LYMPHOMAS

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.

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.

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.

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;

Jason Westin, MD, MS, FACP, discusses the current treatment options for patients with diffuse large B-cell lymphoma that are available besides rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone.

The largest prospective dataset in previously untreated diffuse large B-cell lymphoma revealed the molecular heterogeneity of diffuse large B-cell lymphoma with potential treatment targets harbored by the cell-of-origin subtypes, based on data from a phase III GOYA study.&nbsp;<br /> &nbsp;

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.

The addition of tazemetostat to rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone was generally well tolerated and demonstrated early anti-tumor activity in patients with newly diagnosed diffuse large B-cell lymphoma, according to the findings from the phase Ib study.

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.

The FDA has granted a fast track designation to tipifarnib for the treatment of adult patients with relapsed or refractory T-cell lymphomas, according to a press release from Kura Oncology, Inc. The fast track designation includes patients with relapsed/refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and nodal peripheral T-cell lymphoma with a T follicular helper phenotype.

Treatment with pembrolizumab resulted in a statistically and clinically significant improvement in progression-free survival compared with brentuximab vedotin in adults patients with relapsed or refractory classical Hodgkin lymphoma , meeting a dual primary end point of the phase III KEYNOTE-204 trial, according to the interim analysis results announced in press release from Merck.

The FDA has granted Priority Review to the newly accepted Biologics License Application for tafasitamab and lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The Prescription Drug User Fee Act target action date was set as August 30, 2020, with no plans for an advisory committee meeting to discuss the application.

To enhance outcomes for patients with indolent non-Hodgkin lymphoma, an in-depth review of the available data is required. As a start, Sonali M. Smith, MD, University of Chicago Medicine, reviewed the clinical trial findings that are currently informing treatment selection in the frontline iNHL paradigm, at 24th Annual&nbsp;International Congress on Hematologic Malignancies.

In an interview with Targeted Oncology, Jason Westin, MD, MS, FACP, discussed the pros and cons of administering R-CHOP in the frontline setting of diffuse large B-cell lymphoma. He also discussed other options for patients who have limited responses to the standard-of-care.

For patients receiving chimeric antigen receptor T-cell therapy, cytokine release syndrome and neurotoxicity are the most common toxicities. A multidisciplinary approach to care is vital for these patients, explained Kimberly Noonan, DNP, ANP-BC, AOCN, in a presentation during the&nbsp;24th Annual&nbsp;International Congress on Hematologic Malignancies.

Sameer Desai, MD, discusses the changing treatment landscape for lymphomas.

Because diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma in the US, clinical investigators are eager to make progress with novel agents, despite recent advances, said Craig Moskowitz, MD, in a presentation during the 2020 International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma.<br /> &nbsp;

Lori A. Leslie, MD, discusses chimeric antigen receptor T-cell therapy as a treatment for diffuse large B-cell lymphoma and the positive results demonstrated for this agent in patients with relapsed/refractory disease.

In an interview with&nbsp;Targeted Oncology,&nbsp;Stephen J. Schuster, MD, discussed the findings for mosunetuzumab in patients with relapsed/refractory non-Hodgkin lymphoma and the particularly promising findings for those patients who had received prior chimeric antigen receptor T-cell therapy.

Combining the antibody-drug conjugate polatuzumab vedotin with bendamustine and rituximab resulted in a significantly higher complete response rate in patients with transplantation-ineligible relapsed/refractory diffuse large B-cell lymphoma compared with patients who received BR alone. The international, multicenter, open-label, phase Ib/II trial also found that pola-BR reduced the risk of death by 58%, according to a recent Journal of Clinical Oncology paper.

Evaluation of an expansion cohort of the pivotal phase I/II ZUMA-1 trial in patients with refractory large B-cell lymphoma revealed that early steroid intervention may have a positive impact on the toxicity profile of chimeric antigen receptor T-cell therapy with axicabtagene&nbsp;ciloleucel, according to findings presented during a poster session at the 2020 Transplantation &amp; Cellular Therapy Meetings in Orlando, Florida.

John M. Pagel, MD, PhD, discusses the current setting of diffuse large B-cell lymphoma and some of the treatments available at the moment.

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.&nbsp;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&nbsp;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&nbsp;phase I study&nbsp;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.