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A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.
Two-year findings from the ZUMA-1 trial showed an overall survival rate of more than 50% from treatment with axicabtagene ciloleucel, a CD19-targeted CAR T-cell therapy in patients with refractory large B cell lymphoma; the median survival had not yet been reached. These data, representing a clear plateau in the survival curve, were presented at the 2018 ASH Annual Meeting.
An update on the pivotal phase III QuANTUM-R study presented at the 2018 ASH Annual Meeting demonstrated overall survival benefit across patient subgroups with quizartinib in patients with relapsed/refractory <em>FLT3</em>-ITD–mutated acute myeloid leukemia.
A significant reduction in the risk of disease progression or death was observed from treatment with the upfront combination of ibrutinib plus obinutuzumab in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma compared with chlorambucil and obinutuzumab.
Lenalidomide in addition to rituximab, called the R<sup>2</sup> regimen, led to a significant increase in progression-free survival compared with rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma in results from the phase III AUGMENT trial.
Initial results from a phase I study showed an objective response rate of 83.3% had been achieved in heavily pretreated patients with relapsed/refractory multiple myeloma who had been treated with the anti-BCMA CAR T-cell therapy bb21217.
The gold standard of predicting how long patients with myelodysplastic syndromes could live with the disease may soon be replaced by a new approach. According to Aziz Nazha, MD, this newer approach utilizes machine learning to analyze genomic and clinical data from patients to more accurately predict survival.
Mosunetuzumab, a CD3 and CD20 bispecific antibody, induced complete remission rates over 30% in patients with relapsed/refractory follicular lymphoma and relapsed/refractory diffuse large B-cell lymphoma or transformed follicular lymphoma, and demonstrated a tolerable safety profile, showing promise for these patients with B-cell indolent and aggressive non-Hodgkin lymphomas.
According to a presentation of findings from the phase II CLARITY study at the 2018 ASH Annual Meeting, ibrutinib in combination with venetoclax demonstrated tolerability among patients with relapsed/refractory chronic lymphocytic leukemia. The combination also induced minimal residual disease negativity in the marrow in 39% of these patients after 12 months.
Among older patients with acute myeloid leukemia who were ineligible for intensive chemotherapy, preliminary findings demonstrated that more than 70% achieved complete responses to venetoclax in combination with hypomethylating agents.
Peter M. Voorhees, MD, investigator, department of hematologic oncology & blood disorders, Levine Cancer Institute/Atrium Health, discusses efficacy and updated safety findings of a safety run-in cohort from the phase II Griffin trial, a randomized study of daratumumab, bortezomib, lenalidomide, and dexamethasone (Dara-Vrd) versus Vrd in patients with newly diagnosed multiple myeloma eligible for high-dose therapy and autologous stem cell transplantation, during the 2018 ASH Annual Meeting.
It may be possible for hematologists to determine subtypes of acute myeloid leukemia based on genetic analsysis of blood samples in 7 days or less. According to Amy Burd, PhD, this process could play an important role in diagnosing and treating patients.
Pembrolizumab in combination with umbralisib and ublituximab induced responses in 90% of patients with relapsed/refractory chronic lymphocytic leukemia, according to data from a phase I/II study presented at the 2018 ASH Annual Meeting. Additionally, a 50% response rate was also demonstrated in patients with Richter’s transformation.
After 7 years of follow-up, single-agent ibrutinib demonstrated continued efficacy in the frontline and heavily pretreated, relapsed/refractory settings for patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
Lisocabtagene maraleucel induced an 81.3% best overall response rate and 43.8% complete response in high-risk patients with chronic lymphocytic leukemia who were heavily pretreated and had previously received ibrutinib, according to dose-finding results presented at the 2018 ASH Annual Meeting.
According to results from a small clinical study, checkpoint inhibitors in combination with chimeric antigen receptor T-cell therapy showed promise for improving CAR T-cell persistance in some patients with relapsed B-cell acute lymphoblastic leukemia. <br />
Patients with acute lymphoblastic leukemia saw a reduction in the risk for recurrence after receiving a stem cell transplant for the first time following treatment with CD19 chimeric antigen receptor T-cell therapy.
According to a retrospective phase I/II study, over 80% of patients with relapsed or refractory chronic lymphocytic leukemia responded to concurrent treatment with ibrutinib and the CD19-targeted chimeric antigen receptor CAR T-cell therapy, JCAR014.<sup>1</sup> Findings from this study were presented at the 60th American Society of Hematology Annual Meeting.
According to findings from the FLYER trial presented at the 2018 ASH Annual Meeting, treatment with 2 fewer frontline cycles of R-CHOP greatly reduced toxicity in younger patients with low-risk diffuse large B-cell lymphoma. The progression-free survival rates were also similar between the 2 arms.
The need for frequent red blood cell transfusions was reduced with luspatercept in nearly 53% of patients with anemia associated with low- to intermediate-risk myelodysplastic syndrome.
Victor Chow, MD, senior hematology-oncology fellow, University of Washington, Fred Hutchinson Cancer Research Center, Seattle Cancer Care Alliance, discusses a retrospective study assessing outcomes of patients with large B-cell lymphomas and progressive disease following CD19-Specific CAR T-cell therapy during the 2018 ASH Annual Meeting.
After a median of 19 months of follow-up, durable objective response rates were sustained with tisagenlecleucel in patients with relapsed or refractory diffuse large B-cell lymphoma. These updated findings from the phase II JULIET study were presented at the 2018 ASH Annual Meeting.
According to updated data from the phase II ELIANA study, CD19-targeted CAR T-cell therapy tisagenlecleucel as treatment of pediatric and young adult patients with relapsed or refractory acute lymphoblastic leukemia sustained rates of relapse-free survival and overall survival at 24 and 18 months.
Progression-free survival was significantly improved with both ibrutinib as monotherapy and in combination with rituximab when compared to bendamustine plus rituximab as a treatment for older patients with newly diagnosed chronic lymphocytic leukemia. These data were presented at the 2018 ASH Annual Meeting.
Gilteritinib has been approved by the FDA for the treatment of adult patients with <em>FLT3</em> mutation–positive relapsed or refractory acute myeloid leukemia.