Hematologic Oncology

The CAR T-cell therapy tisagenlecleucel (Kymriah) showed similar real-world efficacy and safety findings to that of the JULIET trial in the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma.

Navitoclax plus ruxolitinib (Jakafi) showed clinically meaningful spleen responses and improvements in symptoms for patients with primary or secondary myelofibrosis, following the development of resistance to frontline ruxolitinib.

Ilaria Iacobucci, PhD, staff scientist, St. Jude Children’s Research Hospital, discusses the use of integrated transcriptomic and genomic sequencing in identifying prognostic constellations of driver mutations in acute myeloid leukemia and myelodysplastic syndromes.

Patrick Brown, MD, chair of NCCN Guidelines for Adult and Pediatric ALL, and director of the Pediatric Leukemia Program at Sidney Kimmel Comprehensive Cancer Center, discusses the results of the randomized phase III Children’s Oncology Group Study AALL1331 trial of blinatumomab (Blincyto) versus chemotherapy as post-reinduction therapy in high- and intermediate-risk children and young adults with B-acute lymphoblastic leukemia in first relapse.

Maintenance treatment with CC-486, an oral formulation of azacitidine, extended median overall survival by 9.9 months compared with placebo for older patients with acute myeloid leukemia in first remission.

Blinatumomab (Blincyto) as post-reinduction consolidation therapy before hematopoietic stem cell transplantation improved disease-free survival and overall survival by approximately 20% compared with intensive chemotherapy in pediatric and adolescent and young adult patients with high- or intermediate-risk of first relapse of B-cell acute lymphoblastic leukemia.

Enasidenib significantly improves complete remission and overall response when combined with azacitidine compared with azacitidine alone in patients with newly diagnosed acute myeloid leukemia with IDH2 mutations.

CPI-0610 showed promising spleen volume responses and a meaningful reduction in total symptom score as monotherapy and in combination with ruxolitinib (Jakafi) for patients with refractory or intolerant advanced myelofibrosis.

Vecabrutinib, a reversible, noncovalent Bruton’s tyrosine kinase inhibitor, exhibited evidence of clinical activity in adults with B-cell malignancies without producing any grade ≥3 treatment-related adverse events.

The CD19-directed CAR T-cell therapy lisocabtagene maraleucel showed promising clinical activity and manageable toxicity in heavily pretreated patients with high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma, all of whom had progressed on ibrutinib.

Patients with relapsed/refractory peripheral T-cell lymphoma who received a higher initial dose of duvelisib at 75 mg BID had a higher overall response rate of 62% than those who received 25 mg BID.

More than half of patients with heavily pretreated B-cell malignancies responded to the noncovalent BTK inhibitor LOXO-305, including those with resistance or intolerance to other BTK inhibitors or BCL2 inhibitors.

The combination of lenalidomide (Revlimid) and obinutuzumab (Gazyva) elicited a 100% overall response rate in patients with relapsed indolent non-Hodgkin lymphoma that was refractory to rituximab (Rituxan).

The combination of lenalidomide (Revlimid) and rituximab showed a 34% reduction in the risk of disease progression or death compared with rituximab plus placebo in patients ≥70 years old with indolent non-Hodgkin lymphoma, although it was not found to be statistically significant.

Mosunetuzumab, a novel bispecific antibody, generated durable responses in patients with highly refractory non-Hodgkin lymphomas, including complete remissions in 22.2% of those who had previously received chimeric antigen receptor T-cell therapy.

An investigational new drug application for the therapy, which is labeled FT596, was approved in September 2019 and human trials are scheduled to begin in the first quarter of 2020.

The FDA’s Oncologic Drugs Advisory Committee will not be reviewing an sBLA for luspatercept-aamt for use as a treatment for patients with myelodysplastic syndromes.

Eytan M. Stein, MD, discusses the introduction of novel agents, the relevancy of chemotherapy, and assessing minimal residual disease in acute myeloid leukemia.

Jae H. Park, MD, discusses how emerging agents across several treatment modalities are demonstrating great potential in acute lymphoblastic leukemia.

The FDA has granted a breakthrough therapy designation for abatacept for the prevention of moderate-to-severe acute graft-versus-host disease in patients who have undergone hematopoietic stem cell transplants from unrelated donors.

Alison J. Moskowitz, MD, discusses pivotal data for brentuximab vedotin in Hodgkin and T-Cell Lymphoma, as well as other ongoing developments in these paradigms.

The FDA’s Oncologic Drugs Advisory Committee has scheduled a hearing to review a supplemental Biologics License Application for luspatercept-aamt for use as a treatment for patients with myelodysplastic syndromes.

Eytan M. Stein, MD, discusses the importance of measuring for measurable residual disease in acute myeloid leukemia.

Use of ibrutinib (Imbruvica) significantly increased the risk of early onset hypertension and was associated with long-term risk of developing other major cardiotoxic events in patients with B-cell malignancies.

Raajit K. Rampal, MD, PhD, discusses current available treatments for patients with polycythemia vera and myelofibrosis, as well as the unmet needs in this area of research.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion for a Marketing Authorization Application of fostamatinib disodium hexahydrate for the treatment of adult patients with chronic immune thrombocytopenia who are refractory to other treatments.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the antibody-drug conjugate polatuzumab vedotin for use in combination with bendamustine and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for a hematopoietic stem cell transplant.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of lenalidomide and rituximab for the treatment of adult patients with grade 1 to 3a previously treated follicular lymphoma.

During a recent OncLive Peer Exchange® program, a panel of leukemia experts provided an overview of these agents and shared their perspectives on how clinicians can incorporate them into their clinical practice.

Treatment with the selective ROCK2 inhibitor KD025 led to statistically significant overall response rates in patients with chronic graft-versus-host disease who have received ≥2 prior lines of systemic therapy.