Dear all,
Just came across a very promising phase II trial interim update from Japan, from Daiichi Sankyo's ongoing G47 Delta trial. It looks like this virotherapy is heading for fast-approval in Japan, after achieving amazing interim results in recurrent GBM:
- 1 yr survival was 92.3% (12/13 patients), vs. around 15% in historical comparisons
- Median PFS (16 people) was 8.6 months; Median OS has not been reached yet (but at least 4 with a 2 year follow-up so far)
While a small population, the results were so strong that the company is seeking to bypass the phase III trial altogether and apply in the near future for manufacturing & marketing of the treatment. Expectation would be to reach conclusion of this process within this year. It would be the first virotherapy treatment on the market.
I did not find anything on it in the English web, but here is the Japanese press release (best us web translate, which works reasonably well):
https://www.amed.go.jp/news/release_20190213.html?fbclid=IwAR3rLbU6z4MYkAoqr9trLuXQNMwKG9eLYRJd7v8YJiK-Urfex3on7zGtRtE
Very good news I believe! Hopefully we can get similar good news this year also from TOCA & DcVax. I really feel like 2019 will finally be a game changer for GBM, finally!
Best,
John
P.S. Does anyone have a view how likely it would be to get this treatment approved outside of Japan given these results?
Just came across a very promising phase II trial interim update from Japan, from Daiichi Sankyo's ongoing G47 Delta trial. It looks like this virotherapy is heading for fast-approval in Japan, after achieving amazing interim results in recurrent GBM:
- 1 yr survival was 92.3% (12/13 patients), vs. around 15% in historical comparisons
- Median PFS (16 people) was 8.6 months; Median OS has not been reached yet (but at least 4 with a 2 year follow-up so far)
While a small population, the results were so strong that the company is seeking to bypass the phase III trial altogether and apply in the near future for manufacturing & marketing of the treatment. Expectation would be to reach conclusion of this process within this year. It would be the first virotherapy treatment on the market.
I did not find anything on it in the English web, but here is the Japanese press release (best us web translate, which works reasonably well):
https://www.amed.go.jp/news/release_20190213.html?fbclid=IwAR3rLbU6z4MYkAoqr9trLuXQNMwKG9eLYRJd7v8YJiK-Urfex3on7zGtRtE
Very good news I believe! Hopefully we can get similar good news this year also from TOCA & DcVax. I really feel like 2019 will finally be a game changer for GBM, finally!
Best,
John
P.S. Does anyone have a view how likely it would be to get this treatment approved outside of Japan given these results?
Certainly to be followed by the community !
ReplyDeleteThis company has other drugs with US-based development programs.
ReplyDeleteA drug called Trastuzumab Deruxtecan (DS-8201) moved fairly quickly from a small trial in Japan toward larger US-based trials.
Did anyone get any updates regarding the Daiichi Sankyo ? I contacted them in Japan but wouldn't give any info.
ReplyDelete