Key clinical point: Presence of SRSF2 mutations in patients with acute myeloid leukemia (AML) did not affect clinical outcomes after allogeneic hematopoietic stem cell transplantation (HSCT).

Major finding: Overall, 12.5% of patients harbored an SRSF2 mutation that persisted in 93% of analyzed patients in remission prior to HSCT. SRSF2 P95 mutation at diagnosis and HSCT did not affect the cumulative incidence of relapse (both P = .68), event-free survival (P = .40 and P = .80, respectively), or overall survival (P = .10 and P = .90, respectively) in patients with AML consolidated with HSCT in complete remission (CR) or CR with incomplete peripheral recovery.

Study details: Findings are from a retrospective analysis of 263 adult patients with AML who underwent allogeneic HSCT between May 2000 and August 2020.

Disclosures: This work was supported by the Deutsche José-Carreras-Stiftung, Deutsche Gesellschaft für Innere Medizin, Verein zusammen gegen den Krebs e.V., and Ein Herz für Kinder e.V. The authors declared no conflict of interests.

Source: Grimm J et al. Am J Hematol. 2021 Jul 21. doi: 10.1002/ajh.26298.

Key clinical point: Presence of SRSF2 mutations in patients with acute myeloid leukemia (AML) did not affect clinical outcomes after allogeneic hematopoietic stem cell transplantation (HSCT).

Major finding: Overall, 12.5% of patients harbored an SRSF2 mutation that persisted in 93% of analyzed patients in remission prior to HSCT. SRSF2 P95 mutation at diagnosis and HSCT did not affect the cumulative incidence of relapse (both P = .68), event-free survival (P = .40 and P = .80, respectively), or overall survival (P = .10 and P = .90, respectively) in patients with AML consolidated with HSCT in complete remission (CR) or CR with incomplete peripheral recovery.

Study details: Findings are from a retrospective analysis of 263 adult patients with AML who underwent allogeneic HSCT between May 2000 and August 2020.

Disclosures: This work was supported by the Deutsche José-Carreras-Stiftung, Deutsche Gesellschaft für Innere Medizin, Verein zusammen gegen den Krebs e.V., and Ein Herz für Kinder e.V. The authors declared no conflict of interests.

Source: Grimm J et al. Am J Hematol. 2021 Jul 21. doi: 10.1002/ajh.26298.

Key clinical point: Presence of SRSF2 mutations in patients with acute myeloid leukemia (AML) did not affect clinical outcomes after allogeneic hematopoietic stem cell transplantation (HSCT).

Major finding: Overall, 12.5% of patients harbored an SRSF2 mutation that persisted in 93% of analyzed patients in remission prior to HSCT. SRSF2 P95 mutation at diagnosis and HSCT did not affect the cumulative incidence of relapse (both P = .68), event-free survival (P = .40 and P = .80, respectively), or overall survival (P = .10 and P = .90, respectively) in patients with AML consolidated with HSCT in complete remission (CR) or CR with incomplete peripheral recovery.

Study details: Findings are from a retrospective analysis of 263 adult patients with AML who underwent allogeneic HSCT between May 2000 and August 2020.

Disclosures: This work was supported by the Deutsche José-Carreras-Stiftung, Deutsche Gesellschaft für Innere Medizin, Verein zusammen gegen den Krebs e.V., and Ein Herz für Kinder e.V. The authors declared no conflict of interests.

Source: Grimm J et al. Am J Hematol. 2021 Jul 21. doi: 10.1002/ajh.26298.

Key clinical point: New tumor protein 53 (TP53) mutations could be acquired during acute myeloid leukemia (AML) treatment, particularly after intensive chemotherapy and hematopoietic stem cell transplantation (HSCT), in a proportion of patients with TP53 wild-type AML. Thus, sequential monitoring for emergent TP53 mutations during AML therapy may have clinical relevance.

Major finding: Overall, 15% of patients developed a newly detectable TP53 mutation during AML therapy, with a median variant allele frequency of 15%. Newly detected TP53 mutations were frequent in patients receiving intensive vs low-intensity chemotherapy (23% vs 10%; P = .02) and those who underwent HSCT vs those who did not (36% vs 12%; P = .005).

Study details: Findings are from a retrospective analysis of 200 adult patients with newly diagnosed TP53 wild-type AML who relapsed after or were refractory to frontline therapy.

Disclosures: This study was supported by MD Anderson Cancer Center Support Grant and SPORE. The authors declared no conflict of interests.

Source: Alwash Y et al. Am J Hematol. 2021 Aug 5. doi: 10.1002/ajh.26314.

Key clinical point: New tumor protein 53 (TP53) mutations could be acquired during acute myeloid leukemia (AML) treatment, particularly after intensive chemotherapy and hematopoietic stem cell transplantation (HSCT), in a proportion of patients with TP53 wild-type AML. Thus, sequential monitoring for emergent TP53 mutations during AML therapy may have clinical relevance.

Major finding: Overall, 15% of patients developed a newly detectable TP53 mutation during AML therapy, with a median variant allele frequency of 15%. Newly detected TP53 mutations were frequent in patients receiving intensive vs low-intensity chemotherapy (23% vs 10%; P = .02) and those who underwent HSCT vs those who did not (36% vs 12%; P = .005).

Study details: Findings are from a retrospective analysis of 200 adult patients with newly diagnosed TP53 wild-type AML who relapsed after or were refractory to frontline therapy.

Disclosures: This study was supported by MD Anderson Cancer Center Support Grant and SPORE. The authors declared no conflict of interests.

Source: Alwash Y et al. Am J Hematol. 2021 Aug 5. doi: 10.1002/ajh.26314.

Key clinical point: New tumor protein 53 (TP53) mutations could be acquired during acute myeloid leukemia (AML) treatment, particularly after intensive chemotherapy and hematopoietic stem cell transplantation (HSCT), in a proportion of patients with TP53 wild-type AML. Thus, sequential monitoring for emergent TP53 mutations during AML therapy may have clinical relevance.

Major finding: Overall, 15% of patients developed a newly detectable TP53 mutation during AML therapy, with a median variant allele frequency of 15%. Newly detected TP53 mutations were frequent in patients receiving intensive vs low-intensity chemotherapy (23% vs 10%; P = .02) and those who underwent HSCT vs those who did not (36% vs 12%; P = .005).

Study details: Findings are from a retrospective analysis of 200 adult patients with newly diagnosed TP53 wild-type AML who relapsed after or were refractory to frontline therapy.

Disclosures: This study was supported by MD Anderson Cancer Center Support Grant and SPORE. The authors declared no conflict of interests.

Source: Alwash Y et al. Am J Hematol. 2021 Aug 5. doi: 10.1002/ajh.26314.

Key clinical point: Among patients with core binding factor (CBF)-acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (allo-HCT) in complete remission (CR), pretransplant measurable residual disease (MRD) predicts posttransplant outcomes differently in patients with t(8;21) and those with inv(16).

Major finding: Pretransplant MRD negativity was associated with lower relapse (hazard ratio [HR], 0.46; P less than .001), overall mortality (HR, 0.72; P = .037), and treatment failure (HR, 0.66; P = .004) among patients with t(8;21) AML but not those with inv(16) AML (all P > .05).

Study details: Findings are from a retrospective analysis of 959 patients with CBF-AML with either t(8;21) AML (n=631) or inv(16) AML (n=328) who underwent first allo-HCT in CR between 2000 and 2018.

Disclosures: This work was supported partly by the Practical Research Project for Allergic Diseases and Immunology from the Japan Agency for Medical Research and Development. The authors declared no conflict of interests.

Source: Konuma T et al. Bone Marrow Transplant. 2021 Jul 16. doi: 10.1038/s41409-021-01409-4.

Key clinical point: Among patients with core binding factor (CBF)-acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (allo-HCT) in complete remission (CR), pretransplant measurable residual disease (MRD) predicts posttransplant outcomes differently in patients with t(8;21) and those with inv(16).

Major finding: Pretransplant MRD negativity was associated with lower relapse (hazard ratio [HR], 0.46; P less than .001), overall mortality (HR, 0.72; P = .037), and treatment failure (HR, 0.66; P = .004) among patients with t(8;21) AML but not those with inv(16) AML (all P > .05).

Study details: Findings are from a retrospective analysis of 959 patients with CBF-AML with either t(8;21) AML (n=631) or inv(16) AML (n=328) who underwent first allo-HCT in CR between 2000 and 2018.

Disclosures: This work was supported partly by the Practical Research Project for Allergic Diseases and Immunology from the Japan Agency for Medical Research and Development. The authors declared no conflict of interests.

Source: Konuma T et al. Bone Marrow Transplant. 2021 Jul 16. doi: 10.1038/s41409-021-01409-4.

Key clinical point: Among patients with core binding factor (CBF)-acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (allo-HCT) in complete remission (CR), pretransplant measurable residual disease (MRD) predicts posttransplant outcomes differently in patients with t(8;21) and those with inv(16).

Major finding: Pretransplant MRD negativity was associated with lower relapse (hazard ratio [HR], 0.46; P less than .001), overall mortality (HR, 0.72; P = .037), and treatment failure (HR, 0.66; P = .004) among patients with t(8;21) AML but not those with inv(16) AML (all P > .05).

Study details: Findings are from a retrospective analysis of 959 patients with CBF-AML with either t(8;21) AML (n=631) or inv(16) AML (n=328) who underwent first allo-HCT in CR between 2000 and 2018.

Disclosures: This work was supported partly by the Practical Research Project for Allergic Diseases and Immunology from the Japan Agency for Medical Research and Development. The authors declared no conflict of interests.

Source: Konuma T et al. Bone Marrow Transplant. 2021 Jul 16. doi: 10.1038/s41409-021-01409-4.

Key clinical point: Fluid overload (FO) associated with increased administration of crystalloid fluids affected survival in patients with acute myeloid leukemia (AML) undergoing induction chemotherapy. Weight-adjusted prescription of crystalloid fluids may reduce the risk for FO in this patient population.

Major finding: FO was observed in 12.3% of patients with AML. Patients receiving more than 100 mL crystalloid fluids/kg body weight were at a higher risk for FO (odds ratio, 2.78; P = .033). Patients with FO had inferior 90-day survival vs those without FO (P = .0044).

Study details: Findings are from a retrospective analysis of 187 adult patients with AML receiving induction chemotherapy between 2014 and 2019.

Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.

Source: Ballo O et al. Ann Hematol. 2021 Jul 25. doi: 10.1007/s00277-021-04593-x.

Key clinical point: Fluid overload (FO) associated with increased administration of crystalloid fluids affected survival in patients with acute myeloid leukemia (AML) undergoing induction chemotherapy. Weight-adjusted prescription of crystalloid fluids may reduce the risk for FO in this patient population.

Major finding: FO was observed in 12.3% of patients with AML. Patients receiving more than 100 mL crystalloid fluids/kg body weight were at a higher risk for FO (odds ratio, 2.78; P = .033). Patients with FO had inferior 90-day survival vs those without FO (P = .0044).

Study details: Findings are from a retrospective analysis of 187 adult patients with AML receiving induction chemotherapy between 2014 and 2019.

Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.

Source: Ballo O et al. Ann Hematol. 2021 Jul 25. doi: 10.1007/s00277-021-04593-x.

Key clinical point: Fluid overload (FO) associated with increased administration of crystalloid fluids affected survival in patients with acute myeloid leukemia (AML) undergoing induction chemotherapy. Weight-adjusted prescription of crystalloid fluids may reduce the risk for FO in this patient population.

Major finding: FO was observed in 12.3% of patients with AML. Patients receiving more than 100 mL crystalloid fluids/kg body weight were at a higher risk for FO (odds ratio, 2.78; P = .033). Patients with FO had inferior 90-day survival vs those without FO (P = .0044).

Study details: Findings are from a retrospective analysis of 187 adult patients with AML receiving induction chemotherapy between 2014 and 2019.

Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.

Source: Ballo O et al. Ann Hematol. 2021 Jul 25. doi: 10.1007/s00277-021-04593-x.

Key clinical point: Among patients with relapsed acute myeloid leukemia (AML) following allogeneic stem cell transplant (allo-SCT), high-intensity chemotherapy followed by cell therapy (CT), such as second allo-SCT or donor lymphocyte infusion (DLI), led to improved survival vs other treatment options.

Major finding: Overall survival at 1 year was significantly higher in patients receiving high-intensity chemotherapy prior to CT (52.9%) vs high-intensity chemotherapy alone (10%), low-intensity chemotherapy alone (5%), and low-intensity chemotherapy followed by CT (23.1%; P <  .001).

Study details: Findings are from a retrospective analysis of 69 patients with AML who relapsed following allo-SCT between January 2014 and August 2019 (n=172). Relapsed patients received either second allo-SCT (n=4), DLI (n=26), chemotherapy alone (n=31), or no treatment (n=8).

Disclosures: No specific source of funding was identified. The authors declared no conflict of interests.

Source: Shah N et al. Ann Hematol. 2021 Jul 29. doi: 10.1007/s00277-021-04616-7.

Key clinical point: Among patients with relapsed acute myeloid leukemia (AML) following allogeneic stem cell transplant (allo-SCT), high-intensity chemotherapy followed by cell therapy (CT), such as second allo-SCT or donor lymphocyte infusion (DLI), led to improved survival vs other treatment options.

Major finding: Overall survival at 1 year was significantly higher in patients receiving high-intensity chemotherapy prior to CT (52.9%) vs high-intensity chemotherapy alone (10%), low-intensity chemotherapy alone (5%), and low-intensity chemotherapy followed by CT (23.1%; P <  .001).

Study details: Findings are from a retrospective analysis of 69 patients with AML who relapsed following allo-SCT between January 2014 and August 2019 (n=172). Relapsed patients received either second allo-SCT (n=4), DLI (n=26), chemotherapy alone (n=31), or no treatment (n=8).

Disclosures: No specific source of funding was identified. The authors declared no conflict of interests.

Source: Shah N et al. Ann Hematol. 2021 Jul 29. doi: 10.1007/s00277-021-04616-7.

Key clinical point: Among patients with relapsed acute myeloid leukemia (AML) following allogeneic stem cell transplant (allo-SCT), high-intensity chemotherapy followed by cell therapy (CT), such as second allo-SCT or donor lymphocyte infusion (DLI), led to improved survival vs other treatment options.

Major finding: Overall survival at 1 year was significantly higher in patients receiving high-intensity chemotherapy prior to CT (52.9%) vs high-intensity chemotherapy alone (10%), low-intensity chemotherapy alone (5%), and low-intensity chemotherapy followed by CT (23.1%; P <  .001).

Study details: Findings are from a retrospective analysis of 69 patients with AML who relapsed following allo-SCT between January 2014 and August 2019 (n=172). Relapsed patients received either second allo-SCT (n=4), DLI (n=26), chemotherapy alone (n=31), or no treatment (n=8).

Disclosures: No specific source of funding was identified. The authors declared no conflict of interests.

Source: Shah N et al. Ann Hematol. 2021 Jul 29. doi: 10.1007/s00277-021-04616-7.

Key clinical point: Induction chemotherapy (IC) with intermediate-dosed cytarabine (ID-AraC) followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) was an effective treatment strategy in patients with secondary or treatment-related acute myeloid leukemia (AML).

Major finding: The median overall survival (OS) and event-free survival of the whole cohort were 15 (range, 0-234) months and 11 (range, 0-234) months, respectively. Complete remission (CR)/CR with incomplete hematologic recovery was achieved in 62.7% of patients receiving ID-AraC. Patients who underwent allo-HSCT after IC showed better OS vs those without allo-HSCT (46 months vs 9 months; P less than .0001).

Study details: Findings are from a retrospective analysis of 110 patients with secondary (AML following myelodysplastic syndrome [n=65], chronic myelomonocytic leukemia [n=15], or myeloproliferative syndrome [n=7]) or treatment-related (n=23) AML. Patients were treated with IC consisting of ID-AraC in combination with either idarubicin or mitoxantrone.

Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.

Source: Fleischmann M et al. J Cancer Res Clin Oncol. 2021 Jul 23. doi: 10.1007/s00432-021-03733-0.

Key clinical point: Induction chemotherapy (IC) with intermediate-dosed cytarabine (ID-AraC) followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) was an effective treatment strategy in patients with secondary or treatment-related acute myeloid leukemia (AML).

Major finding: The median overall survival (OS) and event-free survival of the whole cohort were 15 (range, 0-234) months and 11 (range, 0-234) months, respectively. Complete remission (CR)/CR with incomplete hematologic recovery was achieved in 62.7% of patients receiving ID-AraC. Patients who underwent allo-HSCT after IC showed better OS vs those without allo-HSCT (46 months vs 9 months; P less than .0001).

Study details: Findings are from a retrospective analysis of 110 patients with secondary (AML following myelodysplastic syndrome [n=65], chronic myelomonocytic leukemia [n=15], or myeloproliferative syndrome [n=7]) or treatment-related (n=23) AML. Patients were treated with IC consisting of ID-AraC in combination with either idarubicin or mitoxantrone.

Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.

Source: Fleischmann M et al. J Cancer Res Clin Oncol. 2021 Jul 23. doi: 10.1007/s00432-021-03733-0.

Key clinical point: Induction chemotherapy (IC) with intermediate-dosed cytarabine (ID-AraC) followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) was an effective treatment strategy in patients with secondary or treatment-related acute myeloid leukemia (AML).

Major finding: The median overall survival (OS) and event-free survival of the whole cohort were 15 (range, 0-234) months and 11 (range, 0-234) months, respectively. Complete remission (CR)/CR with incomplete hematologic recovery was achieved in 62.7% of patients receiving ID-AraC. Patients who underwent allo-HSCT after IC showed better OS vs those without allo-HSCT (46 months vs 9 months; P less than .0001).

Study details: Findings are from a retrospective analysis of 110 patients with secondary (AML following myelodysplastic syndrome [n=65], chronic myelomonocytic leukemia [n=15], or myeloproliferative syndrome [n=7]) or treatment-related (n=23) AML. Patients were treated with IC consisting of ID-AraC in combination with either idarubicin or mitoxantrone.

Disclosures: Open Access funding was enabled and organized by Projekt DEAL. The authors declared no conflict of interests.

Source: Fleischmann M et al. J Cancer Res Clin Oncol. 2021 Jul 23. doi: 10.1007/s00432-021-03733-0.

Key clinical point: Ten-day regimen of decitabine with venetoclax (DEC10-VEN) may represent a potential option for salvage therapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), offering superior responses and survival vs intensive chemotherapy (IC)-based regimens.

Major finding: Patients receiving DEC10-VEN vs IC had superior overall response rate (odds ratio [OR], 3.28; P < .001), minimal residual disease negativity (OR, 2.48; P = .017), event-free survival (hazard ratio [HR], 0.46; P < .001), and overall survival (HR, 0.56; P = .008). Rates of refractory disease (OR, 0.46; P = .011) and 60-day mortality (OR, 0.40; P = .029) were significantly lower in patients receiving DEC10-VEN vs IC.

Study details: This retrospective study assessed outcomes of adult patients with R/R AML treated with DEC10-VEN (n=65) in a phase 2 trial vs IC-based regimens (n=130) using propensity score-matched analysis.

Disclosures: This study was supported by grants from the National Cancer Institute and National Institutes of Health. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Maiti A et al. Cancer. 2021 Aug 3. doi: 10.1002/cncr.33814.

Key clinical point: Ten-day regimen of decitabine with venetoclax (DEC10-VEN) may represent a potential option for salvage therapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), offering superior responses and survival vs intensive chemotherapy (IC)-based regimens.

Major finding: Patients receiving DEC10-VEN vs IC had superior overall response rate (odds ratio [OR], 3.28; P < .001), minimal residual disease negativity (OR, 2.48; P = .017), event-free survival (hazard ratio [HR], 0.46; P < .001), and overall survival (HR, 0.56; P = .008). Rates of refractory disease (OR, 0.46; P = .011) and 60-day mortality (OR, 0.40; P = .029) were significantly lower in patients receiving DEC10-VEN vs IC.

Study details: This retrospective study assessed outcomes of adult patients with R/R AML treated with DEC10-VEN (n=65) in a phase 2 trial vs IC-based regimens (n=130) using propensity score-matched analysis.

Disclosures: This study was supported by grants from the National Cancer Institute and National Institutes of Health. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Maiti A et al. Cancer. 2021 Aug 3. doi: 10.1002/cncr.33814.

Key clinical point: Ten-day regimen of decitabine with venetoclax (DEC10-VEN) may represent a potential option for salvage therapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML), offering superior responses and survival vs intensive chemotherapy (IC)-based regimens.

Major finding: Patients receiving DEC10-VEN vs IC had superior overall response rate (odds ratio [OR], 3.28; P < .001), minimal residual disease negativity (OR, 2.48; P = .017), event-free survival (hazard ratio [HR], 0.46; P < .001), and overall survival (HR, 0.56; P = .008). Rates of refractory disease (OR, 0.46; P = .011) and 60-day mortality (OR, 0.40; P = .029) were significantly lower in patients receiving DEC10-VEN vs IC.

Study details: This retrospective study assessed outcomes of adult patients with R/R AML treated with DEC10-VEN (n=65) in a phase 2 trial vs IC-based regimens (n=130) using propensity score-matched analysis.

Disclosures: This study was supported by grants from the National Cancer Institute and National Institutes of Health. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Maiti A et al. Cancer. 2021 Aug 3. doi: 10.1002/cncr.33814.

Key clinical point: Patients with TP53-mutated acute myeloid leukemia (AML) receiving a 10-day regimen of decitabine with venetoclax (DEC10-VEN) experienced inferior response rates and survival vs those with wild-type TP53 AML.

Major finding: Patients with TP53-mutant vs wild-type TP53 AML had significantly lower overall survival (hazard ratio [HR], 4.67; P < .0001), relapse-free survival (HR, 4.80; P < .001), overall response rate (66% vs 89%; P = .002), and complete response (CR)/CR with incomplete hematologic recovery rate (57% vs 77%; P = .029).

Study details: Findings are from a post hoc analysis of a phase 2 trial including 118 patients with newly diagnosed AML unfit for intensive chemotherapy or with secondary or relapsed/refractory AML receiving frontline therapy with DEC10-VEN. Overall, 35 patients had TP53-mutated AML.

Disclosures: This study was supported by grants from the National Cancer Institute and the National Institutes of Health. Some investigators reported ties with various pharmaceutical companies.

Source: Kim K et al. Cancer. 2021 Jul 13. doi: 10.1002/cncr.33689.

Key clinical point: Patients with TP53-mutated acute myeloid leukemia (AML) receiving a 10-day regimen of decitabine with venetoclax (DEC10-VEN) experienced inferior response rates and survival vs those with wild-type TP53 AML.

Major finding: Patients with TP53-mutant vs wild-type TP53 AML had significantly lower overall survival (hazard ratio [HR], 4.67; P < .0001), relapse-free survival (HR, 4.80; P < .001), overall response rate (66% vs 89%; P = .002), and complete response (CR)/CR with incomplete hematologic recovery rate (57% vs 77%; P = .029).

Study details: Findings are from a post hoc analysis of a phase 2 trial including 118 patients with newly diagnosed AML unfit for intensive chemotherapy or with secondary or relapsed/refractory AML receiving frontline therapy with DEC10-VEN. Overall, 35 patients had TP53-mutated AML.

Disclosures: This study was supported by grants from the National Cancer Institute and the National Institutes of Health. Some investigators reported ties with various pharmaceutical companies.

Source: Kim K et al. Cancer. 2021 Jul 13. doi: 10.1002/cncr.33689.

Key clinical point: Patients with TP53-mutated acute myeloid leukemia (AML) receiving a 10-day regimen of decitabine with venetoclax (DEC10-VEN) experienced inferior response rates and survival vs those with wild-type TP53 AML.

Major finding: Patients with TP53-mutant vs wild-type TP53 AML had significantly lower overall survival (hazard ratio [HR], 4.67; P < .0001), relapse-free survival (HR, 4.80; P < .001), overall response rate (66% vs 89%; P = .002), and complete response (CR)/CR with incomplete hematologic recovery rate (57% vs 77%; P = .029).

Study details: Findings are from a post hoc analysis of a phase 2 trial including 118 patients with newly diagnosed AML unfit for intensive chemotherapy or with secondary or relapsed/refractory AML receiving frontline therapy with DEC10-VEN. Overall, 35 patients had TP53-mutated AML.

Disclosures: This study was supported by grants from the National Cancer Institute and the National Institutes of Health. Some investigators reported ties with various pharmaceutical companies.

Source: Kim K et al. Cancer. 2021 Jul 13. doi: 10.1002/cncr.33689.

Key clinical point: Addition of oblimersen sodium (G3139) to standard chemotherapy did not improve clinical outcomes vs standard chemotherapy alone in previously untreated older patients with acute myeloid leukemia (AML).

Major finding: No statistically significant differences were observed in complete remission rates (P = .53), median overall survival (1-sided log-rank P = .13), median event-free survival (P = .80), median disease-free survival (P = .26), and early death rates (P = .81) in the G3139 vs standard chemotherapy arm. No added toxicities were observed with G3139 vs standard chemotherapy alone.

Study details: Findings are from phase 3 Cancer and Leukemia Group B 10201 trial including 506 untreated patients with AML aged at least 60 years. Patients were randomly assigned to receive standard intensive cytarabine/daunorubicin induction chemotherapy and high-dose cytarabine consolidation with (n=254) or without (n=252) G3139.

Disclosures: This work was supported by the National Cancer Institute, National Institutes of Health, and Deltec Inc. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Walker AR et al. Blood Adv. 2021 Jul 12. doi: 10.1182/bloodadvances.2021004233.

Key clinical point: Addition of oblimersen sodium (G3139) to standard chemotherapy did not improve clinical outcomes vs standard chemotherapy alone in previously untreated older patients with acute myeloid leukemia (AML).

Major finding: No statistically significant differences were observed in complete remission rates (P = .53), median overall survival (1-sided log-rank P = .13), median event-free survival (P = .80), median disease-free survival (P = .26), and early death rates (P = .81) in the G3139 vs standard chemotherapy arm. No added toxicities were observed with G3139 vs standard chemotherapy alone.

Study details: Findings are from phase 3 Cancer and Leukemia Group B 10201 trial including 506 untreated patients with AML aged at least 60 years. Patients were randomly assigned to receive standard intensive cytarabine/daunorubicin induction chemotherapy and high-dose cytarabine consolidation with (n=254) or without (n=252) G3139.

Disclosures: This work was supported by the National Cancer Institute, National Institutes of Health, and Deltec Inc. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Walker AR et al. Blood Adv. 2021 Jul 12. doi: 10.1182/bloodadvances.2021004233.

Key clinical point: Addition of oblimersen sodium (G3139) to standard chemotherapy did not improve clinical outcomes vs standard chemotherapy alone in previously untreated older patients with acute myeloid leukemia (AML).

Major finding: No statistically significant differences were observed in complete remission rates (P = .53), median overall survival (1-sided log-rank P = .13), median event-free survival (P = .80), median disease-free survival (P = .26), and early death rates (P = .81) in the G3139 vs standard chemotherapy arm. No added toxicities were observed with G3139 vs standard chemotherapy alone.

Study details: Findings are from phase 3 Cancer and Leukemia Group B 10201 trial including 506 untreated patients with AML aged at least 60 years. Patients were randomly assigned to receive standard intensive cytarabine/daunorubicin induction chemotherapy and high-dose cytarabine consolidation with (n=254) or without (n=252) G3139.

Disclosures: This work was supported by the National Cancer Institute, National Institutes of Health, and Deltec Inc. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Walker AR et al. Blood Adv. 2021 Jul 12. doi: 10.1182/bloodadvances.2021004233.

Key clinical point: Addition of venetoclax to intensive chemotherapy with cladribine, idarubicin, and high-dose cytarabine (CLIA regimen) was safe and feasible as frontline therapy in patients aged 65 years or younger with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Major finding: Overall, 94% (95% confidence interval [CI], 83%-98%) had a composite complete response and 82% (95% CI, 68%-92%) achieved measurable residual disease negativity. At 12 months, the rates of duration of response, overall survival, and event-free survival were 74% (95% CI, 60%-92%), 85% (95% CI, 75%-97%), and 68% (95% CI, 54%-85%), respectively. The most common grade 3 or worse adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%).

Study details: Findings are from a cohort study from the phase 2 CLIA trial including 50 patients (age, 18-65 years) with newly diagnosed AML (90%), MDS (8%), or mixed phenotype acute leukemia (2%).

Disclosures: This study was supported by grants from the MD Anderson Cancer Center. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Kadia TM et al. Lancet Haematol. 2021 Aug 1. doi: 10.1016/S2352-3026(21)00192-7.

Key clinical point: Addition of venetoclax to intensive chemotherapy with cladribine, idarubicin, and high-dose cytarabine (CLIA regimen) was safe and feasible as frontline therapy in patients aged 65 years or younger with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Major finding: Overall, 94% (95% confidence interval [CI], 83%-98%) had a composite complete response and 82% (95% CI, 68%-92%) achieved measurable residual disease negativity. At 12 months, the rates of duration of response, overall survival, and event-free survival were 74% (95% CI, 60%-92%), 85% (95% CI, 75%-97%), and 68% (95% CI, 54%-85%), respectively. The most common grade 3 or worse adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%).

Study details: Findings are from a cohort study from the phase 2 CLIA trial including 50 patients (age, 18-65 years) with newly diagnosed AML (90%), MDS (8%), or mixed phenotype acute leukemia (2%).

Disclosures: This study was supported by grants from the MD Anderson Cancer Center. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Kadia TM et al. Lancet Haematol. 2021 Aug 1. doi: 10.1016/S2352-3026(21)00192-7.

Key clinical point: Addition of venetoclax to intensive chemotherapy with cladribine, idarubicin, and high-dose cytarabine (CLIA regimen) was safe and feasible as frontline therapy in patients aged 65 years or younger with newly diagnosed acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Major finding: Overall, 94% (95% confidence interval [CI], 83%-98%) had a composite complete response and 82% (95% CI, 68%-92%) achieved measurable residual disease negativity. At 12 months, the rates of duration of response, overall survival, and event-free survival were 74% (95% CI, 60%-92%), 85% (95% CI, 75%-97%), and 68% (95% CI, 54%-85%), respectively. The most common grade 3 or worse adverse events were febrile neutropenia (84%), infection (12%), and alanine aminotransferase elevations (12%).

Study details: Findings are from a cohort study from the phase 2 CLIA trial including 50 patients (age, 18-65 years) with newly diagnosed AML (90%), MDS (8%), or mixed phenotype acute leukemia (2%).

Disclosures: This study was supported by grants from the MD Anderson Cancer Center. Some investigators including the lead author reported ties with various pharmaceutical companies.

Source: Kadia TM et al. Lancet Haematol. 2021 Aug 1. doi: 10.1016/S2352-3026(21)00192-7.