New drug used to treat breast cancer heralded as 'quite groundbreaking'
By Catholic Online (NEWS CONSORTIUM)
4/6/2014 (2 years ago)
Catholic Online (www.catholic.org)
An important treatment option in the fight against breast cancer may be waiting in the wings. Researchers say a new type of drug could help prevent advanced breast cancer from worsening. The potential is great for breast cancer patients, and makes for a potential blockbuster product for Pfizer.
While Pfizer remains in the lead to bring this new class of drugs to market, Novartis has begun late-stage testing of its own CDK 4/6 inhibitor.
LOS ANGELES, CA (Catholic Online) - Said drug cut in half the risk that cancer would worsen, or progress, researchers said. The median time before the disease progressed or the women died was 20.2 months for those who received the drug, compared with 10.2 months for the control group.
"The magnitude of benefit we are seeing is not something commonly seen in cancer medicine studies," Dr. Richard S. Finn, a principal investigator in the study, says. Finn, an oncologist at the University of California, Los Angeles, called the results "quite groundbreaking."
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Known as palbociclib, the drug also appeared to prolong survival but not by a statistically significant amount. Those who received the drug lived a median of 37.5 months in contrast with 33.3 months for those in the control group.
The results from the Phase 2, or mid-stage, study were presented here at the annual meeting of the American Association for Cancer Research. Palbociclib is considered a jewel in Pfizer's product pipeline, with analysts predicting annual sales of billions of dollars. Amgen is entitled to an eight percent royalty on sales of the drug.
Some investors may have been letdown due to the drug, partly because they were not quite as good as interim results presented about halfway through the trial. At that point, the difference in median progression-free survival was 26.1 months for palbociclib versus 7.5 months for the control group.
Finn stresses that a statistically significant survival benefit should not have been expected at this point because only 61 of the 165 patients in the trial had died. Patients can use other drugs after leaving the trial, which can dilute any effect of palbociclib.
Palbociclib slows the proliferation of cancer cells by inhibiting the activity of two related enzymes involved in cell division; cyclin-dependent kinases 4 and 6.
While Pfizer remains in the lead to bring this new class of drugs to market, Novartis has begun late-stage testing of its own CDK 4/6 inhibitor. While breast cancer is the initial focus, the drugs are being tested for other cancers.
Breast cancer specialists not involved in the study were encouraged -- but expressed caution. "These results are strikingly positive and with a large potential impact to patients," Dr. José Baselga said in a speech at the conference discussing the results.
Baselga, the physician in chief at the Memorial Sloan-Kettering Cancer Center, also said the results might have been biased because the study investigators, who determined whether tumors had progressed, knew which patients were getting palbociclib.
Dr. Eric P. Winer, chief of women's cancers at the Dana-Farber Cancer Institute in Boston, says larger studies were still needed.
"This is a small Phase 2 trial - not tiny, but not the kind of study that would typically lead to a change in practice," he said.
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