FDA Approval in PMBCL, European Approval in ALL, and 2018 EHA Congress Highlights
Today-
An FDA approval in primary mediastinal B-cell lymphoma, a European approval in acute lymphoblastic leukemia, and highlights from the 2018 European Hematology Association Congress.
Welcome to OncLive News Network! I'm Gina Columbus.
The FDA has granted an accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or those who have relapsed after 2 or more prior lines of therapy.
The decision is based on data from the multicenter, open-label, single-arm KEYNOTE 170 trial, which included 53 patients with relapsed/refractory PMBCL who were treated with pembrolizumab. At a median follow-up of 9.7 months, the overall response rate was 45%, comprising a complete response rate of 11% and a partial response rate of 34%.
Among the 24 responders, the median time to initial objective response was 2.8 months. The median duration of response was not reached.
The FDA stated that it does not recommend pembrolizumab for patients with PMBCL who require urgent cytoreductive therapy. Moreover, the accelerated approval for pembrolizumab in this setting is contingent on the results of a confirmatory trial.
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In acute lymphoblastic leukemia, the European Commission has granted blinatumomab a full marketing authorization for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor disease.
The approval is based on survival data from the phase III TOWER study, in which the median overall survival with blinatumomab was 7.7 months versus 4 months with standard chemotherapy for patients with Ph-negative relapsed/refractory B-cell precursor ALL.
Treatment with blinatumomab reduced the risk of death by 29% versus standard chemotherapy. Among patients receiving blinatumomab as their first salvage treatment, the median OS was 11.1 versus 5.3 months, respectively.
The European Commission previously awarded the agent a conditional marketing authorization in this setting in 2015 that was contingent on data from a confirmatory trial. The full approval applies to countries in the European Union, as well as Norway, Iceland, and Liechtenstein.
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The 2018 European Hematology Association Congress took place in Stockholm, Sweden, this past week, highlighting therapeutic advancements and clinical trial findings in hematologic malignancies.
One ongoing phase I study showed promising findings with a chimeric antigen receptor T-cell therapy that targets CLL1 and CD33, showing a complete remission with minimal residual disease negativity in a single-patient case study in relapsed/refractory acute myeloid leukemia.
The case study presented was of a 44-year-old female patient with relapsed/refractory normal karyotype AML-M4. At baseline, the patient had 71% blasts that dropped to 47% after 4 cycles of standard chemotherapy. Two months following chemotherapy, the patient underwent lymphodepletion with 3 doses of fludarabine. Before introduction of CAR T-cell therapy, the blasts were at 20%.
Nineteen days following infusion, the patient tested MRD-negative. At day 44, she underwent a matched-sibling donor hematopoietic stem cell transplantation and continued to test MRD-negative at months 1, 2, and 3 post transplantation.
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In multiple myeloma, results of the phase II ELOQUENT-3 trial showed that the addition of elotuzumab to pomalidomide and dexamethasone cut the risk of disease progression or death by 46% compared with pomalidomide and dexamethasone alone for patients with relapsed/refractory multiple myeloma.
Data showed that the median progression-free survival was 10.3 months with the elotuzumab combination versus 4.7 months with pomalidomide plus dexamethasone. Additionally, the objective response rate was 53% with elotuzumab compared with 26% in the control arm. The rate of very good partial response or better was 20% versus 9%, with and without elotuzumab, respectively.
Although overall survival results remained immature, they did suggest a trend favoring elotuzumab. There was a 38% reduction in the risk of death in the elotuzumab arm versus the control group. At the data cutoff, there were 13 deaths in the elotuzumab arm and 18 in the control arm.
Elotuzumab was initially approved by the FDA in November 2015 in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who received 1 to 3 prior therapies.
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A third study presented during the meeting highlighted acceptable safety and high response rates with a novel CD-22 targeted chimeric antigen receptor T-cell therapy for pediatric patients with B-cell acute lymphoblastic leukemia who had failed chemotherapy and/or a CD19-targeted CAR T-cell treatment.
In the small study of 15 efficacy-evaluable patients with relapsed or refractory B-ALL, the objective response rate was 86.7% at 30 days' following infusion. Moreover, 80% of patients achieved complete remission or CR with incomplete count recovery. Partial remissions were also achieved in 6.7% of patients.
The 6-month progression-free survival rate was 91.7% in responding patients. Additionally, the CAR T-cell therapy was well tolerated with cytokine release syndrome of mild to medium severity reported in all patients.
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This week, we sat down with Dr Ronald J. Scheff of Weill Cornell Medical College to discuss the REVEL trial of ramucirumab in patients with non-small cell lung cancer.
That's all for today.
Thank you for watching OncLive News Network! I'm Gina Columbus.
