Encouraging Interim Results on BAY 43-9006 in Advanced Kidney Cancer Presented at American Society of Clinical Oncology (ASCO) M
05 June 2004 - 11:45PM
PR Newswire (US)
Encouraging Interim Results on BAY 43-9006 in Advanced Kidney
Cancer Presented at American Society of Clinical Oncology (ASCO)
Meeting Data Show Durable Responses in Addition to Tumor Shrinkage
and Disease Stabilization NEW ORLEANS, June 5
/PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation
(NYSE:BAY) and Onyx Pharmaceuticals, Inc. (NASDAQ:ONXX) today
announced encouraging new interim results from a Phase II clinical
trial of BAY 43-9006 used as a single agent in patients with
advanced renal cell carcinoma (RCC), or kidney cancer. The results
were presented at the annual meeting of the American Society of
Clinical Oncology in New Orleans. BAY 43-9006, a novel RAF kinase
and VEGFR inhibitor under investigation for the prevention of tumor
growth, combines two anticancer activities: inhibition of tumor
cell proliferation and tumor angiogenesis. "In this study, the use
of BAY 43-9006 in patients with renal cell carcinoma has resulted
in a high level of durable disease stabilization or tumor
shrinkage," said lead investigator Mark Ratain, M.D., Professor of
Medicine and Associate Director for Clinical Sciences, Cancer
Research Center, University of Chicago, USA. "As we continue to
evaluate BAY 43-9006, I am excited about the potential it may offer
in the fight against this form of kidney cancer." The data included
tumor response for 89 participants (of 106 total RCC patients) who
were assessed at 12 weeks, as well as duration of response data for
37 of these participants who experienced tumor shrinkage of greater
than 25 percent. Thirteen of the participants had their tumors
shrink by at least 50 percent at the 12-week assessment. Nine
patients were confirmed to have this degree of tumor response by
subsequent scans conducted at least six weeks later. Thirty-eight
participants had disease stabilization and were randomized. The
remaining 31 (of 106) participants had disease progression or were
discontinued from the study for other reasons. The entire group of
37 patients who had tumor shrinkage, and continued to receive BAY
43-9006 in the open-label phase of the study, had an estimated
median time to tumor progression (TTP) of 48 weeks based on
investigator assessment. Of these, 88 percent were progression free
at six months. These investigator-reported data, including the
confirmatory radiology scans needed to define response rates, are
subject to a final independent radiologic review, which will be
completed by the sponsor at the conclusion of the study. Over 85
percent of the study participants with RCC had tumors that
progressed despite at least one prior systemic treatment, and all
patients had progressive disease on study entry. The RCC
participants were part of a larger study population consisting of
484 treated patients with advanced refractory solid tumors of
multiple types. Safety data were collected for all tumor types. In
the study, the most commonly reported drug-related events include
mild-to-moderate hand-foot syndrome, rash, diarrhea, and
hypertension, which were shown to be manageable and reversible.
"The analysis of the RCC patient experience in this Phase II study
is expected to be complete in the second half of the year," said
Susan Kelley, M.D., vice president, Oncology, Bayer Pharmaceuticals
Corporation. "We remain encouraged by these early findings, and are
very pleased that enrollment in the ongoing worldwide Phase III RCC
study is proceeding well, with virtually all trial sites open and
actively accepting patients." Phase II Study Design The BAY 43-9006
Phase II multi-center, randomized discontinuation trial, which
enrolled more than 200 RCC patients, uses a study design that
consists of two stages: a 12-week induction phase followed by a
randomization phase and a parallel BAY 43-9006 open-label phase.
During the first stage, all study participants received BAY 43-9006
orally at 400 mg twice a day. Subsequently, those patients whose
tumor burden was within 25 percent of their pretreatment
measurements were randomized to either BAY 43-9006 or placebo for
another 12 weeks of treatment. At its conclusion, the codes will be
broken on the randomized patients to evaluate possible evidence of
the compound's contribution to the disease stabilization of these
patients. Additionally, those patients who had tumor shrinkage of
more than 25 percent at the week 12 evaluation continued to be
treated with open-label BAY 43-9006 after the initial 12-week
stage. Patients who had tumor growth of 25 percent or more were
discontinued from the study. About BAY 43-9006 BAY 43-9006, a novel
investigational drug candidate, demonstrated both
anti-proliferative and anti-angiogenic properties - two important
anticancer activities. In preclinical models, BAY 43-9006 inhibited
tumor cell proliferation by targeting the RAF/MEK/ERK signaling
pathway at the level of RAF kinase. BAY 43-9006 also exerted an
antiangiogenic effect by targeting the receptor tyrosine kinases
VEGFR-2 and PDGFR and their associated signaling cascades. For more
information on BAY 43-9006 clinical trials, visit
http://www.clinicaltrials.gov/ Additional BAY 43-9006 ASCO Data
Additional BAY 43-9006 data being presented at this year's ASCO
meeting include: * Phase I/II trial of BAY 43-9006, carboplatin (C)
and paclitaxel (P) demonstrates preliminary antitumor activity in
the expansion cohort of patients with metastatic melanoma. Keith T.
Flaherty, MD. Abstract #7507 (Oral Presentation) * BAY 43-9006 in
patients with advanced melanoma: The Royal Marsden experience.
Tanya Ahmad, MRCP. Abstract #7506 (Oral Presentation) * A phase
I/II trial of BAY 43-9006 and gemcitabine in advanced solid tumors
and in advanced pancreatic cancer. Lillian L. Siu, MD. Abstract
#3059 (Poster #M9) * Results of a phase I trial of BAY 43-9006 in
combination with doxorubicin in patients with refractory solid
tumors. Heike Richly, MD. Abstract #3049 (Poster #L10) * A
randomized phase I clinical and biologic study of two schedules of
BAY 43-9006 in patients with myelodysplastic syndrome (MDS) or
acute myeloid leukemia (AML): A National Cancer Institute of Cancer
Clinical Trials Group Study. Michael Crump, MD. Abstract #6611
(Poster # L11) * Pharmacodynamic study of the RAF kinase inhibitor
BAY 43-9006: Mechanisms of hypertension. Maria Luisa Veronese, MD.
Abstract #2035 (Poster #25) * Results of a phase I trial of BAY
43-9006 in combination with oxaliplatin in patients with refractory
solid tumors. Petra Kupsch, MD. Abstract #3056 (Poster #M6) Kidney
Cancer Renal cell carcinoma is the most common form of kidney
cancer. Nearly 190,000 people worldwide are diagnosed (about 31,000
Americans) with renal cell carcinoma each year, and more than
91,000 of them die (about 12,000 Americans) from the disease
annually.(1) For more information on renal cell carcinoma, visit
the Kidney Cancer Association (KCA) web site at:
http://www.kidneycancerassociation.org/. About Onyx
Pharmaceuticals, Inc. Onyx Pharmaceuticals, Inc. is engaged in the
development of novel cancer therapies that target the molecular
basis of cancer. With its collaborators, the company is developing
small molecule drugs, including BAY 43-9006 with Bayer
Pharmaceuticals Corporation. For more information about Onyx's
pipeline and activities, visit the company's web site at:
http://www.onyx-pharm.com/. About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com/) is
part of the worldwide operations of Bayer HealthCare AG, a subgroup
of Bayer AG. Bayer HealthCare, with sales of approximately 8.9
billion Euro in 2003, is one of the world's leading, innovative
companies in the health care and medical products industry. The
company combines the global activities of the divisions Animal
Health, Biological Products, Consumer Care, Diagnostics and
Pharmaceuticals. About 34,600 people are employed by Bayer
HealthCare worldwide. Our aim is to discover and manufacture
innovative products that will improve human and animal health
worldwide. Our products enhance well being and quality of life by
diagnosing, preventing and treating disease. Forward Looking
Statements This news release contains forward-looking statements
based on current assumptions and forecasts made by Bayer Group
management. Various known and unknown risks, uncertainties and
other factors could lead to material differences between the actual
future results, financial situation, development or performance of
the company and the estimates given here. These factors include
those discussed in Bayer's public reports filed with the Frankfurt
Stock Exchange and with the U.S. Securities and Exchange Commission
(including its Form 20-F). Bayer assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments. This news release also contains
"forward-looking statements" of Onyx within the meaning of the
federal securities laws. These forward-looking statements include
without limitation, statements regarding the timing, progress and
results of the clinical development, regulatory processes and
commercialization efforts of BAY43-9006. These statements are
subject to risks and uncertainties that could cause actual results
and events to differ materially from those anticipated. Reference
should be made Onyx's Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 15, 2004 under the
heading "Additional Business Risks" for a more detailed description
of such factors. Readers are cautioned not to place undue reliance
on these forward-looking statements that speak only as of the date
of this release. Onyx undertakes no obligation to update publicly
any forward-looking statements to reflect new information, events
or circumstances after the date of this release except as required
by law. (1) http://www.who.org/ DATASOURCE: Bayer Pharmaceuticals
Corporation; Onyx Pharmaceuticals, Inc. CONTACT: Mark Bennett of
Bayer Pharmaceuticals Corporation, +1-203-812-2160, or
+1-203-314-5556 (onsite at ASCO), or Helmut Schaefers of Bayer
HealthCare Communications, +49-214-30-58308; or Julie Wood of Onyx
Pharmaceuticals, Inc., +1-510-262-8757, or +1-925-247-4330 (onsite
at ASCO); or Eileen Crowley of GCI Group, +1-212-537-8116, or
+1-646-732-6855 (onsite at ASCO) Web site:
http://www.clinicaltrials.gov/
http://www.kidneycancerassociation.org/ http://www.onyx-pharm.com/
http://www.bayerpharma.com/
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