LYMPHOMAS

A Priority Review supplemental New Drug Application for selinexor, a selective inhibitor of nuclear export, has been accepted for filing by the FDA, according to the manufacturer, Karyopharm Therapeutics, Inc, in a press release. The application seeks accelerated approval from the agency as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.

In an interview with Targeted Oncology, Jason Westin, MD, discussed findings from a correlative analysis of the cytokine release syndrome and neurotoxicity associated with the chimeric antigen receptor T-cell therapy in the JULIET trial. He highlighted other important takeaways on the data on chimeric antigen receptor cells in diffuse large b-cell lymphoma.

The FDA has granted Priority Review to the New Drug Application for tazemetostat as treatment for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy. The drug will now be considered for accelerated approval and the application was designation as a supplemental NDA with a Prescription Drug User Fee Act target action date of June 18, 2020, Epizyme, Inc announced in a press release.

The FDA has granted Priority Review to the Biologics License Application for lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, after at least 2 prior therapies.

In an interview with Targeted Oncology, Allison J. Moskowitz, MD, discussed the treatment options for patients with Hodgkin lymphoma and what research is still to come in the field. She also compared the treatment landscape of Hodgkin lymphoma with that of T-cell lymphomas, a rare subset of patients.

The aurora A kinase inhibitor alisertib plus the class I histone deacetylase inhibitor romidepsin is a safe combination for the treatment of patients with relapsed/refractory lymphomas, according to the findings from a phase I study whose results were published by Paolo Strati, MD, and colleagues in Haematologica.

Karl M. Kilgore, PhD, discusses the role of chimeric antigen receptor T-cell therapy as treatment of patients with relapsed/refractory diffuse large B-cell lymphoma and where this option might fit into the landscape in the future.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Vincent Herrin, MD - University of Mississippi Medical Center Jackson, Mississippi

Rajat Bannerji, MD, PhD, discusses the safety and efficacy results of REGN1979 in the follicular lymphoma cohort enrolled in the phase I study of patients with relapsed/refractory B-Cell non-Hodgkin lymphoma who were previously treated with an anti-CD20 agent.

In an interview with Targeted Oncology, John M. Burke, MD, discussed the ongoing phase Ib First-MIND clinical trial of tafasitamab in combination with R-CHOP with or without lenalidomide as treatment of patients with newly diagnosed diffuse large B-cell lymphoma.

Elise Chong, MD, discusses the rationale for conducting a 4-year analysis of tisagenlecleucel in patients with relapsed/refractory diffuse large B-cell lymphoma.

A rolling submission of a New Drug Application for umbralisib has been initiated by drug developer, TG Therapeutics, Inc, which is requesting accelerated approval of the agent from the FDA for the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma. The company reported in a press release that one application was considered to be acceptable for both drugs and the NDA will be completed in the first half of 2020.<br /> &nbsp;

In an interview with&nbsp;Targeted Oncology, Rajat Bannerji, MD, PhD, discussed the safety and efficacy findings from the phase I trial of a bispecific antibody in patients with heavily pretreated NHL, including cohorts of patients with follicular lymphoma and diffuse large B-cell lymphoma.

An update to the phase II study of loncastuximab tesirine in patients with relapsed or refractory diffuse large B-cell lymphoma showed promising overall response rate, according to a press release from ADC Therapeutics SA.

The phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in patients with advanced T-cell lymphomas, has been placed on a partial clinical hold by the FDA. The decision was made following discussions regarding Good Manufacturing Practice deficiencies at a subcontractor site that manufacturers the agent&nbsp;in December of 2019, according to a press release from Innate Pharma SA.

In an interview with&nbsp;<em>Targeted Oncology</em>, Constantine S. Tam, MD, discussed the findings of&nbsp;the phase III CAPTIVATE study.&nbsp;

CLR 131, a small-molecule, targeted Phospholipid Drug Conjugate, has been granted Orphan Drug Designation by the FDA for the treatment of patients with lymphoplasmacytic lymphoma, according to a press release from Cellectar BioSciences, Inc, developer of the drug.<br /> &nbsp;

A new drug application for selinexor has been submitted to the FDA for the treatment of patients with relapsed or refractory diffuse large b-cell lymphoma who have had at least 2 prior multi-drug therapies,and who are ineligible for stem cell transplantation, including chimeric antigen receptor T-cell therapy, according to a press release from Karypharm Therapeutics, developer of selinexor.<br /> &nbsp;

A Biologic License Application has been submitted for isocabtagene maraleucel, a chimeric antigen receptor T-cell agent, as a treatment for adult patients with relapsed or refractory large B-cell lymphoma after a minimum of 2 prior therapies, Bristol-Myers Squibb, the manufacturer, reported in a press release.

Following the 2019 ASH Annual Meeting,&nbsp;Targeted Oncology&nbsp;spoke with experts from various specialties in hematology. The experts highlighted some of the top abstracts from the meeting that will impact the way multiple myeloma, leukemias, MPNs, and lymphomas are treated.

Heavily pretreated patients with relapsed/refractory B-cell non-Hodgkin lymphoma demonstrated antitumor activity when treated with varying dose levels of the human IgG4-based anti-CD20 &times; anti-CD3 bispecific&nbsp;monoclonalantibody, REGN1979.&nbsp;

The administration of a higher initial dose of duvelisib at 75 mg BID led to a higher overall response rate of 62% compared with 40% in patients with relapsed/refractory peripheral T-cell lymphoma who received 25 mg BID, according to data from the dose-optimization phase of the PRIMO trial presented at the 2019 American Society of Hematology Annual Meeting.<br /> &nbsp;

In the final analysis of the GADOLIN study in patients with rituximab-refractory indolent non-Hodgkin lymphoma, the combination of obinutuzumab plus bendamustine reduced the risk of progression or death by 43% compared with bendamustine alone. In patients with follicular lymphoma, the reduction was 49%.