LYMPHOMAS

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.

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>&nbsp;an&nbsp;objective response rate of 37% was induced in patients with&nbsp;relapsed/refractory lymphoma or chronic lymphocytic leukemia treated with the&nbsp;PI3K-delta inhibitor umbralisib.

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

Brian T. Hill, MD, PhD,&nbsp;shares more insight on acalabrutinib and ibrutinib&rsquo;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,&nbsp;a supplemental biologics license application for the CAR T-cell therapy tisagenlecleucel (Kymriah) has been granted a priority review by the FDA&nbsp;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&nbsp;supplemental biologics application (sBLA) for&nbsp;brentuximab vedotin (Adcetris)&nbsp;in combination with Adriamycin, vinblastine, and dacarbazine (AVD) has been granted a priority review by the FDA for the frontline treatment of&nbsp;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&nbsp;relapsed/refractory Hodgkin lymphoma,&nbsp;according to results from a phase I/II trial presented at the 2017 ASH Annual Meeting.

Treatment with the novel PD-1 inhibitor cemiplimab induced responses in half of the patients with&nbsp;Hodgkin lymphoma in a phase I study of patients with B-lymphoid malignancies; among patients with&nbsp;B-cell non-Hodgkin lymphoma treated with the monotherapy, the overall response rate was 11.1%, according to a poster presentation at the 2017 ASH Annual Meeting.&nbsp;

Treatment with&nbsp;tisagenlecleucel (Kymriah) continues to excite the possibilities seen with chimeric antigen receptor T-cell therapy with impressive responses seen with the therapy in patients with&nbsp;relapsed/refractory diffuse large B-cell lymphoma. In the phase II JULIET trial, an overall response rate of 53.1%&nbsp;was observed, according to findings presented at the ASH Annual Meeting.&nbsp;

Pembrolizumab (Keytruda) has received a priority review from the FDA for a supplemental biologics license application (sBLA) for the treatment of&nbsp;adult and pediatric patients with relapsed/refractory primary mediastinal large B-cell lymphoma (PMBCL), according to a press release from Merck,&nbsp;the manufacturer of pembrolizumab. The findings were first presented at the 14th International Conference on Malignant Lymphoma and updated data were recently presented at the 2017 ASH Annual Meeting.

Updated results from the TRANSCEND study demonstrated that&nbsp;liso-cel (lisocabtagene maraleucel), formally known as JCAR017, induced an 81% objective response rate and a 63% complete remission rate in patients with relapsed/refractory diffuse large B-cell lymphoma.

The addition of brentuximab vedotin (Adcetris) to doxorubicin, vinblastine, and dacarbazine (A+AVD) reduced the risk of progression and death by 23% in patients with advanced-stage Hodgkin lymphoma (HL) compared with standard&nbsp;ABVD (doxorubicin [Adriamycin], bleomycin, vinblastine, and dacarbazine) chemotherapy, according to results of the phase III ECHELON-1 clinical trial.&nbsp;

Treatment with the chimeric antigen receptor T-cell therapy axi-cel&nbsp;(axicabtagene ciloleucel; Yescarta) demonstrated improvement in long-term survival rates in patients with refractor, aggressive non-Hodgkin lymphoma,&nbsp;according to updated findings from the pivotal ZUMA-1 trial.

Mogamulizumab improved progression-free survival in previously treated patients with cutaneous T-cell lymphoma by 4.6 months compared with vorinostat (Zolinza),&nbsp;according to findings from the phase III MAVORIC study.

Phase Ib results presented at the 2017 ASH Annual Meeting demonstrated that zanubrutinib (BGB-3111), an investigational BTK inhibitor, had encouraging rates of clinical activity in patients with non-Hodgkin lymphoma, including an overall response rate of 78% among patients with marginal zone lymphoma.

A biologics license application for mogamulizumab has been granted a priority review by the FDA for the&nbsp;treatment of patients with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy,&nbsp;Kyowa Hakko Kirin, the manufacturer of the anti-CCR4 monoclonal antibody, has announced.

Brentuximab vedotin&nbsp;(Adcetris) has been submitted for FDA approval in combination with Adriamycin, vinblastine, dacarbazine for the frontline treatment of patients with&nbsp;advanced classical Hodgkin lymphoma.&nbsp;Seattle Genetics,&nbsp;the company developing brentuximab vedotin, recently announced the submission of a&nbsp;supplemental new drug application for the&nbsp;CD30-targeted antibody-drug conjugate.

The CD19-directed CAR T-cell therapy&nbsp;axicabtagene ciloleucel (axi-cel; Yescarta) has been approved by the FDA for the treatment of adults with relapsed or refractory non-Hodgkin lymphoma (NHL), based on complete remission (CR) rate results from the phase II ZUMA-1 trial.