HEMATOLOGY

Basem William, MD, discusses challenges in treating patients with cutaneous and peripheral T-cell lymphomas, as well as the challenges in conducting clinical trials in this patient population.

Detailed results of the phase III ADMIRAL trial, which evaluated the use of gilteritinib in adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia, have been published in the New England Journal of Medicine and reaffirm the improved overall survival rate seen with gilteritinib compared with chemotherapy in these patients, according to a press release from Astellas Pharma Inc.

In October 2019, the FDA approved a new treatment option for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer, as well as a new dosing regimen for patients receiving moderately emetogenic chemotherapy. Additionally, the FDA granted breakthrough therapy designations to 2 therapies, as well as an orphan drug designation, a priority review, and 2 fast track designations.

During a recent Targeted Oncology live case-based peer perspectives event, Olga Frankfurt, MD, discussed the complications that could development during the treatment of patients with graft-vs-host disease. Frankfurt explained these complications in the context of a patient who develops acute GVHD after undergoing hematopoietic cell transplant. 

Topline results from Re-MIND, an observational retrospective study, demonstrated that the combination of tafasitamab with lenalidomide had a statistically significant and superior objective response rate compared with lenalidomide monotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma who were not eligible for high-dose chemotherapy and stem cell transplant, announced MorphoSys AG, the manufacturer of tafasitamab, in a press release.

In the phase II biomarker-driven trial combining retinoic acid receptor alpha agonist SY-145 with azacitidine, newly diagnosed adult patients with RARA-positive acute myeloid leukemia who were unfit for intensive chemotherapy continued to show responses to the combination and demonstrate tolerability of the regimen, according to a press release from Syros Pharmaceuticals.

Ublituximab in combination with ibrutinib demonstrated a benefit in progression-free survival over ibrutinib monotherapy, as assessed by an independent review committee, in patients with high-risk relapsed or refractory chronic lymphocytic leukemia in the final long-term results of the phase III GENUINE trial.

John DiPersio, MD, PhD, discusses targeted therapies for myeloid malignancies using DARTs, Bites, and antibody–drug conjugates, a topic he presented during the 2019 Society for Hematologic Oncology Annual Meeting.

The FDA has approved a supplemental New Drug Application for a single dose of aprepitant injectable emulsion for intravenous use in patients receiving moderately emetogenic chemotherapy. The approval expands the dose for aprepitant to include a 130 mg single-dose regimen for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.<br /> &nbsp;

Bemcentinib, a first-in-class AXL inhibitor, has been approved for a fast track designation by the FDA for the treatment of elderly patients with relapsed or refractory acute myeloid leukemia, according to a press release from BerGenBio.<br /> &nbsp;

Ivosidenib in combination with azacitidine demonstrated promising efficacy in addition to being well tolerated in patients with newly diagnosed <em>IDH1</em>-mutant acute myeloid leukemia who were ineligible for intensive chemotherapy.

The FDA has approved a supplemental biologics license application for an updated indication expanding the use of romiplostim in the treatment of adult patients with immune thrombocytopenia to include newly diagnosed patients and patients with persistent ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Emerging from the recent 2019 World Conference on Lung Cancer&nbsp;are several notable developments, Robert L. Ferris, MD, PhD, wrote in this issue of&nbsp;<em>Targeted Therapies in Oncology.&nbsp;</em>

Ruxolitinib demonstrated a significant improvement in overall response rate over best available therapy at day 28 in patients with steroid-refractory acute graft-versus-host disease, according to topline results from the phase III REACH2 trial.&nbsp;Novartis, the company developing the JAK inhibitor, announced in a press release that this met the primary endpoint of the trial.

Among patients with acute myeloid leukemia and myelodysplastic syndrome who completed myeloablative allogeneic hematopoietic stem cell transplantation, the predictive utility of testing circulating tumor DNA was comparable with that of mutation persistence evaluation in matched bone marrow samples, according to a study published recently in Blood.

William G. Wierda, MD, PhD, shares a message with community oncologists about the evolving treatment landscape for patients with chronic lymphocytic leukemia.

Barbara Pro, MD, spoke with a group of physicians during a <em>Targeted Oncology </em>live case-based peer perspectives discussion about the diagnosis, prognosis, and treatment of patients with Hodgkin lymphoma based on the case&nbsp;of a young woman with classic Hodgkin lymphoma.

Marcelo C. Pasquini, MD, discusses the rationale for analyzing real-world data for the use of tisagenlecleucel, a chimeric antigen receptor T-cell therapy, as a treatment for patients with acute lymphoblastic leukemia and diffuse large B-cell lymphoma. This CD19 CAR T cell was approved 2 years ago for use in both ALL and DLBCL.

The addition of direct oral oral anticoagulants for the management of venous thromboembolism in patients with cancer is the latest change to previous guidelines issued by the American Society of Clinical Oncology.

The FDA has granted duvelisib with an orphan drug designation for the treatment of patients with T-cell lymphoma, according to a press release from Verastem Oncology, the company developing duvelisib.<br /> &nbsp;

Using a measure known as the growth modulation index, patients with TRK fusion&ndash;positive cancers who were treated with larotrectinib had a clinically meaningful improvement in progression-free survival compared with the time to progression on their prior treatment, an analysis of patients enrolled in 1 of 3 clinical trials has found.

Due to treatment benefit observed in pediatric patients with acute lymphoblastic leukemia,&nbsp;2 clinical trials investigating blinatumomab (Blincyto) versus chemotherapy were stopped early, according to the drug developer Amgen.

Three clinical trials presented at the 2019 ESMO Congress show that the tropomyosin receptor kinase&nbsp;inhibitor larotrectinib continues to show anti-tumor activity, including long-lasting objective responses and low toxicity, according to results from an integrated analysis.

Umbralisib and ublituximab in combination with pembrolizumab was well tolerated among patients with relapsed/refractory chronic lymphocytic leukemia and Richter&rsquo;s transformation, according to a phase I/II trial presented at the 18th International Workshop on CLL. Responses were durable in high-risk patients who are BTK-refractory, including 2 complete responses in patients with RT.

In an interview with&nbsp;<em>Targeted Oncology</em>, Marcelo C. Pasquini, MD, discussed the importance of obtaining real-world data and establishing registries for collecting patient outcomes, and how real-world data compare with data from pivotal trials. He also explained the challenges with accessibility to CAR T-cell therapies.

The PI3K-delta inhibitor umbralisib demonstrated a favorable toxicity profile as treatment for patients with chronic lymphocytic leukemia who have become intolerant to a prior kinase inhibitor, of either BTK or PI3K inhibition, according to results from a phase II study presented at the 18th International Workshop on CLL.

Bruton tyrosine kinase inhibitor acalabrutinib demonstrated a high rate of response, prolonged survival, and high tolerability in patients with chronic lymphocytic leukemia who demonstrated intolerance to ibrutinib. Findings were presented at the 15th International Conference on Malignant Lymphoma.

Now in it 24th year, the annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma, hosted by Physicians&rsquo; Education Resource, LLC, continues to bring significant advances in hematology to the forefront.

The FDA has granted a fast track designation to abexinostat for the treatment of patients with relapsed or refractory follicular lymphoma in the fourth-line setting.<br /> &nbsp;

Q&amp;A With Moshe Yair Levy, MD: Weighing Risks and Benefits With the Use of Tyrosine Kinase Inhibitors for the Treatment of Chronic Myeloid Leukemia