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Pre-BLA Meeting Held With FDA for Omidubicel in Select High-Risk Hematologic Malignancies
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Devimistat, which is being evaluated in combination with modified FOLFIRINOX in the frontline treatment of patients with metastatic adenocarcinoma of the pancreas, failed to meet the primary end point of overall survival in the phase 3 AVENGER 500 trial.

The FDA has granted an accelerated approval to asciminib for patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia (CML) in chronic phase who have previously been treated with 2 or more TKIs, and for those with Ph-positive CML in chronic phase with a T315I mutation.

Yi-Bin Chen, MD, discusses the nuances of diagnosing patients with cGVHD, the need for biomarkers to inform who is likely to develop the disease, the introduction of ruxolitinib and belumosudil to the paradigm, and future directions with novel strategies in the space.

Dr. Abid discusses immune-compromising factors that are indigenous to CAR T-cell therapy recipients, the immunogenic potential of different COVID-19 vaccines, determinants of vaccine responses, and the potential need for booster vaccine dosing in this population.

William G. Wierda, MD, discusses data from the phase 1 cohort of lisocabtagene maraleucel combined with ibrutinib for patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic leukemia that was presented at the 19th International Workshop on CLL (iwCLL) held in September 2021.

Marco Ruiz, MD, discusses the new HIV/Cancer Clinic and its goals, challenges faced with patients who have cancer and HIV infection, and clinical trial opportunities that strive to move the needle forward.

The European Medicines Agency has approved a shorter, 90-minute infusion time for obinutuzumab to be given in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma.

The initiation of the phase 3 ENHANCE trial looks to build on the generally early response to azacitidine with the addition of magrolimab, a first-in-class monoclonal antibody, for patients with intermediate-, high-, and very high–risk myelodysplastic syndrome.

Harry Paul Erba, MD, PhD, spotlights practice-changing data that emerged in recent years in hematologic malignancies and speaks to remaining questions, particularly with CAR T-cell therapy, in each paradigm.

The allogeneic CD19-targeted CAR T-cell therapy CTX110 was found to elicit encouraging responses with favorable tolerability in patients with relapsed or refractory B-cell malignancies, according to data from the phase 1 CARBON trial.

Across the paradigms of leukemias and lymphomas, novel therapies—such as BTK inhibitors, PI3K inhibitors, time-limited therapies, and even CAR T-cell therapies—have transformed the treatment of patients and prolonged survival without the need for chemotherapy.

Bijal Shah, MD, MS, discusses the FDA approval of brexucabtagne autoleucel in relapsed/refractory B-cell acute lymphoblastic leukemia.

Despite early induced efficacy first- and second-generation tyrosine kinase inhibitors have limited efficacy for patients with chronic myeloid leukemia.

Updated data from the phase 3 ASCERTAIN trial demonstrated that the oral, fixed-duration combination of decitabine and cedazuridine induced a median overall survival of 31.7 months in patients with intermediate- and high-risk myelodysplastic syndrome, including chronic myelomonocytic leukemia.

Data from the phase 2 ROCKstar trial demonstrated that belumosudil induced clinically meaningful, durable responses in patients with chronic graft-vs-host disease, irrespective of previous treatment received, severity of disease, and number of organs involved.

The FDA has approved ruxolitinib for the treatment of chronic graft-versus-host disease following failure of 1 or 2 lines of systemic therapy in adult and pediatric patients aged 12 years and older.

Meghan Thompson, MD, discusses the results of the phase 1/2 BRUIN study in patients with Richter transformation.

The triplet combination of umbralisib, ublituximab, and pembrolizumab demonstrated durable responses with a tolerable safety profile in patients with relapsed/refractory chronic lymphocytic leukemia and Richter’s transformation.

Sikander Ailawadhi, MD, discusses the results of a first-in-human, early phase 1 study of lisaftoclax in patients with hematologic malignancies.

Expert hematologist/oncologists review the use of pacritinib for the treatment of myelofibrosis, as seen in the PERSIST-1 and PERSIST-2 trials.

Aaron Gerds, MD, MS; and Srdan Verstovsek, MD, PhD, share insights on the impact of pathways, including JAK-STAT, on myelofibrosis disease progression and discuss considerations for the use of JAK inhibitors.

Optical genome mapping was found to effectively detect most abnormalities defined by standard methods, such as chromosome banding analysis, chromosomal microarrays, and fluorescence in situ hybridization, as well as several additional abnormalities of unknown clinical significance, in patients with chronic lymphocytic leukemia.

Hematology/oncology experts review their approach to monitoring treatment response in myelofibrosis (MF) and when they would consider switching therapies.

Aaron Gerds, MD, MS; and Srdan Verstovsek, MD, PhD, share insights on the importance of allele burden in myelofibrosis (MF) and how cytopenias can limit treatment options for patients with myelofibrosis.

The JAK1/JAK2 inhibitor ruxolitinib has several clinical uses in the treatment of patients with polycythemia vera and plays an especially important role in adult patients who have had an inadequate response to hydroxyurea.


































































