The safety and efficacy of Kepivance
have not been established in patients with non-haematologic
malignancies, a company release said.
"Until now, severe painful
oral mucositis has been considered an unmet medical need for which no
effective therapies existed to reduce either its incidence or duration.
The most we could do for our patients was to give them ice chips and
narcotics to try and manage their pain," said Patrick Stiff, M.D.,
director of the Cardinal Bernardin Cancer Center, Loyola University
Health System and professor of Hematology/Oncology, Loyola University
Chicago Stritch School of Medicine, Maywood, Ill., and one of the lead
investigators in the Kepivance pivotal trial. "We are excited to have a
new option that will enable physicians to focus on helping to protect
their patients with haematologic malignancies from this complication
rather than solely managing its consequences."
"As a
science-based, patient-focused organization, Amgen works to discover
and develop innovative therapies to treat grievous illnesses," said
Roger M Perlmutter, M.D., Ph.D., executive vice president of research
and development at Amgen. "We are excited that Kepivance is now
available to transplant patients with haematologic malignancies who
suffer from severe oral mucositis. We are also investigating the safety
and efficacy of Kepivance in other cancer treatment modalities."
In
patients with oral mucositis, the cells lining the mouth and throat are
damaged by the chemotherapy drugs and/or radiation used in cancer
treatment. Oral mucositis can be extremely painful and can have a
devastating impact on patients. Severe mouth sores can make patients'
everyday activities, such as eating, drinking, swallowing and talking,
difficult or impossible. Patients suffering from these debilitating
mouth sores may require longer hospitalization, high doses of narcotics
such as morphine, and intravenous feeding to receive nutrition and
maintain hydration.
Approximately 11,000 adult Americans with
haematologic malignancies, including non-Hodgkins lymphoma, Hodgkin's
disease, leukemia and multiple myeloma undergo bone marrow
transplantation each year. Bone marrow transplantation is a procedure
in which a patient's bone marrow is destroyed by anticancer drugs or
radiation and is then replaced. Bone marrow transplants make it
possible to use more effective, very high doses of chemotherapy that
would otherwise be impossible, and nearly all patients undergoing this
treatment suffer from oral mucositis. In fact, oral mucositis is rated
as the most debilitating side effect by patients undergoing this cancer
treatment.
The pivotal phase 3 double-blind study published in
this week's New England Journal of Medicine, compared Kepivance with
placebo in the development of oral mucositis in patients with
haematologic malignancies. Participants were randomized to receive
Kepivance 60 micro-g/kg/day (n=106) or placebo (n=106) intravenously
for three consecutive days immediately before conditioning therapy
(fractionated total body radiation plus high-dose chemotherapy). Then
all patients received bone marrow transplantation, followed by an
additional three days of either Kepivance or placebo.
The
incidence of the most debilitating grade of mucositis (grade 4) was
three times less with Kepivance (20 per cent versus 62 per cent with
placebo), and the incidence of grade 3-4 mucositis where patients can
only swallow liquids, if anything, was reduced by approximately
one-third (63 per cent versus 98 per cent with placebo). Kepivance
reduced the duration of painful oral mucositis (grades 2-4) by almost
half or approximately one week (8 days versus 14 days with placebo).
The
study found that patients treated with Kepivance reported significantly
less mouth and throat soreness, as well as improvements in their
ability to eat, drink, swallow and talk. In addition, patients
receiving Kepivance required fewer days of morphine for their pain than
patients receiving placebo (7 days versus 11 days, respectively).
Kepivance
was shown to be safe and well-tolerated in this study. Adverse events
seen in the study, such as rash, pruritus (itching), erythema (redness
of the skin), paresthesia (tingling skin), mouth/tongue disorders and
taste alterations were mild-to-moderate and transient.
Kepivance
is a recombinant human keratinocyte growth factor that works at the
cellular level to help protect patients with haematologic malignancies
undergoing high-dose chemotherapy and/or radiation followed by bone
marrow transplant from severe oral mucositis. Kepivance reduces the
incidence and duration of severe oral mucositis in these patients by
protecting the epithelial cells that line the mouth and throat from the
damage caused by chemotherapy and radiation and by stimulating the
growth and development of new epithelial cells to build up the mucosal
barrier.
The most common serious adverse reaction in clinical
trials attributed to Kepivance was skin rash reported in less than 1per
cent of patients. Other serious adverse reactions occurred at a similar
rate in patients who received Kepivance or placebo. The most frequently
reported serious adverse event in Kepivance and placebo-treated
patients were fever, gastrointestinal events, and respiratory events.
The most commonly reported adverse reactions were rash, erythema,
edema, pruritus, dysesthesia, mouth/tongue thickness/discoloration, and
taste alteration.
Source: http://www.pharmabiz.com/article/detnews.asp?articleid=25285
