Genentech announces results of cancer drug trial
SOUTH SAN FRANCISCO, Calif. — Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.
Genentech announced Friday the results of the phase-3 "EMILIA" trial of trastuzumab emtansine in patients with an aggressive form of the disease that had spread to other parts of the body. The study enrolled 991 patients with HER2-positive breast cancer that had spread to other parts of the body who had previously taken the drug Herceptin (trastuzumab) and the chemotherapy drug taxane.
The patients were compared with those who received GSK’s Tykerb (lapatanib) and Genentech’s chemotherapy drug Xeloda (capacitabine).
The company also is conducting two other phase-3 trials dubbed "MARIANNE" and "TH3RESA."
Express Scripts struck a match to the merger debate after suggesting approval imminent
WHAT IT MEANS AND WHY IT’S IMPORTANT — When Express Scripts filed with the Securities & Exchange Commission that its merger with Medco could close as early as the week of April 2, that seemed to set off a firestorm of activity. Reports were published suggesting the Federal Trade Commission decision was imminent, and what’s more that the agency would decide in favor of the merger. Speculative day traders Wednesday morning pushed the opening stock prices across both Express Scripts and Medco higher by 3.9% and 5%, respectively. The anti-merger coalition Preserve Community Pharmacy Access NOW! hosted a press conference asking state attorneys general to do what the FTC might not — block the merger in the courts. And two trade associations representing the entirety of retail pharmacy did exactly that — filed suit in Pittsburgh to block the merger.
(THE NEWS: NACDS, NCPA, nine retail pharmacy companies sue to block ESI-Medco merger. For the full story, click here.)
Still, 40% of DSN online readers don’t think the FTC decision will come next week; they think that the FTC decision will extend beyond the 30-day period. (To vote yourself, click here.) Incidentally, share prices across both Express Scripts and Medco also have dropped slightly from their Wednesday open high, but the stocks still were trading at a 1.2% and 1.4% respective premium to Tuesday’s close as of Friday afternoon. The 60% remainder of DSN readers who think the FTC decision will come sooner than later are split pretty evenly as to which direction the FTC will decide the week of April 2 — with only a handful more votes on the side of an approved merger.
What was perhaps overlooked in all of this was the fact that the FTC did testify Wednesday morning that there certainly was an anticompetitive element in the relationship between pharmacy benefit managers and independent pharmacy. Before a House committee hearing arguments regarding the Preserving Our Hometown Independent Pharmacies Act of 2011, the FTC testified that waiving antitrust requirements for independents would result in higher drug prices because, get this, the community pharmacies would be better able to negotiate more favorable reimbursement terms. What the FTC did not testify was that in place of that better negotiating position the status quo for those pharmacies is to be force-fed a take-it-or-leave-it proposition on what will amount to — if the merger is approved — almost as much as two-thirds of the independents’ prescription business.
Beyond trending stock prices and the line on the will-it/won’t-it/when-will-it-happen DSN poll, here are the numbers that should stick with you as this story continues to play out the week of April 2. The Express Scripts-Medco books, combined, represent more than half (as high as 60%) of the prescription business of some of the plaintiffs in the suit filed Thursday. Across the nation both Express Scripts and Medco represent 155 million lives, or 49.5% of every man, woman and child in the United States as of Friday afternoon. As many as 78 Congress leaders have written the FTC to say, "Wow, this really isn’t such a good idea, this merger." And as many as 30 state attorneys general are investigating the question, "We hear this is bad, but how bad can it be for my state?"
Report: Cancer death rates continue to decline
ATLANTA — Mortality rates from all cancers combined continued to drop between 2004 and 2008 among men, women and children, according to the annual "Report to the Nation on the Status of Cancer, 1975-2008."
In addition to the decrease in death rates, which saw on average 1.6% decrease per year between 2004 and 2008, the overall incidence of cancer among men decreased by an average of 0.6% per year during the period, decreased 0.5% per year for women from 1998 through 2006 (with rates leveling off from 2006 through 2008) and decreased 1.3% per year between 2004 and 2008 among children ages 19 years and younger, the report’s researchers, which are from the Centers for Disease Control and Prevention, the North American Association of Central Cancer Registries, the National Cancer Institute and the American Cancer Society said.
"The continued declines in death rates for all cancers, as well as the overall drop in incidence, is powerful evidence that the nation′s investment in cancer research produces lifesaving approaches to cancer prevention, screening, diagnosis, and treatment," NCI director Harold Varmus said. "But it is also important to note that investments we make today are critical if we hope to see these declines in incidence and death from cancer reflected in future Reports to the Nation."
Despite these recorded declines, the report’s researchers noted that such factors as excess weight and lack of physical activity can increase one’s cancer risk and cited certain cancers as being associated with being overweight or obese, as well as not being sufficiently physically active.
"In the United States, 2-in-3 adults are overweight or obese and fewer than half get enough physical activity," American Cancer Society CEO John Seffrin said. "Between children and youth, 1-in-3 is overweight or obese, and fewer than 1-in-4 high school students get recommended levels of physical activity. Obesity and physical inactivity are critical problems facing all states. For people who do not smoke, excess weight and lack of sufficient physical activity may be among the most important risk factors for cancer."
Additional findings of the report included:
Although mortality rates declines, cancer incidence rates increased 0.6% per year from 2004 through 2008, continuing trends from 1992, among children ages 19 years and younger;
Among racial and ethnic groups, the highest cancer incidence rates between 2004 and 2008 were among African-American men and white women. Cancer death rates from 2004 through 2008 were highest among African-American men and African-American women, but these groups showed the largest declines for the period between 1999 and 2008, compared with other racial groups;
In addition to drops in overall cancer mortality and incidence, this year’s report also documents the second consecutive year of decreasing lung cancer mortality rates among women. Among men, lung cancer incidence has decreased since the early 1990s.
The new report appears early online in the journal Cancer and will appear in print in the May issue.