could be matched to information in the database.

Some cancer drugs are already available for individuals with a certain genetic makeup.

The best known is Herceptin, a breast cancer drug that works in patients with an overactive HER2 gene.

Professor Charles Swanton, based at Cancer Research UK's London Research Institute, said the papers were "an invaluable resource" that provided "extremely useful intelligence" for cancer researchers.

He added: "This new resource will help speed up cancer research and may well begin to guide further developments in personalised cancer medicine."

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