63rd ASH Annual Meeting and Exposition
December 11-14, 2021
  • Innovative induction regimens in AML: data from real life and clinical trials
  • Current approach to FLT3 mutated AML
  • Updates in treatment for high-risk AML

615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Innovative induction regimens in AML: data from real life and clinical trials

31 ASH denotes this abstract as clinically relevant

Juliette Lambert, Jérôme Lambert, Emilie Lemasle, et al.

Elderly patients with de novo AML at standard risk are unable to benefit from GO first-line instead of idarubicin in combination with cytarabine. With the reduced dosage regimen, GO had significant toxicities in this study. The incidence of recurrence was non-significant higher, and there was a shorter EFS and a shorter OS.

 

32 ASH denotes this abstract as clinically relevant

Justin Grenet, Akriti G Jain, Madelyn Burkart, et al.

The study showed a significant difference in the overall survival (OS) in favor of CPX-351. This was observed both in the overall cohort and in several clinical subgroups. On the other hand, no difference was found in CR + CRi and RFS. The survival benefit in the CPX-351 group is due to higher HSCT rates in patients treated with CPX-351. Without HSCT, there was no difference in CR + CRi, RFS and OS between the treatment groups. Higher HSCT rates in the CPX-351 cohort are probably due to fewer comorbidities in CPX-351-treated patients. Other biases are also possible. Comorbidity analyzes are still pending.

 

33 ASH denotes this abstract as clinically relevant

Christina Rautenberg, Friedrich Stölzel, Christoph Röllig, et al.

CPX-351 is an efficient treatment for high-risk AML patients. This therapy allows Allo-HCT in many patients and gives encouraging outcome results after the transplantation.

 

34

Colin D. Godwin, Megan Othus, Mary-Elizabeth M. Percival, et al.

In adults with newly diagnosed AML / HG-MN, CLAG-M with fractionated dose GO leads to an MRD-negative CR / CRi rate of 75 percent. The 6-month EFS rate is 73 percent.

 

35

Suning Chen, Jundan Xie, Xiaofei Yang, et al.

Venetoclax plus decitabine is an effective, lower-intensity regimen. It is well tolerated by young adults with newly diagnosed ELN adverse-risk AML. It leads to high CR rates, low infection and early death rates.

 

36

Mithun V. Shah, Rakchha Chhetri, Ruchita Dholakia, et al.

In a subset of patients, VEN resulted in remission, including MRD(-) remission. With continued VEN therapy, 83 percent progressed. PFS and OS were short overall. Neither the morphological diagnosis of t-MDS / t-AML nor the proportion of blasts at the start of VEN therapy could influence the result. An earlier start of therapy with VEN gave better results. Using HMA-based therapies and achieving a deeper response also resulted in better outcomes.

615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Current approach to FLT3 mutated AML

691 ASH denotes this abstract as clinically relevant

Naval Daver, Alexander E. Perl, Joseph Maly, et al.

Regardless of prior TKI administration, R / R FLT3 + AML patients achieved a high mCRc and an encouraging mOS. A majority of patients had FLT3 mutation clearance. This resulted in a longer OS. The remission rates were particularly high in patients with NPM1 + +/- DNMT3A co-mutation. In general, encouraging rates of remission have been observed in many genotypes. By changing the dosage of Ven- or Gilt, the frequently occurring cytopenias could be controlled well. The authors will present further data (serial molecular NGS data / updated survival data) in the session.

 

692 ASH denotes this abstract as clinically relevant

Hartmut Döhner, Daniela Weber, Julia Krzykalla, et al.

The addition of midostaurin to intensive therapy results in both younger and older adult patients with AML and FLT3-ITD in a significant improvement in event-free survival and overall survival compared to a historical control cohort.

 

693 ASH denotes this abstract as clinically relevant

Maher Hanoun, Leo Ruhnke, Michael Kramer, et al.

Independent of the ELN risk group, this retrospective analysis did not find a significant advantage of high-dose cytarabine compared to the intermediate dosage in the consolidation for AML patients under 65 years of age.

 

694 ASH denotes this abstract as clinically relevant

Abhishek Maiti, Courtney D. DiNardo, Caitlin R. Rausch, et al.

DEC10-VEN resulted in high CR / CRi rates. Negative MRD, favorable OS, and RFS were also observed in several genomic subsets of treatment-naive AML. This also applies to NPM1, FLT3, IDH1/2. There were modest results in patients with these mutations in the salvage setting. Patients with TP53, RUNX1, ASXL1, and K/NRAS had suboptimal results. In contrast, the results with the FLT3 VEN HMA triplet were encouraging, especially for frontline therapy in patients with FLT3mut.

 

695 ASH denotes this abstract as clinically relevant

Jianxiang Wang, Bin Jiang, Jian Li, et al.

The results of the COMMODORE study in patients in Asia validate and confirm the clinical efficacy and safety data from the ADMIRAL study. The benefit of gilteritinib in R / R FLT3mut + AML is significant: it prolonged overall survival and event-free survival compared to salvage chemotherapy (SC) in patients with R / R FLT3mut + AML. The safety and tolerability of gilteritinib compared to SC was favorable.

 

696 ASH denotes this abstract as clinically relevant

Nicholas J. Short, Courtney D. DiNardo, Naval Daver, et al.

Patients with FLT3-mutated AML can benefit from an effective combination of azacitidine, venetoclax, and gilteritinib. Gilteritinib 80 mg daily resulted in a better safety/efficacy profile. This dose will be used for future studies. But be careful: even at this lower dose, myelosuppression is common. This requires a dose reduction of azacitidine and venetoclax. Frontline azacitidine, venetoclax, and gilteritinib result in a 100 percent response rate. No relapses have been observed so far.

615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Updates in treatment for high-risk AML

871 ASH denotes this abstract as clinically relevant

Andrew H. Wei, Hartmut Döhner, Hamid Sayar, et al.

The median OS in QUAZAR AML-001 was unchanged in both therapy arms after an additional follow-up of over 1 year. However, in contrast to the primary analysis, the tails of the Oral-AZA and PBO-OS curves showed a greater separation at later points in time. This suggests a sustained, long-term OS benefit with oral AZA. Long-term survival for QUAZAR AML-001 was associated with moderate risk cytogenetics and NPM1 mutations in AML Dx and the lack of a detectable MRD post-intensive chemotherapy.

 

872 ASH denotes this abstract as clinically relevant

Christian Recher, Christoph Rollig, Emilie Berard, et al.

This study, with a long median follow-up time and a large number of patients, shows: intensive chemotherapy remains the treatment strategy of choice even for AML patients aged 70 and older. Because it leads to better chances of survival compared to HMAs.

 

ASH denotes this abstract as clinically relevant

Hong-hu Zhu, Ya-fang Ma, Suning Chen, et al.

RIF plus retinoic acid as a post-remission treatment for high-risk APL is effective and safe.

 

874 ASH denotes this abstract as clinically relevant

Naveen Pemmaraju, Marina Konopleva, Kendra Sweet, et al.

The study results show effective first-line treatment with TAG for BPDCN in all age cohorts, even in older patients and patients with a significant baseline disease. Thanks to a large number of permanent CRs, over 50 percent of patients could be bridged to HSCT, including older adults and patients with extensive baseline disease. Significant relapse-free survival has been observed in some non-transplant patients with TAG, up to 4 years in one patient. Side effects mainly occurring in cycle 1 were manageable. They were similar in older patients compared to younger patients.

 

875

Prapti Patel, Amy S. Ruppert, Uma Borate, et al.

IVO + AZA Tx resulted in a high CR/CRh/CRi rate in ND patients with IDH1m AML and aged 60 or more. There were no early deaths (60 days). The OS was 100 percent after one year. The compatibility of IVO + AZA is acceptable. No unexpected toxicities were recorded. Differentiation syndrome and QTc prolongation were most common with IVO (only one discontinuation of therapy). IVO + AZA achieved a higher CR/CRh / CRi rate compared to earlier studies with single drugs or more intensive chemotherapy approaches. This indicates a synergistic effect. This overall response rate is comparable to that recently for IVO + AZA in elderly patients with ND IDH1 mutated AML. A global phase 3 evaluation of IVO or placebo plus AZA (NCT03173248) is currently in progress.

 

876 ASH denotes this abstract as clinically relevant

Juliette Lambert, Pierre Peterlin, Cecile Pautas, et al.

The response rate in this study was 63 percent. According to the authors of the study, the GO-based regimen appears to be a valuable bridge-to-transplant option. The safety analysis corresponded to the already known safety profile of GO and chemotherapy.

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