US oncologists got a letter from @TakedaPharma on 2 RCTs of ixazomib maintenance in myeloma noting a decrease in overall survival in this setting
As a lead investigator of one of the RCTs, my thoughts.
1) Decrease in survival seen post conventional treatment not post transplant
As a lead investigator of one of the RCTs, my thoughts.
1) Decrease in survival seen post conventional treatment not post transplant
2) Overall survival benefit is needed in maintenance setting. Which is why we have not recommended ixazomib maintenance so far except in patients who needed oral maintenance therapy but unable to take Lenalidomide for some reason.
3) Ixazomib is not FDA approved for post transplant maintenance. Current data at median follow up of 5 years shows no difference in overall survival as shown in the figure. My recommendation stays the same. Use it only if you need maintenance but cannot give len or bortezomib.
4) Ixazomib is also not FDA approved for maintenance post conventional therapy. As seen in the figure there is a likely decrease in survival with ixazomib in this setting. Mechanism unclear. My recommendation is to not use ixazomib maintenance in this setting.
5) Ixazomib is FDA approved for relapsed myeloma. Not approved for newly diagnosed. Ixazomib therapy has not been associated with any decrease in overall survival in double blind placebo controlled RCTs in newly diagnosed & relapse settings. Thus use in relapse is not affected.
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