Pfizer's new drug palbociclib clinical phase 3 trial was terminated early
June 05, 2015 Source: New Drugs
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On May 30, researchers said that palbociclib, a new target drug from Pfizer, can inhibit the development of most common women with advanced breast cancer.
The Phase 3 clinical trial was terminated prematurely because the results were well understood and the combination of this drug and the anti-estrogen drug Fulvestrant doubled the time it took for the tumor to stay in the test period.
A patient with advanced breast cancer is hormone receptor-positive and human-epidermal growth factor-negative (HR+/HER2-), which accounts for approximately three-quarters of all breast cancer patients. For this type of female patient, combination therapy can delay the progression of the disease for more than 9 months, while the Fulvestrant single treatment is only 4 months.
The randomized study included 521 women, 79% of whom were postmenopausal women. The findings were reported at the annual meeting of the American Society of Clinical Cancer (ASCO) in Chicago.
"After the initial hormonal therapy did not work for metastatic breast cancer, the next step is traditional chemotherapy. Chemotherapy is usually very effective, but women often have difficulty with their side effects," said Nicholas C. Turner, the lead author of the study. He is a medical cancer consultant at Royal Marsden and a research team at the London Cancer Institute in the UK.
"This relatively simple and easy new drug can delay the time for women to start chemotherapy, which is an exciting new method for female patients."
Palbociclib works by inhibiting a key protein that promotes hormone receptor-positive breast cancer growth.
The researchers said that in comparison to the benefits of premenopausal and postmenopausal women, longer-term studies are needed to find out whether the drug can prolong the survival of female patients.
Don Dizon, an ASCO expert from the Massachusetts General Hospital, commented on the study that combined treatment works equally well in older women, just like young women.
"With only one drug, you can delay the progression of the disease and delay chemotherapy for a few months, which is very important for patients with advanced breast cancer," he said.
The US FDA has quickly approved the use of palbociclib in combination with another drug, letrozole (Femara), which is a late-stage estrogen receptor-positive (ER+), HER2-based female patient with breast cancer who has not received hormone therapy.
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