UPDATE 1-Amgen drug cuts prostate cancer bone problems

* Denosumab significantly delays bone risk vs Zometa

* Zometa trial shows anti-cancer benefit in myeloma
(Adds Zometa data)

By Deena Beasley

CHICAGO, June 5 (BestGrowthStock) – A third pivotal trial of Amgen
Inc’s (AMGN.O: ) denosumab found that it significantly delayed
the likelihood of suffering fractures and other bone
complications in men with advanced prostate cancer compared
with current therapy.

The 1,900-patient trial, which compared denosumab with
Novartis AG’s (NOVN.VX: ) Zometa, showed that the Amgen drug
delayed by 3.6 months patients’ first skeletal event, such as a
fracture or the need for bone surgery.

A different Phase III trial of Zometa showed that it
improved survival and significantly reduced the risk of
bone-related problems in patients with newly diagnosed multiple
myeloma, a type of blood cancer, compared to another drug in
its class.

Denosumab, widely considered the most important growth
driver in Amgen’s development pipeline, is the first in a new
class of drugs designed to inhibit proteins that activate
bone-destroying cells.

Zometa is a bisphosphonate that is the current standard of
care for treating cancer patients whose disease has spread to
the bone.

Amgen has said its drug is unlikely to cause the kind of
kidney toxicity associated with the bisphosphonate, and it
believes that the fact that denosumab is given by injection,
rather than an intravenous infusion, is an advantage.


Amgen filed last month for U.S. Food and Drug
Administration approval of denosumab as a treatment for cancer
patients. Earlier this week, the agency approved it, under the
brand name Prolia, for use in post-menopausal women suffering
from osteoporosis.

Roy Baynes, head of hematology/oncology development at
Amgen, said the latest trial results, presented here at a
meeting of the American Society of Clinical Oncology, are
“remarkably consistent” with previous trials in patients with
advanced breast cancer, other solid tumors and multiple

The trial found no difference between the two groups in
overall survival or the amount of time patients lived without
their cancer getting worse.

Baynes said the rates of adverse events, including
infections, were similar between the two treatment groups, but
the incidence of low blood calcium levels was more frequent in
the denosumab arm.

Osteonecrosis of the jaw — death of jaw bone tissue — was
seen in 22 patients receiving denosumab, compared with 12
patients receiving Zometa. Baynes said encouraging information
about those patients will be detailed at the oral presentation
of the study here on Sunday.

Amgen expects to announce in the second half of this year
results from a pivotal trial looking at whether use of
denosumab in patients with earlier-stage prostate cancer can
prevent the disease from spreading to the bones.

“We believe we have a molecule that has a very favorable
profile,” Baynes said.

The consensus analyst forecast is for denosumab to reach
about $3.3 billion in sales in 2014, according to Thomson
Reuters data.

The Novartis trial showed that adding Zometa, also known as
zoledronic acid, to chemotherapy improved overall survival for
multiple myeloma patients by 16 percent compared with oral
clodronate, an older bisphosphonate, plus chemotherapy.

The study also showed that Zometa reduced the relative risk
of bone problems 24 percent more than clodronate.

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(Editing by Xavier Briand)

UPDATE 1-Amgen drug cuts prostate cancer bone problems