Bayer HealthCare AG and Onyx Pharmaceuticals, Inc.
today announced that the companies have begun enrolling patients in an
international Phase III trial to evaluate Nexavar® (sorafenib) tablets in
patients with non-squamous non-small cell lung cancer (NSCLC) who have
failed two or three previous treatments.
"Nexavar has proven efficacy in kidney cancer and liver cancer and we are
committed to researching Nexavar in a variety of other solid tumors," said
Dimitris Voliotis, MD, vice president, Nexavar Clinical Development, Bayer
HealthCare. "Based on strong findings in the Phase II trials, Bayer and
Onyx moved to the next phase of development and initiated this Phase III
trial evaluating Nexavar in NSCLC."
About the Phase III Study
The MISSION (Monotherapy administration of Sorafenib in patients with
non-small cell lung cancer) trial is an international multicenter study
that will enroll approximately 850 patients with advanced relapsed or
refractory non-squamous cell NSCLC who have failed two or three previous
treatments. Patients will be randomized to receive either Nexavar as single
agent or placebo. In both treatment arms, best supportive care will be
provided. The primary endpoint of this trial is overall survival, and
secondary endpoints include progression-free survival and overall response
rate. The safety and tolerability of the two treatment groups will also be
compared.
The study will be conducted at more than 120 sites in North America, South
America, Europe, Africa and the Asia-Pacific region, including Japan. For
information about this study, please visit clinicaltrials.
"As the leading cause of cancer deaths worldwide, lung cancer is a complex
disease that requires new therapeutic options for patients," said Laura
Brege, executive vice president and chief operating officer at Onyx
Pharmaceuticals. "We are committed to studying Nexavar to understand how it
may play a role in the treatment paradigm of this difficult-to-treat
disease."
About Non-Small Cell Lung Cancer (NSCLC)
NSCLC accounts for 85-90 percent of diagnosed lung cancers and is a disease
in which malignant (cancer) cells form in the tissues of the lung. It is
characterized by several types of lung cancers, each of which grow and
spread in different ways, including: squamous cell carcinoma,
adenocarcinoma, and large cell carcinoma.
Every year 1.4 million people worldwide will be diagnosed with lung cancer
and 1.2 million will die from the disease. Nearly 60 percent of people in
the U.S. diagnosed with lung cancer die within one year of their diagnosis
and 75 percent die within 2 years. These survival rates have not improved
in the past 10 years.
About Nexavar®
Nexavar®, an oral anti-cancer therapy, is currently approved in more than
70 countries for liver cancer and in more than 80 countries for the
treatment of patients with advanced kidney cancer. In Europe, Nexavar is
approved for the treatment of hepatocellular carcinoma and for the
treatment of patients with advanced renal cell carcinoma (RCC) who have
failed prior interferon-alpha or interleukin-2 based therapy or are
considered unsuitable for such therapy.
Nexavar targets both the tumor cell and tumor vasculature. In preclinical
studies, Nexavar has been shown to target members of two classes of kinases
known to be involved in both cell proliferation (growth) and angiogenesis
(blood supply) - two important processes that enable cancer growth. These
kinases included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3
and RET.
Nexavar is also being evaluated by the companies, international study
groups, government agencies and individual investigators as a single agent
or combination treatment in a wide range of other cancers, including breast
cancer, lung cancer, ovarian cancer, colorectal cancer, and as an adjuvant
therapy for kidney cancer and liver cancer.
A science podcast about Sorafenib can be found here:
http//www.podcast.bayer.
Source
Onyx Pharmaceuticals, Bayer Schering Pharma
View drug information on Nexavar.