Avastin三期臨床試驗C-08失敗

羅氏控股的明星藥癌思停(Avastin)在一項為期6個月的三期臨床試驗中顯示將癌思停與化療併用並不能較單獨使用化療更有效治療早期大腸癌。羅式控股股價單日跌幅達11%，創下1990年以來單日最大跌幅。原先預期若C-08的試驗成功，將為羅氏的癌思停增加約40%~50%的銷售量，此項失敗亦使市場認為羅氏先前購併Genentech的價格可能太高。

 

相關報導：

Bloomberg: Roche’s Avastin Misses Goal in Colon-Cancer Study; Shares Slump
WSJ: Does Avastin Trial Mean Roche Paid Too Much for Genentech?

Phase III C-08 study of Avastin in early-stage colon cancer does not meet primary endpoint
Roche and Genentech remain committed to Avastin adjuvant programs

Roche today announced the results of the first phase III trial evaluating the use of Avastin (bevacizumab) plus chemotherapy (FOLFOX) for the treatment of colon cancer immediately following surgery (adjuvant therapy) compared to chemotherapy alone. The study, known as NSABP C-08, did not meet its primary endpoint of lowering the risk of the cancer returning (disease-free survival). This is the first trial of Avastin in early-stage cancer and results do not affect approved indications in advanced (metastatic) disease.

Safety findings were consistent with those presented from this study at the 2008 American Society of Clinical Oncology (ASCO) annual meeting (Allegra et al.)

"While we are disappointed the C-08 study did not meet its primary endpoint, our initial review of the data leads us to continue to believe Avastin may be active in patients with early-stage colon cancer and look forward to NSABP's presentation at ASCO," said Hal Barron, M.D., senior vice president, Development and chief medical officer, Genentech. "We remain fully committed to the ongoing Avastin adjuvant programs in early-stage colon, breast and lung cancers."

"In order to provide patients with the full potential benefit of Avastin in early-stage cancer, we believe the findings of the C-08 trial should be considered for the ongoing adjuvant trial programs," said William M. Burns, CEO of Roche's Pharmaceuticals Division. "The current studies and indications in advanced disease are not affected."

Data from the trial have been submitted for presentation at the upcoming ASCO annual meeting, May 29 - June 2, 2009.

About the NSABP C-08 Trial
This trial was initiated based on the improvement in overall survival observed in metastatic colorectal cancer patients treated with Avastin plus chemotherapy and positive results from two other adjuvant colon cancer studies (MOSAIC and NSABP C-07) with an oxaliplatin containing regimen.

C-08, a phase III randomised, multi-centre study designed to measure disease-free survival as primary endpoint in patients with resected stage II or III adenocarcinoma of the colon, is conducted by the NSABP and sponsored by the National Cancer Institute (NCI). Patients enrolled in the study were randomised to receive treatment with adjuvant Avastin [5 mg/kg intravenous every two weeks for six months] in combination with mFOLFOX6 (5-fluorouracil, leucovorin and oxaliplatin) chemotherapy, followed by Avastin alone every two weeks for an additional six months, or chemotherapy alone for six months. Overall survival is the secondary endpoint of the study.