HEMATOLOGY

Saad Usmani, MD, presents a case of a 75-year-old woman with multiple myeloma.

The submission of a Biologics License Application has been initiated seeking approval of JZP-458 as a part of a multi-agent chemotherapy regimen as treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to E. coli-derived asparaginases.

The FDA granted approval to rituximab-arrx, a biosimilar to rituximab as treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

During a Targeted Oncology Case Based Peer Perspectives event, Miguel-Angel Perales, MD, discussed testing for risk stratification and treatment of graft-versus-host-disease based on the case of a 48-year-old man.

Following the 2020 ASH Annual Meeting, a number of hematology experts shared their insights on the most important data presented during the meeting with Targeted Oncology.

Christian Buske, MD, discusses surprising findings from the 5-Year follow-up of a randomized phase 3 trial in patients with Waldenström’s macroglobulinemia receiving of ibrutinib plus rituximab or placebo plus rituximab.

A phase 1 trial showed early signals of tolerability and efficacy in patients with relapsed or refractory B-cell non-Hodgkin lymphoma with TRPH-222 across dose levels.

An analysis from the MURANO trial showed that venetoclax in combination with rituximab led to a more than doubling of time to next treatment compared with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.

Robert Zeiser, MD, discusses the findings from the phase 3 REACH3 clinical trial of ruxolitinib as treatment of patients with chronic graft-versus-host disease with an inadequate response to corticosteroids.

A study presented during the 2020 ASH Annual Meeting has suggested that certain driver mutations for myeloproliferative neoplasms can be traced back to when they were acquired as early as in utero.

A high objective response rate was observed in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma treated with LOXO-305, according to results of the phase 1/2 BRUIN trial presented during the 2020 ASH Annual Meeting.

Treatment with asciminib led to an almost doubling of the major molecular response rate compared with bosutinib at 24 weeks in patients with chronic-phase chronic myeloid leukemia.

The combination of pevonedistat and azacitidine demonstrated encouraging efficacy and longer event-free survival compared with azacitidine alone in patients with higher-risk myelodysplastic syndromes.

Results for the phase 3 ANDROMEDA study showed an improvement in hematologic complete response rates with the combination of daratumumab plus bortezomib, cyclophosphamide, and dexamethasone compared with VCd alone in patients with newly diagnosed amyloid light-chain amyloidosis.

Chimeric antigen receptor T-cell therapy with lisocabtagene maraleucel led to rapid and durable responses in patients with high-risk relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The precision Treg-engineered donor product Orca-T exhibited preventive potential for graft-versus-host disease in patients with high-risk hematologic malignancies who underwent hematopietic stem cell transplantation, with less immunosuppression compared with the standard of care.

In patients with acute myeloid leukemia and myelodysplastic syndrome, treatment with sabatolimab administered at 200 mg every 2 weeks and 800 mg every 4 weeks demonstrated similar pharmacokinetic activity, according to findings from a dose-selection and dose-response analysis presented during the 2020 American Society of Hematology Annual Meeting.

A research collaboration has identified that patients with hematologic malignancies who are infected with coronavirus disease 2019 are at greater risk for poor outcomes from the virus.

Early signs of clinical activity were observed in adult patients with relapsed/refractory CD22-positive B-cell acute lymphoblastic leukemia who were treated with an investigational allogeneic off-the-shelf CD22-directed therapy.

In a post hoc analysis of the DREAMM-2 trial, belantamab mafodotin achieved deep and durable responses with no notable alterations in its safety profile in heavily pretreated patients with relapsed or refractory multiple myeloma who had received ≥7 prior therapies.

A novel BCMA and CD3 targeted bispecific T-cell engaging immunotherapy agent TNB-383B has demonstrated significant responses at higher dose levels and tolerability at all dose levels, including mild cases of cytokine release syndrome, according to initial results of a phase 1 trial presented during the 2020 American Society of Hematology Annual Meeting.

Allogeneic hematopoietic stem cell transplant with a donor leads to significant improvements in outcomes, even for patients up to age 75, in patients with higher-risk myelodysplastic syndrome.

Treatment with a novel tri-specific natural killer cell engager agent led to natural killer cell proliferation across dose levels in patients with high-risk myelodysplastic syndromes and acute myeloid leukemia.

Patients with intermediate- or high-risk myelofibrosis in the phase 3 SIMPLIFY-1 and SIMPLIFY-2 trials experienced improved overall survival and sustained efficacy outcomes with momelitinib.

Higher doses of telomerase inhibitor imetelstat demonstrated better overall survival, spleen response, and symptom response in patients with myelofibrosis who are relapsed after or refractory to therapy with Janus kinase inhibitors in the phase 2 IMbark study.

The phase 3 REACH3 trial of ruxolitinib in patients with chronic graft-versus-host disease with an inadequate response to corticosteroids demonstrated significantly higher overall response rate, a substantially greater improvement in failure-free survival, and greater symptom improvement compared with best available therapy.

The FDA accepted the New Drug Application from belumosudil and granted it a Priority Review designation for the treatment of patients with chronic graft-versus-host disease. The Prescription Drug User Fee Act target action date has been set to May 30, 2021.

Agents with novel mechanisms of action distinct from available ATP-competitive tyrosine kinase inhibitors have been tested in patients with previously treated, Philadelphia chromosome–positive chronic myeloid leukemia and offer promise to facilitate deeper remissions.

In an interview with Targeted Oncology during the Association for Molecular Pathology 2020 Annual Meeting, Rachel Sparks, MD, discussed the findings observed in hematologic malignancies with the use of a new RNA-based NGS assay.

The FDA has granted a Fast Track designation to rilzabrutinib, an oral investigational Bruton’s tyrosine kinase inhibitor, for the treatment of immune thrombocytopenia. The drug was previously granted Orphan Drug designation for this indication.