ASH 2020 Promises Practice Changers in Multiple Myeloma, Bleeding Complications

By Kate O’Rourke

The 2020 American Society of Hematology annual meeting may be virtual this year, but the program includes practice-changing findings for multiple myeloma, bleeding complications, and chronic graft-versus-host disease.

“This year’s annual meeting will be unlike any other meeting we have had in the past,” Robert A. Brodsky, MD, ASH Secretary and director of the division of hematology at Johns Hopkins School of Medicine, said during a webinar previewing the scientific program. “There are approximately 3,500 abstracts to be presented, 750 of which are oral.”

One study expected to impact clinical practice decisions is the Apollo study (Abstract 412), a randomized phase 3 trial showing that the combination of subcutaneous daratumumab plus pomalidomide and dexamethasone was superior to pomalidomide and dexamethasone alone in patients with relapsed/refractory multiple myeloma.

The daratumumab arm was highly effective, Dr. Brodsky reported, showing a 37% reduction in disease progression or death. “The nice thing about this, especially in the COVID era is that this can be administered quickly in the outpatient setting,” he said, noting that the injection duration was about 5 minutes. “This is a big advance and has a high likelihood of changing practice.”

Another practice-changer is the a-TREAT trial (Abstract 2) on the effects of tranexamic acid prophylaxis on bleeding outcomes in hematologic malignancy, which was a negative study. Tranexamic acid is frequently used by hematologists prophylactically in patients who have low platelet counts to decrease bleeding or the need for transfusions, but there is no evidence about its effectiveness, Dr. Brodsky explained.

In the trial of 330 patients with hematologic malignancy undergoing chemotherapy or hematopoietic stem cell transplantation who were randomized to tranexamic acid or placebo, the researchers found no difference in bleeding or the need for transfusion. But they did report an increase in the incidence of central venous line occlusions in the tranexamic arm.

“This is a practice changer in the sense that this probably shouldn’t be given prophylactically to patients with thrombocytopenia,” Dr. Brodsky said.

Dr. Brodsky also highlighted the REACH3 trial (Abstract 77) showing positive outcomes for ruxolitinib versus best available therapy in patients with steroid refractory/steroid dependent chronic graft-versus-host disease. The overall response rate was 50% with ruxolitinib and 26% with best available therapy, making it the first successful phase 3 trial in chronic graft-versus-host disease, Dr. Brodsky noted.

Another potentially practice-changing study is a multicenter biologic assignment trial comparing reduced intensity allogeneic hematopoietic cell transplantation to hypomethylating therapy or best supportive care in patients aged 50 to 75 years with advanced myelodysplastic syndrome (MDS) (Abstract 75).

Bone marrow transplant is currently the standard of care for younger patients with aggressive forms of MDS. But outside of academic medical centers, older patients are not being referred for transplant, Dr. Brodsky said. In an intent-to-treat analysis, the adjusted overall survival at 3 years was 48% versus 27% in favor of bone marrow transplant. The survival advantage was shown in all subgroups, including patients over age 65 years, Dr. Brodsky said.

Several late-breaker abstracts are also expected to make waves. Researchers from England will be presenting data from the multicenter randomized FLIGHT trial of first-line treatment pathways for newly diagnosed immune thrombocytopenia (ITP) that will compare standard steroid treatment and combined steroid and mycophenolate (MMF) (LBA-2). This study showed that MMF may be considered an effective, well-tolerated first-line treatment option, alongside a short course of steroids for some patients with ITP, cutting the risk of refractory or relapsed ITP in half.

Another eagerly expected presentation will feature the efficacy and safety results from the ASCEMBL trial, a multicenter, open-label, phase 3 study of asciminib versus bosutinib in patients with chronic myeloid leukemia (CML) in chronic phase who were previously treated with at least two tyrosine kinase inhibitors (LBA-4). The study found that asciminib demonstrated statistically significant and clinically meaningful superiority in efficacy, compared with bosutinib.

Another late-breaker abstract features the first data from the phase 3 HOPE-B gene therapy trial, which tested the efficacy and safety of etranacogene dezaparvovec in adults with severe or moderate-severe hemophilia B treated irrespective of preexisting anti-capsid neutralizing antibodies (LBA-6).

Genetics is a big area of interest at the ASH meeting, including one study that showed ETNK1 mutations in atypical CML induces a mutator phenotype that can be reverted with phosphoethanolamine (LBA-5).

Stephanie Lee, MD, MPH, ASH President and a professor at the University of Washington, Seattle, urged attendees to take note of four studies investigating disparities in hematology, specifically in leukemia and sickle cell disease.

“I think 2020 really brought a lot of attention to these issues and it really has spurred a nationwide dialogue about the problem and potential solutions,” Dr. Lee said.

These include a study looking at poor treatment outcomes of African American patients under age 60 who were diagnosed with acute myeloid leukemia (AML) (Abstract 6), a study on the role of structural violence in AML outcomes (Abstract 217), a study examining the hospitalization and case fatality in individuals with sickle cell disease and COVID-19 infection (Abstract 16), and a real-world study of COVID-19 outcomes in individuals with sickle cell disease and sickle cell trait, compared with Black individuals without sickle cell disease or trait (Abstract 302).

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