DLBCL

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.

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.

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.

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.

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&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.

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.

Peter Martin, MD,&nbsp;assistant professor of medicine in the Division of Hematology/Oncology at Weill Cornell Medical College, Weill Cornell Medicine/NewYork-Presbyterian Hospital, discusses a phase I, open-label, multicenter trial of oral azacitidine (CC-486) plus R-CHOP in patients with high-risk, previously untreated diffuse large B-cell lymphoma, 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.

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;

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.

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.

Martin Dreyling, MD, professor of medicine, University of Munich Hospital in Grosshadern, discusses primary results of the pivotal CHRONOS-1 study, which looked at copanlisib in patients with relapsed or refractory indolent B-cell lymphoma.

Martin Dreyling, MD, discusses results of the&nbsp;phase II CHRONOS-1 study&nbsp;in patients with relapsed or refractory indolent B-cell lymphoma.

Pembrolizumab has been approved by the European Commission for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.