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Monday, 07/17/2017 2:12:47 PM

Monday, July 17, 2017 2:12:47 PM

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Interesting comment from Cloughesy, who is leading the GLOBE trial, regarding avastin:

“This is the first prospective, randomized clinical trial to address the question of bevacizumab continuation in recurrent glioblastoma,” Dr. Hovey said. “Continuing bevacizumab after progression of recurrent glioblastoma did not improve PFS,” nor did it confer “any apparent clinical benefit.” She said that these results must be placed in context with a variety of other data, but this study suggests that bevacizumab should not routinely be continued beyond disease progression.

Discussant Timothy Cloughesy, MD, of the University of California, Los Angeles, called the data compelling. “We have been evaluating bevacizumab for 10 years, and we don’t have a really clear idea of where we’re going,” he said.
https://am.asco.org/no-benefit-continued-bevacizumab-recurrent-glioblastoma

Also, it looks like avastin achieved some crazy results in early trials that drove the FDA approval. Its median OS of 9.2 months in one phase 2 but subsequent trials have shown mOS to be in the range of 8 months (32 weeks).

Several phase I/II studies reported high responses and improved 6-month progression-free survival with Bevacizumab. Based on these results Bevacizumab, a vascular endothelial growth factor inhibitor received FDA approval for use in recurrent gliomas. Subsequently, a better planned randomized phase 2 BRAIN trial investigated bevacizumab alone and in combination with irinotecan did not show a convincing benefit of Bevacizumab compared with historical series [42]. The trial randomly allocated 167 patients with first or second relapse to receive Bevacizumab monotherapy or in combination with Irinotecan. The primary end points were 6-months PFS and overall response rate. The trial reported 6 months PFS 42.6% and 50.3% in the monotherapy and combination arm, and ORR 28.2% and 37.8% respectively. Median Overall survival was 9.2 months and 8.7 months respectively.
http://www.sciencedirect.com/science/article/pii/S111003621630036X

If VB-111 comes close to its phase 2 results (59 weeks mOS) then it would be an amazing accomplishment.
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