Encouraging data for open label extension sub-group, but where are data for randomization sub-group?
Miljenko
PS: IMO, Their mistake is single agent PIII. They should run combination against standard.
Encouraging Interim Results on BAY 43-9006 in Advanced Kidney Cancer Presented at American Society of Clinical Oncology (ASCO) Meeting
Saturday June 5, 8:45 am ET
Data Show Durable Responses in Addition to Tumor Shrinkage and Disease Stabilization
NEW ORLEANS, June 5 /PRNewswire-FirstCall/ -- Bayer Pharmaceuticals Corporation (NYSE: BAY - News) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX - News) 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.
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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. |
