Key clinical point: Elevated serum amylase (ESA) was associated with adverse clinical outcomes and mortality in hospitalized patients with COVID-19.

Major finding: Hyperamylasemia (amylase > upper limit of normal [ULN] of 115 U/L) was independently associated with mortality (1-3-times ULN [1-3 ULN]: hazard ratio [HR] 1.63; P = .034; >3-fold ULN [>3 ULN]: HR 8.90; P < .001) and adverse outcomes (all P < .001), such as sepsis (1-3 ULN: odds ratio [OR] 1.15; >3 ULN: OR 1.87), disseminated intravascular coagulation (1-3 ULN: OR 1.13; >3 ULN: OR 1.65), cardiac injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.71), acute respiratory distress syndrome (1-3 ULN: OR 1.21; >3 ULN: OR 1.62), and acute kidney injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.79).

Study details: This retrospective study included 1,515 inpatients with COVID-19. Overall, 196 patients had ESA, of which 9.7% had an ESA of >3 ULN.

Disclosures: This study was supported by the National Nature Science Foundation of China and Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province. The authors declared no conflict of interests.

Source: Li G et al. Aging (Albany NY). 2021(Oct 29);13(20):23442-23458. Doi: 10.18632/aging.203653.

Key clinical point: Elevated serum amylase (ESA) was associated with adverse clinical outcomes and mortality in hospitalized patients with COVID-19.

Major finding: Hyperamylasemia (amylase > upper limit of normal [ULN] of 115 U/L) was independently associated with mortality (1-3-times ULN [1-3 ULN]: hazard ratio [HR] 1.63; P = .034; >3-fold ULN [>3 ULN]: HR 8.90; P < .001) and adverse outcomes (all P < .001), such as sepsis (1-3 ULN: odds ratio [OR] 1.15; >3 ULN: OR 1.87), disseminated intravascular coagulation (1-3 ULN: OR 1.13; >3 ULN: OR 1.65), cardiac injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.71), acute respiratory distress syndrome (1-3 ULN: OR 1.21; >3 ULN: OR 1.62), and acute kidney injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.79).

Study details: This retrospective study included 1,515 inpatients with COVID-19. Overall, 196 patients had ESA, of which 9.7% had an ESA of >3 ULN.

Disclosures: This study was supported by the National Nature Science Foundation of China and Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province. The authors declared no conflict of interests.

Source: Li G et al. Aging (Albany NY). 2021(Oct 29);13(20):23442-23458. Doi: 10.18632/aging.203653.

Key clinical point: Elevated serum amylase (ESA) was associated with adverse clinical outcomes and mortality in hospitalized patients with COVID-19.

Major finding: Hyperamylasemia (amylase > upper limit of normal [ULN] of 115 U/L) was independently associated with mortality (1-3-times ULN [1-3 ULN]: hazard ratio [HR] 1.63; P = .034; >3-fold ULN [>3 ULN]: HR 8.90; P < .001) and adverse outcomes (all P < .001), such as sepsis (1-3 ULN: odds ratio [OR] 1.15; >3 ULN: OR 1.87), disseminated intravascular coagulation (1-3 ULN: OR 1.13; >3 ULN: OR 1.65), cardiac injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.71), acute respiratory distress syndrome (1-3 ULN: OR 1.21; >3 ULN: OR 1.62), and acute kidney injury (1-3 ULN: OR 1.24; >3 ULN: OR 1.79).

Study details: This retrospective study included 1,515 inpatients with COVID-19. Overall, 196 patients had ESA, of which 9.7% had an ESA of >3 ULN.

Disclosures: This study was supported by the National Nature Science Foundation of China and Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province. The authors declared no conflict of interests.

Source: Li G et al. Aging (Albany NY). 2021(Oct 29);13(20):23442-23458. Doi: 10.18632/aging.203653.

Key clinical point: An increased intrapancreatic fat deposition (IPFD) following acute pancreatitis (AP) was associated with a decrease in pancreatic tail diameter (PTD), and in turn, decreased circulating levels of pancreatic amylase.

Major finding: An increased IPFD was significantly associated with reduced PTD in patients with AP (P = .036). Pancreatic amylase was associated with PTD in AP (P = .042).

Study details: This cross-sectional study included 108 individuals with previous AP (median, 20 months post-AP) and 60 healthy controls.

Disclosures: This study was supported by the Rutherford Discovery Fellowship by the Royal Society of New Zealand to MS Petrov. The authors declared no conflict of interests.

Source: Ko J et al. Obes Facts. 2021(Nov 9). Doi: 10.1159/000519621.

Key clinical point: An increased intrapancreatic fat deposition (IPFD) following acute pancreatitis (AP) was associated with a decrease in pancreatic tail diameter (PTD), and in turn, decreased circulating levels of pancreatic amylase.

Major finding: An increased IPFD was significantly associated with reduced PTD in patients with AP (P = .036). Pancreatic amylase was associated with PTD in AP (P = .042).

Study details: This cross-sectional study included 108 individuals with previous AP (median, 20 months post-AP) and 60 healthy controls.

Disclosures: This study was supported by the Rutherford Discovery Fellowship by the Royal Society of New Zealand to MS Petrov. The authors declared no conflict of interests.

Source: Ko J et al. Obes Facts. 2021(Nov 9). Doi: 10.1159/000519621.

Key clinical point: An increased intrapancreatic fat deposition (IPFD) following acute pancreatitis (AP) was associated with a decrease in pancreatic tail diameter (PTD), and in turn, decreased circulating levels of pancreatic amylase.

Major finding: An increased IPFD was significantly associated with reduced PTD in patients with AP (P = .036). Pancreatic amylase was associated with PTD in AP (P = .042).

Study details: This cross-sectional study included 108 individuals with previous AP (median, 20 months post-AP) and 60 healthy controls.

Disclosures: This study was supported by the Rutherford Discovery Fellowship by the Royal Society of New Zealand to MS Petrov. The authors declared no conflict of interests.

Source: Ko J et al. Obes Facts. 2021(Nov 9). Doi: 10.1159/000519621.

Key clinical point: Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator use was associated with reduced incidence of acute pancreatitis (AP) hospitalizations in pancreas-sufficient (PS) and pancreas-insufficient (PI) patients with CF.

Major finding: Estimated rates of AP hospitalizations per 1000 patient-years in patients with PS-CF and PI-CF treated with CFTR modulator were 3.26 (95% CI 0.94-11.33) and 0.66 (95% CI 0.26-1.68), respectively, and those not treated with CFTR modulator were 10.20 (95% CI 6.19-16.81) and 1.76 (95% CI 0.98-3.17), respectively.

Study details: Findings are from a retrospective analysis of 10,417 patients with CF (PS n = 3,759; PI n = 6,658) with (17.2%) or without previous CFTR modulator use.

Disclosures: This study was supported by the US National Center for Advancing Translational Sciences. The authors declared no conflict of interests.

Source: Ramsey ML et al. Am J Gastroenterol. 2021(Oct 19). Doi: 10.14309/ajg.0000000000001527.

Key clinical point: Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator use was associated with reduced incidence of acute pancreatitis (AP) hospitalizations in pancreas-sufficient (PS) and pancreas-insufficient (PI) patients with CF.

Major finding: Estimated rates of AP hospitalizations per 1000 patient-years in patients with PS-CF and PI-CF treated with CFTR modulator were 3.26 (95% CI 0.94-11.33) and 0.66 (95% CI 0.26-1.68), respectively, and those not treated with CFTR modulator were 10.20 (95% CI 6.19-16.81) and 1.76 (95% CI 0.98-3.17), respectively.

Study details: Findings are from a retrospective analysis of 10,417 patients with CF (PS n = 3,759; PI n = 6,658) with (17.2%) or without previous CFTR modulator use.

Disclosures: This study was supported by the US National Center for Advancing Translational Sciences. The authors declared no conflict of interests.

Source: Ramsey ML et al. Am J Gastroenterol. 2021(Oct 19). Doi: 10.14309/ajg.0000000000001527.

Key clinical point: Cystic fibrosis (CF) transmembrane conductance regulator (CFTR) modulator use was associated with reduced incidence of acute pancreatitis (AP) hospitalizations in pancreas-sufficient (PS) and pancreas-insufficient (PI) patients with CF.

Major finding: Estimated rates of AP hospitalizations per 1000 patient-years in patients with PS-CF and PI-CF treated with CFTR modulator were 3.26 (95% CI 0.94-11.33) and 0.66 (95% CI 0.26-1.68), respectively, and those not treated with CFTR modulator were 10.20 (95% CI 6.19-16.81) and 1.76 (95% CI 0.98-3.17), respectively.

Study details: Findings are from a retrospective analysis of 10,417 patients with CF (PS n = 3,759; PI n = 6,658) with (17.2%) or without previous CFTR modulator use.

Disclosures: This study was supported by the US National Center for Advancing Translational Sciences. The authors declared no conflict of interests.

Source: Ramsey ML et al. Am J Gastroenterol. 2021(Oct 19). Doi: 10.14309/ajg.0000000000001527.

Key clinical point: After 12 months, SARS-CoV-2 infection increased the risk for idiopathic acute pancreatitis (AP) but not of diabetes or exocrine pancreatic insufficiency (EPI).

Major finding: Patients who were SARS-CoV-2 positive vs. negative were at a higher risk of idiopathic AP (34.7% vs. 13.9%; odds ratio [OR] 5.34; P < .001) but not of diabetes (2.3% vs. 2.5%; OR 0.61; P = .541) or EPI (OR 1.11; P = .828).

Study details: Findings are from a 12-month follow-up analysis of 1,476 patients with (n = 118) or without (n = 1,358) SARS-CoV-2 infection.

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

Source: Nayar M et al. Gut. 2021(Nov 11). Doi: 10.1136/gutjnl-2021-326218.

Key clinical point: After 12 months, SARS-CoV-2 infection increased the risk for idiopathic acute pancreatitis (AP) but not of diabetes or exocrine pancreatic insufficiency (EPI).

Major finding: Patients who were SARS-CoV-2 positive vs. negative were at a higher risk of idiopathic AP (34.7% vs. 13.9%; odds ratio [OR] 5.34; P < .001) but not of diabetes (2.3% vs. 2.5%; OR 0.61; P = .541) or EPI (OR 1.11; P = .828).

Study details: Findings are from a 12-month follow-up analysis of 1,476 patients with (n = 118) or without (n = 1,358) SARS-CoV-2 infection.

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

Source: Nayar M et al. Gut. 2021(Nov 11). Doi: 10.1136/gutjnl-2021-326218.

Key clinical point: After 12 months, SARS-CoV-2 infection increased the risk for idiopathic acute pancreatitis (AP) but not of diabetes or exocrine pancreatic insufficiency (EPI).

Major finding: Patients who were SARS-CoV-2 positive vs. negative were at a higher risk of idiopathic AP (34.7% vs. 13.9%; odds ratio [OR] 5.34; P < .001) but not of diabetes (2.3% vs. 2.5%; OR 0.61; P = .541) or EPI (OR 1.11; P = .828).

Study details: Findings are from a 12-month follow-up analysis of 1,476 patients with (n = 118) or without (n = 1,358) SARS-CoV-2 infection.

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

Source: Nayar M et al. Gut. 2021(Nov 11). Doi: 10.1136/gutjnl-2021-326218.

Key clinical point: Maintenance therapy with tipifarnib did not prolong survival in patients with acute myeloid leukemia (AML) in remission.

Major finding: The median disease-free survival for tipifarnib vs. observation arms was 8.9 vs. 5.3 months (hazard ratio [HR] 0.70; P = .026), which did not meet the prespecified limit to call a positive effect. The median overall survival was not significantly different between tipifarnib vs. observation arms (16.4 vs. 9.3 months; HR 0.74; P = .056).

Study details: Findings are from the phase 3 E2902 trial including 144 adult patients with non-M3 AML in remission and who were randomly assigned to tipifarnib or observation arms.

Disclosures: This study was supported by the US National Cancer Institute of the National Institutes of Health. No disclosures were reported.

Source: Luger SM et al. Leuk Res. 2021;111:106736 (Oct 28). Doi: 10.1016/j.leukres.2021.106736.

Key clinical point: Maintenance therapy with tipifarnib did not prolong survival in patients with acute myeloid leukemia (AML) in remission.

Major finding: The median disease-free survival for tipifarnib vs. observation arms was 8.9 vs. 5.3 months (hazard ratio [HR] 0.70; P = .026), which did not meet the prespecified limit to call a positive effect. The median overall survival was not significantly different between tipifarnib vs. observation arms (16.4 vs. 9.3 months; HR 0.74; P = .056).

Study details: Findings are from the phase 3 E2902 trial including 144 adult patients with non-M3 AML in remission and who were randomly assigned to tipifarnib or observation arms.

Disclosures: This study was supported by the US National Cancer Institute of the National Institutes of Health. No disclosures were reported.

Source: Luger SM et al. Leuk Res. 2021;111:106736 (Oct 28). Doi: 10.1016/j.leukres.2021.106736.

Key clinical point: Maintenance therapy with tipifarnib did not prolong survival in patients with acute myeloid leukemia (AML) in remission.

Major finding: The median disease-free survival for tipifarnib vs. observation arms was 8.9 vs. 5.3 months (hazard ratio [HR] 0.70; P = .026), which did not meet the prespecified limit to call a positive effect. The median overall survival was not significantly different between tipifarnib vs. observation arms (16.4 vs. 9.3 months; HR 0.74; P = .056).

Study details: Findings are from the phase 3 E2902 trial including 144 adult patients with non-M3 AML in remission and who were randomly assigned to tipifarnib or observation arms.

Disclosures: This study was supported by the US National Cancer Institute of the National Institutes of Health. No disclosures were reported.

Source: Luger SM et al. Leuk Res. 2021;111:106736 (Oct 28). Doi: 10.1016/j.leukres.2021.106736.

Key clinical point: Alvocidib followed by cytarabine and mitoxantrone (ACM) was clinically active and well tolerated in patients with myeloid cell leukemia-1 (MCL-1)-dependent relapsed/refractory (R/R) acute myeloid leukemia (AML).

Major finding: The rates of composite complete remission after 1 cycle of ACM therapy were 47%, 21%, 64%, and 52% in patients with R/R AML with MCL-1 <15%, 15% to <30%, 30% to <40%, and ≥40%, respectively. The rate of 30-day mortality was 6% in the R/R AML cohort.

Study details: Findings are from the phase 2 Zella-201 study including 221 adult patients with R/R AML and an exploratory cohort of 169 patients with newly diagnosed high-risk AML, of which 39% were MCL-1 dependent (≥40%).

Disclosures: This study was supported by Tolero Pharmaceuticals, acquired by Sumitomo Dainippon Pharma (SDP). Some investigators, including the lead author, reported being employees of; receiving research funding, honoraria, grants, or drug support from; being on advisory boards or data monitoring committees for; or receiving consultancy or speaker roles from various sources, including Tolero and SDP.

Source: Zeidner JF et al. Blood Cancer J. 2021;11:175 (Oct 30). Doi: 10.1038/s41408-021-00568-3.

Key clinical point: Alvocidib followed by cytarabine and mitoxantrone (ACM) was clinically active and well tolerated in patients with myeloid cell leukemia-1 (MCL-1)-dependent relapsed/refractory (R/R) acute myeloid leukemia (AML).

Major finding: The rates of composite complete remission after 1 cycle of ACM therapy were 47%, 21%, 64%, and 52% in patients with R/R AML with MCL-1 <15%, 15% to <30%, 30% to <40%, and ≥40%, respectively. The rate of 30-day mortality was 6% in the R/R AML cohort.

Study details: Findings are from the phase 2 Zella-201 study including 221 adult patients with R/R AML and an exploratory cohort of 169 patients with newly diagnosed high-risk AML, of which 39% were MCL-1 dependent (≥40%).

Disclosures: This study was supported by Tolero Pharmaceuticals, acquired by Sumitomo Dainippon Pharma (SDP). Some investigators, including the lead author, reported being employees of; receiving research funding, honoraria, grants, or drug support from; being on advisory boards or data monitoring committees for; or receiving consultancy or speaker roles from various sources, including Tolero and SDP.

Source: Zeidner JF et al. Blood Cancer J. 2021;11:175 (Oct 30). Doi: 10.1038/s41408-021-00568-3.

Key clinical point: Alvocidib followed by cytarabine and mitoxantrone (ACM) was clinically active and well tolerated in patients with myeloid cell leukemia-1 (MCL-1)-dependent relapsed/refractory (R/R) acute myeloid leukemia (AML).

Major finding: The rates of composite complete remission after 1 cycle of ACM therapy were 47%, 21%, 64%, and 52% in patients with R/R AML with MCL-1 <15%, 15% to <30%, 30% to <40%, and ≥40%, respectively. The rate of 30-day mortality was 6% in the R/R AML cohort.

Study details: Findings are from the phase 2 Zella-201 study including 221 adult patients with R/R AML and an exploratory cohort of 169 patients with newly diagnosed high-risk AML, of which 39% were MCL-1 dependent (≥40%).

Disclosures: This study was supported by Tolero Pharmaceuticals, acquired by Sumitomo Dainippon Pharma (SDP). Some investigators, including the lead author, reported being employees of; receiving research funding, honoraria, grants, or drug support from; being on advisory boards or data monitoring committees for; or receiving consultancy or speaker roles from various sources, including Tolero and SDP.

Source: Zeidner JF et al. Blood Cancer J. 2021;11:175 (Oct 30). Doi: 10.1038/s41408-021-00568-3.

Key clinical point: Intracranial hemorrhage (ICH) is still a deadly complication affecting survival in patients with newly diagnosed nonacute promyelocytic acute myeloid leukemia (AML) receiving intensive induction chemotherapy (IIC) despite routine prophylactic platelet substitution.

Major finding: Overall, 4% of patients developed ICH. Patients with ICH vs. without had worse overall survival (median, 20.1 vs. 104.8 months; P = .0079) with female sex (adjusted odds ratio [aOR] 3.79; P = .03), low thrombocyte (aOR 1.2; P = .03), and fibrinogen levels at admission (aOR 1.62; P = .03) being risk factors for ICH.

Study details: This retrospective study included 423 patients with newly diagnosed nonacute promyelocytic AML hospitalized for IIC with routine platelet transfusions at <10 thrombocytes/nL.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Koschade SE et al. Eur J Haematol. 2021(Oct 29). Doi: 10.1111/ejh.13718.

Key clinical point: Intracranial hemorrhage (ICH) is still a deadly complication affecting survival in patients with newly diagnosed nonacute promyelocytic acute myeloid leukemia (AML) receiving intensive induction chemotherapy (IIC) despite routine prophylactic platelet substitution.

Major finding: Overall, 4% of patients developed ICH. Patients with ICH vs. without had worse overall survival (median, 20.1 vs. 104.8 months; P = .0079) with female sex (adjusted odds ratio [aOR] 3.79; P = .03), low thrombocyte (aOR 1.2; P = .03), and fibrinogen levels at admission (aOR 1.62; P = .03) being risk factors for ICH.

Study details: This retrospective study included 423 patients with newly diagnosed nonacute promyelocytic AML hospitalized for IIC with routine platelet transfusions at <10 thrombocytes/nL.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Koschade SE et al. Eur J Haematol. 2021(Oct 29). Doi: 10.1111/ejh.13718.

Key clinical point: Intracranial hemorrhage (ICH) is still a deadly complication affecting survival in patients with newly diagnosed nonacute promyelocytic acute myeloid leukemia (AML) receiving intensive induction chemotherapy (IIC) despite routine prophylactic platelet substitution.

Major finding: Overall, 4% of patients developed ICH. Patients with ICH vs. without had worse overall survival (median, 20.1 vs. 104.8 months; P = .0079) with female sex (adjusted odds ratio [aOR] 3.79; P = .03), low thrombocyte (aOR 1.2; P = .03), and fibrinogen levels at admission (aOR 1.62; P = .03) being risk factors for ICH.

Study details: This retrospective study included 423 patients with newly diagnosed nonacute promyelocytic AML hospitalized for IIC with routine platelet transfusions at <10 thrombocytes/nL.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Koschade SE et al. Eur J Haematol. 2021(Oct 29). Doi: 10.1111/ejh.13718.

Key clinical point: Antimicrobial prophylaxis significantly reduced rates of bloodstream infection (BSI), invasive fungal infection (IFI), and febrile neutropenia (FN) in pediatric patients with acute myeloid leukemia (AML) receiving chemotherapy.

Major finding: Episodes of BSI (Gram-negative: 5% vs. 12%, P = .002; Gram-positive: 1% vs. 5%; P = .024) and IFI (0% vs. 4%; P = .003) decreased significantly in the prophylaxis vs. preprophylaxis period. FN episodes during induction (78% vs. 99%) and high-dose (64% vs. 94%) or moderate-dose (27% vs. 58%) chemotherapy also reduced in prophylaxis vs. preprophylaxis period (all P < .001).

Study details: This observational study included 90 children with newly diagnosed AML receiving induction and postremission high- or moderate-dose chemotherapy. Antimicrobial prophylaxis administered in 28 patients consisted of ciprofloxacin, voriconazole, and vancomycin.

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

Source: Yeh TC et al. Sci Rep. 2021;11: 21142 (Oct 27). Doi: 10.1038/s41598-021-00725-5.

Key clinical point: Antimicrobial prophylaxis significantly reduced rates of bloodstream infection (BSI), invasive fungal infection (IFI), and febrile neutropenia (FN) in pediatric patients with acute myeloid leukemia (AML) receiving chemotherapy.

Major finding: Episodes of BSI (Gram-negative: 5% vs. 12%, P = .002; Gram-positive: 1% vs. 5%; P = .024) and IFI (0% vs. 4%; P = .003) decreased significantly in the prophylaxis vs. preprophylaxis period. FN episodes during induction (78% vs. 99%) and high-dose (64% vs. 94%) or moderate-dose (27% vs. 58%) chemotherapy also reduced in prophylaxis vs. preprophylaxis period (all P < .001).

Study details: This observational study included 90 children with newly diagnosed AML receiving induction and postremission high- or moderate-dose chemotherapy. Antimicrobial prophylaxis administered in 28 patients consisted of ciprofloxacin, voriconazole, and vancomycin.

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

Source: Yeh TC et al. Sci Rep. 2021;11: 21142 (Oct 27). Doi: 10.1038/s41598-021-00725-5.

Key clinical point: Antimicrobial prophylaxis significantly reduced rates of bloodstream infection (BSI), invasive fungal infection (IFI), and febrile neutropenia (FN) in pediatric patients with acute myeloid leukemia (AML) receiving chemotherapy.

Major finding: Episodes of BSI (Gram-negative: 5% vs. 12%, P = .002; Gram-positive: 1% vs. 5%; P = .024) and IFI (0% vs. 4%; P = .003) decreased significantly in the prophylaxis vs. preprophylaxis period. FN episodes during induction (78% vs. 99%) and high-dose (64% vs. 94%) or moderate-dose (27% vs. 58%) chemotherapy also reduced in prophylaxis vs. preprophylaxis period (all P < .001).

Study details: This observational study included 90 children with newly diagnosed AML receiving induction and postremission high- or moderate-dose chemotherapy. Antimicrobial prophylaxis administered in 28 patients consisted of ciprofloxacin, voriconazole, and vancomycin.

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

Source: Yeh TC et al. Sci Rep. 2021;11: 21142 (Oct 27). Doi: 10.1038/s41598-021-00725-5.

Key clinical point: Wilms’ tumor 1 helper peptide OCV-501 was well tolerated, but did not significantly improve clinical outcomes in elderly patients with acute myeloid leukemia (AML) in first complete remission (CR1). However, immune responders may benefit from OCV-501.

Major finding: The median disease-free survival (P = .7671) and overall survival (P = .8540) were not significantly different between OCV-501 vs. placebo groups. However, those with an immune response to OCV-501 had better survival outcomes (P < .0001). Adverse drug reactions were more frequent in patients receiving OCV-501 vs. placebo (91.2% vs. 58.5%) and were mainly injection-site reactions.

Study details: This phase 2 study included 134 elderly (age ³60 years) patients with AML who achieved CR1 within 1 or 2 courses of standard induction therapies and were randomly assigned to either OCV-501 (n = 69) or placebo (n = 65).

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd (OPCL). K Masui, Y Ihara, M Hirota, and N Shimofurutani reported being employees of OPCL. Some investigators, including the lead author, reported receiving grants and personal fees from various sources including OPCL.

Source: Kiguchi T et al. Cancer Immunol Immunother. 2021(Oct 22). Doi: 10.1007/s00262-021-03074-4.

Key clinical point: Wilms’ tumor 1 helper peptide OCV-501 was well tolerated, but did not significantly improve clinical outcomes in elderly patients with acute myeloid leukemia (AML) in first complete remission (CR1). However, immune responders may benefit from OCV-501.

Major finding: The median disease-free survival (P = .7671) and overall survival (P = .8540) were not significantly different between OCV-501 vs. placebo groups. However, those with an immune response to OCV-501 had better survival outcomes (P < .0001). Adverse drug reactions were more frequent in patients receiving OCV-501 vs. placebo (91.2% vs. 58.5%) and were mainly injection-site reactions.

Study details: This phase 2 study included 134 elderly (age ³60 years) patients with AML who achieved CR1 within 1 or 2 courses of standard induction therapies and were randomly assigned to either OCV-501 (n = 69) or placebo (n = 65).

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd (OPCL). K Masui, Y Ihara, M Hirota, and N Shimofurutani reported being employees of OPCL. Some investigators, including the lead author, reported receiving grants and personal fees from various sources including OPCL.

Source: Kiguchi T et al. Cancer Immunol Immunother. 2021(Oct 22). Doi: 10.1007/s00262-021-03074-4.

Key clinical point: Wilms’ tumor 1 helper peptide OCV-501 was well tolerated, but did not significantly improve clinical outcomes in elderly patients with acute myeloid leukemia (AML) in first complete remission (CR1). However, immune responders may benefit from OCV-501.

Major finding: The median disease-free survival (P = .7671) and overall survival (P = .8540) were not significantly different between OCV-501 vs. placebo groups. However, those with an immune response to OCV-501 had better survival outcomes (P < .0001). Adverse drug reactions were more frequent in patients receiving OCV-501 vs. placebo (91.2% vs. 58.5%) and were mainly injection-site reactions.

Study details: This phase 2 study included 134 elderly (age ³60 years) patients with AML who achieved CR1 within 1 or 2 courses of standard induction therapies and were randomly assigned to either OCV-501 (n = 69) or placebo (n = 65).

Disclosures: This study was funded by Otsuka Pharmaceutical Co., Ltd (OPCL). K Masui, Y Ihara, M Hirota, and N Shimofurutani reported being employees of OPCL. Some investigators, including the lead author, reported receiving grants and personal fees from various sources including OPCL.

Source: Kiguchi T et al. Cancer Immunol Immunother. 2021(Oct 22). Doi: 10.1007/s00262-021-03074-4.

Key clinical point: Optimization of a traditional induction regimen with idarubicin and cytarabine (IA) with additional homoharringtonine according to day 5 peripheral blast clearance rate (D5-PBCR) ³99.55% (D5-PBCR−) is feasible in patients with newly diagnosed acute myeloid leukemia (AML) with reversal of unfavorable outcomes observed in patients with D5-PBCR <99.55% (D5-PBCR+).

Major finding: Rates of composite complete remission after 1 cycle of induction (CR1) were 87.5% and 80.0% in D5-PBCR− and D5-PBCR+ groups, respectively, with CR1 rate improving by almost 18% in the D5-PBCR+ group compared with the historical data (P = .049). The median overall survival, event-free survival, and grade 3 or higher adverse events were similar between the 2 groups.

Study details: Findings are from a phase 2 RJ-AML 2014 trial including 151 adult patients with untreated newly diagnosed AML who received a dose-reduced IA induction regimen. Patients with D5-PBCR+ (n = 65) received IA+homoharringtonine.

Disclosures: This study was supported by the Shanghai Jiao Tong University School of Medicine Multi-Center Clinical Research Project Grant and the National Natural Science Foundation of China. The authors declared no conflict of interests.

Source: Zhang Y et al. Am J Hematol. 2021(Oct 23). Doi: 10.1002/ajh.26386.

Key clinical point: Optimization of a traditional induction regimen with idarubicin and cytarabine (IA) with additional homoharringtonine according to day 5 peripheral blast clearance rate (D5-PBCR) ³99.55% (D5-PBCR−) is feasible in patients with newly diagnosed acute myeloid leukemia (AML) with reversal of unfavorable outcomes observed in patients with D5-PBCR <99.55% (D5-PBCR+).

Major finding: Rates of composite complete remission after 1 cycle of induction (CR1) were 87.5% and 80.0% in D5-PBCR− and D5-PBCR+ groups, respectively, with CR1 rate improving by almost 18% in the D5-PBCR+ group compared with the historical data (P = .049). The median overall survival, event-free survival, and grade 3 or higher adverse events were similar between the 2 groups.

Study details: Findings are from a phase 2 RJ-AML 2014 trial including 151 adult patients with untreated newly diagnosed AML who received a dose-reduced IA induction regimen. Patients with D5-PBCR+ (n = 65) received IA+homoharringtonine.

Disclosures: This study was supported by the Shanghai Jiao Tong University School of Medicine Multi-Center Clinical Research Project Grant and the National Natural Science Foundation of China. The authors declared no conflict of interests.

Source: Zhang Y et al. Am J Hematol. 2021(Oct 23). Doi: 10.1002/ajh.26386.

Key clinical point: Optimization of a traditional induction regimen with idarubicin and cytarabine (IA) with additional homoharringtonine according to day 5 peripheral blast clearance rate (D5-PBCR) ³99.55% (D5-PBCR−) is feasible in patients with newly diagnosed acute myeloid leukemia (AML) with reversal of unfavorable outcomes observed in patients with D5-PBCR <99.55% (D5-PBCR+).

Major finding: Rates of composite complete remission after 1 cycle of induction (CR1) were 87.5% and 80.0% in D5-PBCR− and D5-PBCR+ groups, respectively, with CR1 rate improving by almost 18% in the D5-PBCR+ group compared with the historical data (P = .049). The median overall survival, event-free survival, and grade 3 or higher adverse events were similar between the 2 groups.

Study details: Findings are from a phase 2 RJ-AML 2014 trial including 151 adult patients with untreated newly diagnosed AML who received a dose-reduced IA induction regimen. Patients with D5-PBCR+ (n = 65) received IA+homoharringtonine.

Disclosures: This study was supported by the Shanghai Jiao Tong University School of Medicine Multi-Center Clinical Research Project Grant and the National Natural Science Foundation of China. The authors declared no conflict of interests.

Source: Zhang Y et al. Am J Hematol. 2021(Oct 23). Doi: 10.1002/ajh.26386.