Petition updateFDA Accept Actinium Pharmaceuticals Iomab-B BLA Application for Approval Considerationdurable complete remission and morphologic leukemia-free state (MLFS)
Ray .NY, United States
29 Oct 2024

https://ascopubs.org/doi/pdfdirect/10.1200/JCO.23.02018

https://ascopubs.org/action/downloadSupplement?doi=10.1200%2FJCO.23.02018&file=DS_JCO.23.02018.pdf

"The protocol specified that conventional care patients who achieved CR/CRp could undergo alloHCT, but nine of 14 transplanted patients in the conventional care group underwent alloHCT following MLFS to improve their outcomes. Two of these patients had ≥6-month remission, of whom one remained alive and in remission at the final data cutoff. These patients were not adjudicated as having a dCR because they had not achieved CR/CRp after salvage treatment. Had they been adjudicated as having dCR, the difference between treatment groups would still be statistically significant (17.1% v 2.6%; P = .0026)."

Discussion: With studies showing that non-CR patients can have positive survival outcomes (e.g. MLFS before HCT), the SIERRA study still showed a survival improvement over this patient population. It just goes to show that Iomab-B survival outcomes, despite a patient population that statistically had a 6% HCT prognostic outcome (according to the Duval score), benefitted from this conditioning treatment prior to HCT.

 

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