ASH 2024 | Pegfilgrastim improves outcomes of intensive chemotherapy plus venetoclax in newly diagnosed AML

So thanks for having me. I’d like to talk to you a little bit about our analysis of the use of GCSF, not only neupogen or short-acting GCSF, but more importantly, the use of pegfilgrastim with intensive chemotherapy and venetoclax in patients with newly diagnosed AML. We also presented during this meeting the CLIA regimen, which is intensive chemotherapy plus venetoclax in newly diagnosed patients with AML. And we showed there the response rates were in the range of 94% CRc rate with 89% rate of MRD negative CRs. Now the regimen was very intense. It causes quite a bit of myelosuppression and increased infections. So from 2019 to around 2022, we treated patients with CLIA and venetoclax without the regular use of pegfilgrastim. What I mean by that is we didn’t mandate that every person should get pegfilgrastim. After 2022, we decided to actually incorporate pegfilgrastim, which is a long-acting neupogen or non-acting filgrastim into the regimen similar to what we see in the FLAG-IDA regimen. And so it was nice because we have now two groups of patients, those treated with pegfilgrastim as a standard part of the protocol and those who did not receive it, and what we noticed was something very dramatic. With the introduction of pegfilgrastim, we saw significantly improved rates of neutropenic fever, fewer rates of bacteremia, lower rates of infection, lower rates of ICU admission, and a trend towards improved survival with the use of pegfilgrastim in patients receiving CLIA and venetoclax. On top of that, as you would expect, we saw earlier count recovery almost four days earlier in patients who received pegfilgrastim compared to those who did not, and the median ANC at the time of recovery was significantly higher among those patients who had received pegfilgrastim as opposed to those who did not who had both received CLIA plus and venetoclax. So to me, I think this is practice-changing because this now allows us to use these growth factors in patients with CLIA and venetoclax to make it even more safer and allow more patients to receive it in their treatment program. On top of that, we also then analyzed to make sure that there was no differences in response rate or relapse rate or overall survival that was inferior. Indeed, there was no increased rates of relapse, no decreased rates of MRD negativity, and no decreased rate of response with the addition of pegfilgrastim. I think it’s a safe and effective regimen. It’s not a randomized trial, but it’s something that really allows us to move forward.

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