HEMATOLOGY

A new drug application seeking a full approval for duvelisib for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma and an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma has been granted a priority review by the FDA.

Studies have shown that older patients with either active, relapsed, or refractory acute myeloid leukemia have had lower survival rates, poor risk assessments, and limited therapeutic options. The standard care of these patients is salvage chemotherapy. Investigators are pretreating patients in this high-risk population with Iomab-B, a novel radiolabeled antibody–drug conjugate as part of a stem cell transplantation regimen in hopes of improving remission and survival outcomes.

The treatment paradigm of chronic lymphocytic leukemia continues to advance, with many ongoing clinical trials investigating combinations seeking to build upon the success seen with Bruton’s tyrosine kinase inhibitors. Such potential combination therapies for CLL include venetoclax (Venclexta) with either ibrutinib (Imbruvica) or acalabrutinib (Calquence).

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%.

According to results published in <em>The&nbsp;New England Journal of Medicine</em>, molecular minimal residual disease was associated with a higher rate of relapse and a lower rate of relapse-free survival and overall survival for patients with newly-diagnosed acute myeloid leukemia.

Moxetumomab pasudotox has been granted a priority review by the FDA for the treatment of adult patients with hairy cell leukemia (HCL) who have received at least 2 prior lines of therapy, according to AstraZeneca (MedImmune),&nbsp;the developer of the anti-CD22 recombinant immunotoxin.

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&rsquo;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&rsquo;s lymphoma.

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

Stuart L. Goldberg, MD,&nbsp;discussed the management of patients with acute myeloid leukemia as well as those with myelodysplastic syndrome.

Blinatumomab (Blincyto) has been granted an accelerated approval by the FDA for the&nbsp;treatment of patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease.

According to findings from the phase III MURANO trial recently published in the<em> New England Journal of Medicine, </em>the venetoclax&nbsp;(Venclexta) plus rituximab&nbsp;(Rituxan) regimen lowered the risk of disease progression or death by 83% in comparison with bendamustine (Treanda) plus rituximab&nbsp;(Rituxan) in patients with relapsed or refractory chronic lymphocytic leukemia<em>.</em>

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 data from 2 clinical trials, nilotinib&nbsp;(Tasigna) has been approved by the FDA for the first- and second-line treatment of&nbsp;pediatric patients aged 1 year and older with Philadelphia chromosome&ndash;positive chronic myeloid leukemia in the chronic phase.&nbsp;

Since the identification of the role of the JAK kinase family&nbsp;in the late 1980s, awareness of this&nbsp;has grown significantly. These tyrosine<br /> kinases have been proven to transmit a variety of signals into the cells with many biological consequences, adding to the interest in the targetability of the JAK pathway. However,&nbsp;better understanding of the complexities of JAK signaling are being evaluated in clinical trials.

Based on findings from the phase III ECHELON-1 trial,&nbsp;brentuximab vedotin (Adcetris) has been approved by the FDA for use in&nbsp;combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma,&nbsp;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&nbsp;treatment of patients with relapsed/refractory diffuse large B-cell lymphoma.&nbsp;Separate exploratory&nbsp;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.

Lung Cancer

Prithviraj Bose, MD, discussed the findings of 2 combination trials with ruxolitinib to optimize outcomes for patients with myelofibrosis.&nbsp;The JAK inhibitor ruxolitinib is the only FDA-approved therapy for the treatment of patients with myelofibrosis, but novel agents and combination regimens are in development to address some of the unmet needs in the field.

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.