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\Two Drugs Show Promise in Slowing Breast Cancer
Pfizer, Lilly Treatments Stop Tumors From Growing About Twice as Long as Current Therapies
April 6, 2014 10:47 a.m. ET
Two drugs from
Pfizer Inc.
PFE -2.99%
and
Eli Lilly
LLY -0.66%
& Co. that employ a new therapeutic approach showed promise
in slowing the course of breast cancer, according to early-stage
research released on Sunday.
The drug
from Pfizer, taken in a 165-patient study together with a therapy
currently available, stopped tumors from growing for a median of more
than 20 months—about twice as long as the current treatment alone,
researchers said. Meantime, Lilly's drug showed antitumor activity in 33
of 47 patients.
The experimental
therapies target certain proteins in the body known as CDKs. Cancer
hijacks these proteins to help tumor cells grow. The new results show
that stopping these proteins can help stall cancer, according to the
researchers reporting at the American Association for Cancer Research
meeting in San Diego.
Pharmaceutical
companies have had an eye on such an approach for several years, but
early drug-development efforts were felled by side effects such as lower
white-blood cell counts. Researchers believe they've overcome that
problem by targeting two specific proteins, known as CDK 4 and 6, with
the drugs, not the whole class of proteins they belong to.
If
the approach pans out, the drugs could be a new weapon against breast
cancer and potentially other cancers. This class of drugs could stop the
disease in its tracks, and another therapy could then be used to get
rid of the cancer, said
Kelly Hunt,
chief of surgical breast oncology at MD Anderson Cancer Center in
Houston.
"What we're working toward is
getting rid of the chemotherapy part of treatment," said Dr. Hunt, who
is studying the drugs in sarcoma patients but isn't connected with the
breast-cancer studies.
Both the Pfizer and Lilly drugs targeted patients diagnosed with a type of breast cancer known as hormone receptor positive.
Pfizer's
pill, called palbociclib, was studied in a subset of these
metastatic-breast-cancer patients classified as estrogen receptor
positive. The study subjects took Pfizer's pill together with a common
treatment sold under the brand name Femara.
Patients
taking the palbociclib combination lived 37.5 months, compared with
33.3 months taking Femara alone, though it is too early in the trial to
reach statistical significance, according to Pfizer.
Dennis Slamon
and
Richard Finn,
cancer researchers at the University of California, Los Angeles,
who led the study of Pfizer's pill, said they saw some side effects like
lower counts of infection-fighting white blood cells but the
complications were manageable. Dr. Finn said the study's outcome
"validates" the potential of this new class of drugs for certain
breast-cancer patients.
Pfizer has been
talking with the U.S. Food and Drug Administration about using the
middle-stage, or phase 2, study to seek an accelerated approval of the
drug, said
Mace Rothenberg,
a senior vice president who heads cancer clinical development at
Pfizer. Typically, the agency seeks a larger-scale study.
Lilly's
drug, called bemaciclib, was studied in a set of 47
metastatic-breast-cancer patients who had been previously treated.
Tumors decreased in size in nine of the patients participating in the
phase 1 study, while the cancer neither grew nor shrunk much in another
24. patients.
In the 36 Lilly study
subjects with a breast cancer known as hormone receptor positive, tumors
stopped growing for a median of 9.1 months, in line with current
treatment. Nevertheless, a Lilly spokeswoman described the results as
"encouraging" and said "the data support the need for further
development in metastatic breast cancer."
Novartis AG
NOVN.VX -1.21%
is also developing one of these drugs, but the data the company
released at the cancer meeting was only from testing in animals. A
spokeswoman said Novartis is enrolling subjects in a phase 3 study to
test its experimental drug.
Breast
cancer is the most common cancer among women. About 207,000 women in the
U.S. were diagnosed with breast cancer and 41,000 died in 2010,
according to the most recent data from the Centers for Disease Control
and Prevention.
Write to Jonathan D. Rockoff at jonathan.rockoff@wsj.com and Ron Winslow at ron.winslow@wsj.com
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