HEMATOLOGY

The FDA has granted Fast Track Therapy designation to ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase inhibitor as treatment of patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.

Experts discuss the phase III SIERRA trial, which recently demonstrated durable complete responses in patients with acute myeloid leukemia<br /> &nbsp;

An association was found between a lower risk of grade 3 or higher chemotherapy toxicity with higher body mass indexes and normal albumin, a protein made in the liver, levels in older adult patients with solid tumors, according to an analysis of a prospective, multicenter study.

A phase II trial of ficlatuzumab, an investigational HGF inhibitory antibody, in patients with relapsed and refractory acute myeloid leukemia joins the growing list of clinical trials halted due to the coronavirus disease 2019 pandemic.

A sudden surge in the cases of COVID-19 due to pandemic, along with efforts to contain it, has led to multiple challenges that no country has experienced in the last several decades. The global pandemic from COVID-19 poses a unique set of challenges not only for patients with cancer who need their treatment, but also for caregivers, oncologists, and the overall care team.

In an interview with&nbsp;Targeted Oncology, James L. Ferrara, MD, discussed the prognosis of patients with graft-versus-host-disease and the current treatment strategies. He also highlighted his experience with ruxolitinib and the remaining challenges in this space.

Brad Kahl, MD, discusses the treatment options for patients with indolent lymphomas who are relapsed/refractory.

Efficacy analyses by cell of origin and by MYC and BCL2 double expression status showed a trend toward improved outcomes of patients treated on the polatuzumab vedotin-containing arm regardless of cell of origin or MYC and BCL2 doubkle expression status.

In an interview with&nbsp;Targeted Oncology, Kashyap Patel, MD, discussed the COVID-19 pandemic and the implementation of new precautions in his practice as the number of COVID-19 infected persons rises in the state.<br /> &nbsp;

Venetoclax in combination with azacytidine demonstrated a statistically significant improvement in overall survival and achieved a satisfactory composite complete remission rate in previously untreated patients with acute myeloid leukemia, meeting the co-primary end points of the phase III VIALE-A study. Genentech, the developer of venetoclax, announced the positive news in a press release, also noting that safety profiles of both drugs were consistent with prior reports.

Patients harboring IDH1/2 muta&shy;tions may receive benefit by the use of PARP inhibitors, with investigators initi&shy;ating clinical trials in patients across multiple different tumor types to determine the efficacy of this strategy.

Treatment with pembrolizumab demonstrated antitumor activity along with tolerable toxicity in patients with 4 different rare and hard-to-treat malignancies, according to results from a phase II study led by The University of Texas MD Anderson Cancer Center researchers and published in the&nbsp;Journal for ImmunoTherapy of Cancer.

Treatment with SGX301 led to statistically significant responses in patients with cutaneous T-cell lymphoma, according to preliminary top-line results from the pivotal phase III FLASH trial released by Soligenix.

Bendamustine debulking followed by ofatumumab and ibrutinib demonstrated an overall response rate of 92% in patients with chronic lymphocytic leukemia, meeting the primary end point of the phase II CLL2-BIO trial, and was well-tolerated with no new safety signals. Results from the study were published in&nbsp;Haematologica.

Tatyana Feldman, MD, director of T cell program at the John Theurer Cancer Center, Hackensack Meridian Health, discusses how research is now building upon the positive results from the phase III ECHELON-1 study, which was presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.<br /> &nbsp;

Researchers have developed a baseline score to determine the risk for heart failure in patients with acute leukemias, to address the scarcity in knowledge around the increasing incidence and risk factors of symptomatic heart failure in this patient population. The findings were published in&nbsp;JACC: CardioOncology.

Courtney D. DiNardo, MD, MSCE, discusses what is on the horizon for the acute myeloid leukemia setting.

The FDA has placed a partial clinical hold on the phase I trial of ACTR707 in combination with rituximab in patients with relapsed/refractory B-cell lymphoma from Unum Therapeutics, following the submission of a safety report from the company. The FDA notified Unum of the hold verbally on March 4. Unum Therapeutics acknowledged the partial clinical hold in filings with the Securities and Exchange commission.

In an interview with&nbsp;Targeted Oncology, Eric Kmiec, PhD, discussed the evolution of CRISPR and how it fits into the treatment landscape for physicians in the community practice. He highlights the challenges that arise with the use of CRISPR and how to address these issues.

After demonstrating promising results that were comparable to targeted therapies in the first 2 cohorts of a phase I clinical trial, the combination of cladribine, cytarabine, granulocyte-colony stimulating factor, and mitoxantrone plus the antibody radiation conjugate lintuzumab-Ac225 in patients with relapsed/refractory acute myeloid leukemia is now being explored in a third cohort.

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

In an interview with&nbsp;Targeted Oncology, David S. Hong, MD, discussed the emerging role of multitargeted therapeutics in patients with hematologic malignancies.

As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.

The FDA granted Orphan Drug Designation to umbralisib, an investigational oral PI3K delta inhibitor as treatment for patients with follicular lymphoma, according to a press release from TG Therapeutics. This designation follows a New Drug Application for treatment of marginal zone lymphoma and follicular lymphoma, which was submitted to the FDA in October 2019, based on results from the phase IIb UNITY-NHL study.

Alexey V. Danilov, MD, PhD, discusses important studies in the chronic lymphocytic leukemia space and questions whether combination or sequential therapy is better for patients with chronic lymphocytic leukemia.