This new subcutaneous anticoagulant, abelacimab, binds to the inactive form of FXI and blocks its activation by FXII. This drug seems significantly safer than DOAC’s in terms of bleeding risk. So much so that the study was stopped early due to a greater-than-expected reduction in bleeding events in the study arm. I hope this drug is also going to be studied for the treatment of VTE.
Abelacimab is a fully human monoclonal antibody that binds to the inactive form of factor XI and blocks its activation. The safety of abelacimab as compared with a direct oral anticoagulant in patients with atrial fibrillation is unknown.
Patients with atrial fibrillation and a moderate-to-high risk of stroke were randomly assigned, in a 1:1:1 ratio, to receive subcutaneous injection of abelacimab (150 mg or 90 mg once monthly) administered in a blinded fashion or oral rivaroxaban (20 mg once daily) administered in an open-label fashion. The primary end point was major or clinically relevant nonmajor bleeding.
A total of 1287 patients underwent randomization; the median age was 74 years, and 44% were women. At 3 months, the median reduction in free factor XI levels with abelacimab at a dose of 150 mg was 99% (interquartile range, 98 to 99) and with abelacimab at a dose of 90 mg was 97% (interquartile range, 51 to 99). The trial was stopped early on the recommendation of the independent data monitoring committee because of a greater-than-anticipated reduction in bleeding events with abelacimab. The incidence rate of major or clinically relevant nonmajor bleeding was 3.2 events per 100 person-years with 150-mg abelacimab and 2.6 events per 100 person-years with 90-mg abelacimab, as compared with 8.4 events per 100 person-years with rivaroxaban (hazard ratio for 150-mg abelacimab vs. rivaroxaban, 0.38 [95% confidence interval {CI}, 0.24 to 0.60]; hazard ratio for 90-mg abelacimab vs. rivaroxaban, 0.31 [95% CI, 0.19 to 0.51]; P<0.001 for both comparisons). The incidence and severity of adverse events appeared to be similar in the three groups.
Among patients with atrial fibrillation who were at moderate-to-high risk for stroke, treatment with abelacimab resulted in markedly lower levels of free factor XI and fewer bleeding events than treatment with rivaroxaban. (Funded by Anthos Therapeutics; AZALEA–TIMI 71 ClinicalTrials.gov number, NCT04755283.)
This is another supportive care study that confirms the benefit of Naldemdine in preventing constipation induced by opioids.
THC helped, but had more adverse events, (sedation, dizziness, etc.) THC was in addition to other prophylactic antiemetic, improved response rate from 8 to 24%.
Pooled data of nearly 2000 patients across six trials in melanoma using IO therapy. It seems clear that high dose corticosteroid use was associated with worse outcomes, especially with high peak doses. What may be worth considering is if non-steroid based immunosuppression can be used as an adjunct to blunt this concerning effect.
I guess scalp cooling does have some objective evidence that it works. Still the expense and time constraints will need to be considered.
TIP will likely become the established salvage therapy for GCT’s if this study’s findings are confirmed in the ongoing Phase III TIGER trial.
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