AbbVie Provides Update on VERONA Trial for Newly Diagnosed Higher-Risk Myelodysplastic Syndromes

June 16, 2025: AbbVie announced that the global Phase 3 VERONA trial [NCT04401748] evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome (MDS) did not meet the primary endpoint of overall survival with a hazard ratio of 0.908; stratified log-rank, P=0.377. No new safety signals were observed. Results from the VERONA trial will be presented at a future medical congress and/or published. Any patients who received venetoclax in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician.

NCCN Clinical Practice Guidelines in Oncology.  Multiple Myeloma. Version 1.2026 — June 24, 2025

The latest National Comprehensive Cancer Network guidelines have added daratumumab as a “Category 1” recommendation for high-risk smoldering myeloma.  Based mainly on the recent phase 3 clinical trial AQUILA trial (NCT03301220).  “Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring.”

Intermediate-Dose Cytarabine as Postinduction AML Therapy [Phase 3 clinical trial]

Highlights: 

●      The European Leukemia Net (ELN) mentioned this in its latest recommendations (2022) based on available non-experimental studies:  “Consolidation therapy after attainment of complete remission (CR) patients are consolidated ideally with regimens that include intermediate-dose cytarabine [IDAC]. Although high-dose cytarabine ( [HDAC] 3000 mg/m²) is still used in some centers, its greater toxicity and failure to improve survival argues against its continued use”.

●      This clinical trial (NCT02416388) showed noninferior overall survival (OS) in patients with newly diagnosed AML treated with IDAC versus HDAC; this occurred with similar or lower toxicities; “less, (but not too much less,) is more”. 

Patients 18 to 60 years of age with newly diagnosed AML, except those with core-binding factor, acute promyelocytic, Philadelphia chromosome–positive, or post–myeloproliferative neoplasm AML, were eligible. After the induction course, the patients were randomly assigned to either IDAC (1500 mg/m²/12 hours) or HDAC (3000 mg/m²/12 hours) both given on days 1, 3 and 5. Patients with intermediate- and adverse-risk AML were eligible for allogeneic hematopoietic stem cell transplantation (HSCT) in first remission. The primary analyses were performed in 1132 randomly assigned patients, with a noninferiority outcome adjusted on the ELN 2022 risk group, the use of induction anthracycline, the response to induction, and HSCT as a function of time following treatment.

At 5 years, OS was estimated at 59.3% (95% confidence interval [CI], 55.0 to 63.3) in the IDAC group versus 57.5% (95% CI, 53.3 to 61.5) in the HDAC group (adjusted

hazard ratio, 0.96; 95% CI, 0.80 to 1.15; noninferiority test, P=0.0042). In addition, the severity of chemotherapy-induced myelosuppression and the incidence of related adverse events were lower after IDAC, particularly in those aged ≥50 years.

Platelet Transfusion: 2025 AABB and ICTMG International Clinical Practice Guidelines (Special Communication)

Key Points: We focus on recommendations for adults (see Table 3 in the original article).

1. Strong recommendations (moderate- to high–certainty evidence):

●      Nonbleeding patients with hypoproliferative thrombocytopenia actively receiving chemotherapy or undergoing allogeneic stem cell transplantation (SCT): transfuse if platelet count is <10,000 µL.

●      Patients who are undergoing lumbar puncture: transfuse if platelet count is <20,000 µL.

●      Patients with Dengue-related consumptive thrombocytopenia without major bleeding: no transfusion is recommended.

2. Conditional recommendations (low- to very low–certainty evidence):

●      Nonbleeding adult patients with hypoproliferative thrombocytopenia undergoing autologous (SCT) or who have aplastic anemia: transfusion is not recommended.

●      Adult patients with consumptive thrombocytopenia due to critical illness (non-Dengue) and without major bleeding: transfuse if platelet count is <10,000 µL.

●      Adult patients undergoing central venous catheter placement at a compressible site: transfuse if platelet count is <10,000 µL.

●      Adult patients undergoing interventional radiology procedures: transfuse if platelet count is <20,000 µL for low-risk procedures and <50,000 µL for high-risk procedures.

●      In adults undergoing major nonspinal surgery: transfuse if platelet count is <50,000 µL.

●      Adult patients with spontaneous or traumatic nonoperative intracranial hemorrhage and platelet counts >100,000 µL, including those receiving antiplatelet agents: no transfusion is recommended.

●      Nonthrombocytopenic patients undergoing cardiovascular surgery in the absence of major hemorrhage, including those receiving cardiopulmonary bypass: no transfusion is recommended.

Abstract in 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress - Comparison of Bleeding Risk between Rivaroxaban and Apixaban in Acute Venous Thromboembolism [Phase 3 clinical trial]

The COBRRA Trial (NCT03266783) compared clinically relevant bleeding events between rivaroxaban and apixaban in the treatment of acute venous thromboembolism. In patients with acute symptomatic venous thromboembolism, apixaban use led to significantly fewer clinically relevant bleeding events compared to rivaroxaban during 3 months of treatment. There was no difference in recurrent thrombosis or death rates.

A total of 2760 patients were randomized; 1372 patients were assigned to the apixaban group and 1388 to the rivaroxaban group. The primary outcome (independently adjudicated clinically relevant bleeding events) occurred in 41 of 1346 patients (3.0%) in the apixaban group compared to 91 of 1350 patients (6.7%) in the rivaroxaban group (odds ratio, 0.44; 95% confidence interval, 0.30 to 0.63; P < 0.0001).