NCI Studying Biomarker Use in Lung Cancer Treatment
(BioWorld Today Via Acquire Media NewsEdge) Washington Roundup
WASHINGTON - The National Cancer Institute (NCI) has launched a 1,200-patient clinical trial to test whether biomarkers can be used to predict the clinical benefits of South San Francisco-based Genentech Inc.'s Tarceva (erlotinib) and Indianapolis-based Eli Lilly and Co.'s Alimta (pemetrexed) in patients with non-small-cell lung cancer (NSCLC).
The study, known as the Marker Validation for Erlotinib in Lung Cancer (MARVEL) trial, is attempting to definitively establish the future value of selecting patients for treatment based on the presence or absence of epidermal growth factor receptor (EGFR) activation.
EGFR can be increased in some lung cancers due to the presence of extra copies of its coding gene, which can result in activation of tumor growth. Drugs that block the activation could have a significant impact on lung cancer treatment.
Tarceva specifically targets EGFR, whereas Alimta blocks tumor cell growth by another mechanism.
Based on earlier studies, NCI researchers have hypothesized that patients with EGFR-positive lung cancer will benefit most from Tarceva, while those with EGFR-negative lung cancer are likely to respond better to Alimta.
Participants in the MARVEL trial will be tested for EGFR biomarker status and then randomized to treatment based on the test results. EGFR-positive and EGFR-negative patients will receive either Tarceva or Alimta, which are both approved in the U.S. for NSCLC, after they have received their initial standard chemotherapy.
The NCI said the study will incorporate genetic studies for Tarceva and Alimta that will be important to further identify patients with different sensitivity and toxicity profiles to those therapies.
In addition to the level of EGFR activation, the factors that appear to influence responsiveness to Tarceva include whether the resulting cancer cells are classified as adenocarcinomas, as opposed to squamous or other types of cell, female gender, Asian ethnicity and whether the patient was ever a smoker, according to the NCI.
The agency noted that no forward-looking study has been performed to definitively address which factors are most important.
MARVEL is the outcome of a 2006 collaboration between NCI, the FDA and the Centers for Medicare & Medicaid Services, known as the Oncology Biomarkers Qualification Initiative, which was designed to qualify biomarkers for use in clinical trials, with the goal of ultimately speeding new and better agents to the market.
"Because lung cancer is such a lethal disease and because it is particularly difficult to treat, especially if diagnosed in its later stages, the MARVEL trial is of major importance, because it could define, based on a single test, the best therapy for this disease," said NCI director John Niederhuber. "The future of moving highly targeted agents from the lab to the clinic will be heavily dependent on biomarkers for patient selection," he added.
Bailout Bill Contains Biotech Incentives
Tucked inside the government's $700 billion financial rescue package, passed by the House and Senate last week and signed by President Bush on Friday, was a provision extending by two years the federal research and development tax credit.
Jim Greenwood, CEO of the Biotechnology Industry Organization, said the R&D tax credit was needed for biotech firms as a "stabilizing influence" in the current climate of "precarious markets."
"Much of the promise of biotech therapies for autoimmune diseases, superbugs, biofuels and many other innovations depends on fostering innovative research through measures like the R&D credit," Greenwood said in a statement.
As the end of 2008 approaches, he said, biotechs face ever more uncertainty about their future, "specifically their ability to plan for investments in R&D here in the U.S."
Greenwood noted that the economic stabilization legislation includes an increase in the alternative simplified credit method rate, which he said would "strengthen and modernize the R&D credit, something that is long overdue."
Postal Worker Anthrax Plan Updated
The heads of the Departments of Health and Human Services and Homeland Security last week invoked their federal authority to seek a so-called emergency use authorization from the FDA to allow U.S. postal workers to obtain and keep antibiotic kits at their homes to protect them if they are enlisted to make door-to-door deliveries of antibiotics in the event of a anthrax attack.
The idea of having postal workers deliver antibiotics directly to U.S. residents has been kicked around since fall 2001, after five Americans died of inhalational anthrax.
Ironically, those who died had been exposed to anthrax spores that were sent in letters through the mail to several news media and two U.S. Democratic senators.
The delivery of antibiotics by postal workers eventually became part of HHS' Cities Readiness Initiative, a federally funded effort created in 2004 to prepare major U.S. cities and metropolitan areas to effectively respond to a large-scale bioterrorist event by dispensing antibiotics to their entire identified population within 48 hours of a decision to do so.
HHS and the U.S. Postal Service so far have tested the ability of letter carriers to quickly deliver door-to-door quantities of antibiotics from the Strategic National Stockpile - a federal cache of drugs and medical equipment designed to be deployed within 12 hours of a terrorist attack or other emergency - in Seattle, Philadelphia and Boston.
"In an anthrax attack, time is of the essence in preventing illness and death by getting antibiotics to those who may have been exposed," said HHS Secretary Michael Leavitt.
"By providing advance protection to letter carriers who volunteer to deliver antibiotics in an affected community, we can gain the benefits of the unique capabilities of the Postal Service to get much needed medicines to those who need it quickly," he added.
Leavitt said the "quick-strike capability" of using postal workers is intended to buy time for local and state public health authorities to establish points-of-dispensing, or PODs - sites for distributing medications or vaccines during a public health crisis.
The letter carrier, said Postmaster General John Potter, "has long been a reliable presence in America's neighborhoods. This important and potentially life-saving undertaking is a natural extension of what the carriers see as a service to their community."
Leavitt also issued a declaration under the Public Readiness and Emergency Preparedness Act to provide liability protection for activities related to developing, manufacturing, distributing, prescribing, dispensing, administering and using anthrax countermeasures in preparation for, and in response to, a potential anthrax attack.
The liability protection will help ensure full participation by the covered entities and "bolster response efforts," HHS said in a statement. n
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