63rd ASH Annual Meeting and Exposition
December 11-14, 2021
  • Triplet Combinations of Novel Therapies
  • Targeted Therapies and Novel Therapies

616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Triplet Combinations of Novel Therapies


Patrick K Reville, Hagop Kantarjian, Gautam Borthakur, et al.

CLAD / LDAC + VEN alternating with AZA + VEN is an effective, lower-intensity therapy. It is well tolerated by patients newly diagnosed with AML (≥ 60 years of age). High response rates with encouraging OS and DFS as well as permanent MRD-negative remissions were observed, with comparable efficacy ≥ 70 and <70 years.



Chong Chyn Chua, John Reynolds, Anoop Kumar Enjeti, et al.

MIDO or PRAN plus VEN-LDAC is tolerated by elderly/unfit patients with treatment-naive AML. This risk-stratified approach was accompanied by a Preliminary favorable efficacy compared to previous studies with VEN-LDAC.



Gail J. Roboz, Thomas Pabst, Ahmed Aribi, et al.

Cusatuzumab plus venetoclax and azacitidine in elderly patients with untreated AML were generally well tolerated. The safety profile was similar to that of VEN-AZA, in addition to generally manageable IRRs. The response rates suggest an additive effect of cusatuzumab to the standard treatment. According to the study authors, this therapy has the potential for improved clinical outcomes.



Musa Yilmaz, Muharrem Muftuoglu, Hagop Kantarjian, et al.

According to the study authors, the combination of DAC + VEN + Quiz is active in heavily pretreated and previously FLT3i-exposed (including 68% with previous gilteritinib) R / R FLT3-ITDm patients. The CRc rate was 65 percent and a median overall survival of 7.5 months. The overall survival after one year was 34 percent. Quiz 30mg QDay was established as the RP2D for the triplet. In this triplet, too, RAS / MAPK mutations are associated with primary and secondary resistance. Updated clinical, NGS, and mass cytometry data will be presented in the oral session.



Naval Daver, Marina Konopleva, Abhishek Maiti, et al.

Azacitidine (AZA) with Venetoclax (VEN) plus Magrolimab (Magro) in ND patients is a safe combination therapy and leads to high CR / CRi rates (94%) and CR rates (81%). The majority (82%) were affected by the ELN adverse risk. ANC and platelet recovery were robust. Early-onset anemia should be monitored.



Naval Daver, Ahmed Aribi, Pau Montesinos, et al.

This novel IMGN632 triplet had convincing anti-leukemia activity in R / R-AML patients. The security profile is manageable. Updated data on safety, efficacy, and PK will be presented in the oral session.

616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Targeted Therapies and Novel Therapies


Pau Montesinos, Christian Recher, Susana Vives, et al.

The results of this study significantly demonstrate the clinical benefit of ivosidenib (IVO) + azacitidine (AZA) compared to placebo + AZA in a difficult-to-treat AML population: the combination improved event-free survival, overall survival, and clinical response (CR, CR + CRh, ORR) in these patients with IC-ineligible, newly diagnosed mIDH1-AML. The favorable safety profile of IVO + AZA was consistent with previous studies.



Jorge E. Cortes, Jordi Esteve, Ashish Bajel, et al.

Olutasidenib plus azacitidine induced durable CR/CRh in a subgroup of high-risk patients with mIDH1-AML. The combination was well tolerated. In all cohorts, some of those treated achieved transfusion independence. Further analyzes on safety and efficacy will be presented at the oral session.



Eytan M. Stein, Ibrahim Aldoss, John F. DiPersio, et al.

SNDX-5613 demonstrated an acceptable safety profile. Promising antileukemic activity has been observed in patients with heavily pretreated R / R MLLr and mNPM1 acute leukemia. The pre-established criteria for RP2D were met with two dose levels in each arm.



Eunice S. Wang, Pau Montesinos, Mark D. Minden, et al.

The combination of gilteritinib (GIL) + azacitidine (AZA) achieved significantly higher CRc rates in the absence of new safety signals, but similar OS compared to AZA alone. Patients with ECOG PS 0-1 and high FLT3-ITD allele ratio appeared to have greater benefit with the combination. Strange: the Ctrough values in patients with ND FLT3mut + AML who were not suitable for IIC were 2 times higher than in patients with R/R FLT3mut + AML. The study results confirm the safety, tolerability and activity of the combination compared to AZA.


701 ASH denotes this abstract as clinically relevant

Curtis Lachowiez, Courtney D. DiNardo, Koichi Takahashi, et al.

Induction and consolidation with fludarabine, high-dose cytarabine (Ara-C0), idarubicin and granulocyte colony-stimulating factor (G-CSF) plus venetoclax (FLAG-IDA + VEN) leads to high MRD-negative CRc rates in ND-AML with an expected safety profile. After one year there was a sustained response with favorable results compared to historical cohorts of intensive therapy. With TP53 mutations there were inferior outcomes in comparison to wild-type TP53.



Naval Daver, Kyoo Hyung Lee, Chul Won Jung, et al.

HM43239 is a preclinically effective FLT3 and SYK inhibitor. In the present study, the substance showed a favorable safety profile with only slight undesirable side effects and no redefining dose-limiting toxicity (DLT). At 80 mg, HM43239 shows clinical activity in both FLT3m and FLT3wt-AML. Updated data on response, safety and PK / PD will be presented in the oral session.


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