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Results of a Phase II study in Renal Cell Carcinoma (RCC):
Presentation of complete results at joint 15th ECCO and 34th ESMO Multidisciplinary Congress / Confirmation of topline data presented at ASCO 2009
Abstract #7105
Berlin, September 22, 2009 - Bayer Schering Pharma AG, Germany, today announced
results from a Phase II trial of regorafenib (BAY 73-4506), a potent oral
multi-kinase inhibitor, which demonstrated that treatment with regorafenib
resulted in a 31 percent partial response rate and 50 percent stabilization
rate in patients with metastatic renal cell carcinoma (RCC). These data were
presented in an oral session at the joint 15th Congress of the European CanCer
Organisation and 34th Congress of the European Society for Medical Oncology
(ECCO 15 - 34th ESMO). Preliminary results from this study were presented
earlier this year at the 45th American Society of Clinical Oncology (ASCO)
Annual Congress, May 29 - June 2, 2009, Orlando, Florida.
"Bayer is committed to researching and developing potential anti-cancer agents
like regorafenib, which may eventually help physicians and patients manage this
devastating disease," said Kemal Malik, MD, Member of the Board of Management
of Bayer Schering Pharma AG and Head of Global Development. "We look forward to
continuing the comprehensive clinical development program for regorafenib,
which we believe could potentially represent a promising new treatment option
for various tumor types."
At the time of data analysis, 81 percent of patients (n=48) in the trial
experienced disease stabilization or regression. Specifically, 31 percent of
patients (n=15) experienced a confirmed partial response (PR), according to the
Response Evaluation Criteria in Solid Tumors (RECIST), and 50 percent of
patients (n=24) experienced stable disease (SD). The data also showed an
estimated median progression-free survival of 8.3 months at the time of
protocol-defined end of study. Importantly, the time of data analyses, which
occurred on May 31, 2009, was prospectively defined in the protocol as when the
last patient was treated for at least six months. At the time of analysis, 25
patients remained on treatment and 80 percent (12 of 15) of patients who
achieved a PR had an ongoing response. Two additional patients who were
classified as having SD achieved a confirmed PR past the data analysis date,
bringing the total PR to 35 percent (n=17) of patients. Study data continue to
be reviewed.
The most common drug-related adverse events (all grades) were hand-foot skin
reaction (HFSR), fatigue, hypertension, mucositis, diarrhea, alopecia, rash,
voice changes, anorexia, nausea, constipation and vomiting.
"This study suggests encouraging activity of regorafenib as a potential
first-line treatment option for patients with advanced RCC. These results,
coupled with those from Phase I studies in other tumor types, provide rationale
for further testing," said lead investigator Professor Tim Eisen, F.R.C.P.,
PhD, of Addenbrooke's Hospital at the University of Cambridge, UK. "I am
excited about the potential of this compound becoming a potential treatment
option for patients and physicians."
About the Trial
This Phase II, multicenter, open-label, single-arm study of regorafenib
enrolled 49 previously untreated patients with metastatic or unresectable,
predominantly clear-cell RCC. Regorafenib (160 mg) was administered once daily
on a three weeks on/one week off schedule. The primary end point was to
evaluate response rate according to RECIST. The secondary end points included
safety, progression-free survival, duration of response, duration of stable
disease, pharmacokinetics, and biomarker data.
About Regorafenib (BAY 73-4506)
Regorafenib (BAY 73-4506) is a potent oral multi-kinase inhibitor with a kinase
inhibition profile targeting angiogenic, stromal and oncogenic receptor
tyrosine kinases (TK). The distinct anti-angiogenic profile includes inhibition
of both VEGFR2 and TIE2 TK. Regorafenib has also been shown in preclinical
studies to prevent the proliferation of tumor cell lines while promoting
apoptosis (cell death) by directly targeting several oncogenic TK receptors.
The clinical significance of these studies is not known and warrant further
investigation in a broad spectrum of tumors.
About Bayer Schering Pharma
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary
of Bayer AG, is one of the world's leading, innovative companies in the
healthcare and medical products industry and is based in Leverkusen, Germany.
The company combines the global activities of the Animal Health, Bayer Schering
Pharma, Consumer Care and Medical Care divisions. Bayer HealthCare's aim is to
discover and manufacture products that will improve human and animal health
worldwide. Find more information at www.bayerhealthcare.com.
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company.
Its research and business activities are focused on the following areas:
Diagnostic Imaging, General Medicine, Specialty Medicine and Women's
Healthcare. With innovative products, Bayer Schering Pharma aims for leading
positions in specialized markets worldwide. Using new ideas, Bayer Schering
Pharma aims to make a contribution to medical progress and strives to improve
the quality of life. Find more information at www.bayerscheringpharma.de.
Details on the studies and the abstract #7105 can be found on the ECCO 15 -
34th ESMO website:
http://www.ecco-org.eu/Conferences-and-Events/ECCO-15/page.aspx/216
