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CLINICAL NEWS
In eight of the 14 ( 57 %), anti-leukemic activity was observed , including six who met International Working Group response criteria ., for an overall response rate of 43 percent .
Two patients had stable disease and bone marrow blast reduction of 20 percent and 25 percent from baseline , respectively . Also , Dr . Uy added , “ when we looked at patients who received doses above 500 nanograms , we saw about
40 to 50 percent of the patients having some evidence of anti-leukemic activity , with about 20 to 30 percent of the patients having measurable responses .” While the results from this earlyphase study will need to be confirmed in larger , randomized trials , they “ support the role for this immune-activating agent in treating AML .” The study continues to enroll patients .
“ The lack of response may be because
certain patients do not express the tumor antigen on their leukemic cells , or because these tumors are able to evade the patient ’ s own immune system , so we are investigating whether checkpoint inhibitors can augment the effects of flotetuzumab ,” he said . “ Next , we are looking at ways to mitigate CRS risk , through better dose optimization , changing dosing schedules , or adding additional agents and different antibodies to different cytokines .”
The authors report financial relationships with MacroGenics , the manufacturer of flotetuzumab .
REFERENCE
Uy GL , Godwin J , Rettig MP , et al . Preliminary results of a phase 1 study of flotetuzumab , a CD123 ´ CD3 bispecific Dart ® protein , in patients with relapsed / refractory acute myeloid leukemia and myelodysplastic syndrome . Abstract # 637 . Presented at the 2017 American Society of Hematology Annual Meeting , December 11 , 2017 ; Atlanta , GA .

Older Patients Underrepresented in Trials of Hematologic Malignancy Treatments

People over the age of 65 represent the majority of those diagnosed with hematologic malignancies , but they account for only about one-third of patients enrolled in clinical trials designed to assess new anti-cancer therapies , according to Bindu Kanapuru , MD , and colleagues at the U . S . Food and Drug Administration ( FDA ).
“ Until now , there has been little information about the enrollment of adults with hematologic cancers ,” Dr . Kanapuru said during her presentation at the 2017 ASH Annual Meeting . “ Based on our findings , the occurrence of cancer is much higher in adults over 75 years , compared with the proportion of patients in this age group who enroll in clinical trials .”
To examine age-related disparities in clinical trial enrollment , investigators conducted a retrospective analysis of trials submitted to the FDA in support of approval of new or supplemental indications for blood-cancer treatments between 2005 and 2015 . The pool comprised 44,144 patients .
Patients were grouped by age (< 65 , 65-74 , and ≥75 years ) and disease type . Enrollment rates were then compared with data on the rate of occurrence of each cancer by age group from the Surveillance , Epidemiology , and End Results ( SEER ) program of the National Cancer Institute between 2010 and 2014 .
Participants were included in trials of treatments for :
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• lymphoma , including chronic lymphocytic leukemia ( CLL ): 45 % ( n = 19,908 )
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