By Allison Connolly
The drug, formerly known as Stimuvax, failed to improve patient survival significantly in a late-stage study of more than 1,500 patients, Darmstadt, Germany-based Merck said today in a statement. Further research will focus on smaller groups of patients who showed positive response to the drug, and results will be discussed with regulators in coming months, it said.
Merck fell the most in seven months after the latest setback in an 11-year effort to develop L-BLP25, a drug originated by U.S. partner Oncothyreon Inc. (ONTY), into a marketable product. While Merck is implying that there may be some hope for the vaccine, it’s still too early to say that, and the company would probably have to conduct further trials, Edouard Aubery, an analyst with Equinet AG, said in a phone interview today.
“This could have been a potential blockbuster, but now it’s been taken off the table,” he said. Aubery had estimated peak annual sales at 1 billion euros ($1.32 billion), with only a 25 percent probability that the vaccine would make it to market after Merck signaled that L-BLP25 was a “high-risk project.”
Merck’s Start trial enrolled patients with advanced, inoperable lung cancer whose disease was stable following chemoradiotherapy. The U.S. Food and Drug Administration put the program on hold in March 2010 after a patient developed a brain infection. Merck was allowed to resume two lung cancer trials in June 2010 and scrapped a test of the vaccine in breast cancer.
“It is disappointing” that the testing “did not meet its primary endpoint,” Frances Shepherd, a medical professor at the University of Toronto who coordinated the trial, said in the statement. “However, notable treatment effects were observed in certain subgroups of patients and warrant further investigation of L-BLP25.”
Germany's Merck says trial for lung cancer drug fails to improve survival rates
by: Associated Press
German pharmaceutical company Merck KgaA says a late stage trial of a new lung cancer drug has failed to meet expectations.
The company, based in Darmstadt, says the drug Stimuvax did not improve the overall survival of patients in the phase III study.
Merck shares fell 3.1 percent to (EURO)98.20 ($129.41) after the announcement early Wednesday.
The company is a separate entity from Merck & Co., which is based in the U.S.
DrugRisk Center: Merck Withdraws Cancer Drug As NuvaRing Lawsuits Grow
By PRWEB
The news for Merck comes as litigation surrounding their popular NuvaRing contraceptive device has grown to 1,028 cases, according to the 2012 Statistical Analysis from the Judicial Panel on MultiDistrict Litigation.** The formal case is known as In re: NuvaRing Products Liability Litigation, No. 08-md-1964, JPML, Eastern District Missouri.
Experts have related vaginal rings like NuvaRing to higher blood clot risks than with traditional birth control pills.
The British Medical Journal published a Danish study on May 10, 2012 linking vaginal rings like NuvaRing to as much as a 90% increased risk of blood clots over oral contraceptives. On June 14, 2012, the New England Journal of Medicine also published a study finding vaginal ring contraceptives could relate to a 2.5 to 3-fold increased risk of blood clots.
So far, the FDA has received more than 1,000 reports of blood clot injury or death in patients using NuvaRing, according to an article in CBS News San Diego on September 21, 2012.
U.S. District Judge Rodney Sippel, who presides over the NuvaRing lawsuits moved to the Missouri federal court from around the country, recently issued an order postponing the start of trials from May 6 to July 8, 2013.
Merck's New Type of Cancer Drug Shows Promise
By RON WINSLOW
The drug, known as MK-3475, is among a new class of agents called PD-1 inhibitors. Researchers believe the medicines work by releasing a biological brake that shields tumor cells from attack by the immune system. In interfering with the action of a protein called PD-1, the drugs enable the immune system to home in on cancer cells.
Researchers reported data from 85 patients with advanced melanoma treated with MK-3475 and followed for at least 12 weeks. They said 43, or 51%, of patients had an "objective response" to the medicine, including eight, or 9%, who had a complete response, meaning their cancer couldn't be detected with imaging tests.
"It's a very exciting area," said Patrick Hwu, head of melanoma oncology at MD Anderson Cancer Center in Houston. "I don't know what exact drugs are going to make it, but it's a blockbuster pathway."
There are challenges. Turning on the immune system risks exposing normal tissue to attack. In the new Merck study, seven patients developed side effects believed to be immune-response-related, including a 96-year-old man who died of a heart attack while being treated for inflammation of lung tissue—a condition called pneumonitis—that likely resulted from the cancer treatment.
But researchers say such responses generally can be managed with steroid treatments and that so far the agents have proven relatively safe.