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Enrollment has been halted by the FDA on clinical trials of tazemetostat in patients with various solid tumors and hematologic malignancies, according to Epizyme, the manufacturer of the EZH2 inhibitor.

Selina Chen-Kiang, PhD, a professor of pathology and immunology at Weill Cornell Medical College, discusses the rationale of her phase I trial investigating the use of CDK4/6 inhibitors for the treatment of patients with mantle cell lymphoma.

The B-Cell Lymphoma Moon Shot Program at The University of Texas MD Anderson Cancer Center wants to increase the cure rate of the disease from 30% to 60% within 5 years. In a presentation at the <em>22nd Annual</em> International Congress on Hematologic Malignancies, Michael Wang, MD, detailed results from 3 clinical trials that may help make that 5-year goal into a reality for patients with mantle cell lymphoma.

A novel bromodomain and extra terminal protein inhibitor demonstrated promising early activity and a manageable safety profile in the treatment of patients with relapsed or refractory lymphoma in the results of a first-in-human phase I trial.

Owen O’Connor, MD, PhD, director of the Center for Lymphoid Malignancies at New York-Presbyterian Hospital, discusses the possibility of using chimeric antigen receptor (CAR) T-cell therapies for the treatment of patients with mantle cell lymphoma (MCL). This can be tricky for a number of reasons, but O’Connor is hopeful that there are treatment regimens for this patient population that can work.

The field of mantle cell lymphoma underwent a significant change with the FDA approval of ibrutinib in 2013. Now, the recent approval of acalabrutinib has similarly impacted the treatment landscape, as experts say it could be associated with slightly fewer adverse events than ibrutinib, according to Andre Goy, MD.

There was a 16-week complete response rate of 42% per CT imaging with the combination of venetoclax (Venclexta) and ibrutinib (Imbruvica) in patients with previously untreated or relapsed/refractory mantle cell lymphoma, according to results from the phase II AIM study.

According to results from an extended follow-up of the CheckMate-205 trial looking at patients with relapsed/refractory classical Hodgkin lymphoma after autologous hematopoietic cell transplantation, nivolumab (Opdivo) caused an overall objective response rate of 69%.

Miguel-Angel Perales, MD, deputy chief of Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center, discusses what experts are expecting to change in the treatment landscape of non-Hodgkin’s lymphoma in the next year. Perales says by the end of 2018, there may be 3 CAR T-cell therapies approved for the treatment of non-Hodgkin’s lymphoma.

Several new indications were approved by the FDA in March, including blinatumomab (Blincyto) for MRD+ ALL, brentuximab vedotin (Adcetris) for Hodgkin lymphoma, and a 4-week nivolumab (Opdivo) dosing schedule across several indications. Here’s a look back on the FDA happenings for the month of March 2018.

Frederick Locke, MD, co-leader of the Department of Blood and Marrow Transplant and Cellular Immunotherapy Program at Moffitt Cancer Center, discussed the long-term follow-up results of the pivotal ZUMA-1 trial. These updated findings were presented at the 2017 ASH Annual Meeting, showing promise in the treatment of patients with non-Hodgkin lymphoma.

Based on findings from the phase III ECHELON-1 trial, brentuximab vedotin (Adcetris) has been approved by the FDA for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma, according to a statement from Seattle Genetics, the manufacturer of the CD30-targeted antibody-drug conjugate.

Responses to lisocabtagene maraleucel have been potent and durable in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma. Separate exploratory analyses of this population treated with liso-cel found that high tumor burden and a series of in ammatory biomarkers were associated with high chimeric antigen receptor T-cell expansion and higher rates of cytokine release syndrome and neurotoxicity.

Tazemetostat showed efficacy in heavily treated patients with relapsed/refractory non-Hodgkin lymphoma in interim results from a phase II trial. Investigators hope that the analysis of a 62-gene panel biomarker performed on the same patient population will help to identify the patients who will have an even stronger response to the oral EZH2 inhibitor developed by Epizyme.

Anas Younes, MD, chief of the Lymphoma Service at Memorial Sloan Kettering Cancer Center, discusses results from a trial studying the combination of nivolumab and ibrutinib for the treatment of patients with relapsed non-Hodgkin lymphoma and chronic lymphocytic leukemia.

One of the most exciting advancements in the lymphoma community has been the FDA approval of axicabtagene ciloleucel (axi-cel; Yescarta) for patients with non-Hodgkin lymphoma in October 2017.

According to phase I findings published in <em>The Lancet Oncology,</em> an objective response rate of 37% was induced in patients with relapsed/refractory lymphoma or chronic lymphocytic leukemia treated with the PI3K-delta inhibitor umbralisib.

Sattva S. Neelapu, MD, associate professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, at The University of Texas MD Anderson Cancer Center, discusses long-term findings of the ZUMA-1 trial investigating axicabtagene ciloleucel (axi-cel; Yescarta) in patients with refractory aggressive non-Hodgkin lymphoma.

Treatment with the CD19-targeted chimeric antigen receptor T-cell therapy lisocabtagene maraleucel (liso-cel, formally known as JCAR017) demonstrated a complete response rate of 63% and an objective response rate of 81% in patients with relapsed/refractory diffuse large B-cell lymphoma.

Brian T. Hill, MD, PhD, shares more insight on acalabrutinib and ibrutinib’s efficacy in patients with MCL and highlights emerging novel strategies in the treatment landscape.

Lymphoma expert Andrew M. Evens, DO, MSc, FACP, has joined Rutgers Cancer Institute of New Jersey as associate director. He is also serving as medical director of the oncology service line at RWJBarnabas Health. Evens will focus on integrated cancer care delivery in his roles across both institutions.

Peter Martin, MD, discusses a phase I, open-label, multicenter trial of oral azacitidine (Vidaza) plus R-CHOP in people with high-risk, previously untreated DLBCL, grade 3B follicular lymphoma, or transformed lymphoma.

Based on results of the phase II JULIET study, a supplemental biologics license application for the CAR T-cell therapy tisagenlecleucel (Kymriah) has been granted a priority review by the FDA as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma who are ineligible for or relapse after autologous stem cell transplant.

Based on findings from the phase III ECHELON-1 trial, a supplemental biologics application (sBLA) for brentuximab vedotin (Adcetris) in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of advanced classical Hodgkin lymphoma, according to a statement from the company developing the CD30-targeted antibody-drug conjugate, Seattle Genetics.

The combination of brentuximab vedotin (Adcetris) and nivolumab (Opdivo) demonstrated promising clinical activity in patients with relapsed/refractory Hodgkin lymphoma, according to results from a phase I/II trial presented at the 2017 ASH Annual Meeting.










































