Gamida Cell Ltd. announced the publication in press of a prospective sub-study of the Phase 3 clinical trial for Omisirge®? (omidubicel-onlv), the company's allogeneic stem cell transplant therapy, characterizing immune reconstitution kinetics following hematopoietic stem cell transplantation (HCT) with Omisirge compared to umbilical cord blood (UCB). The article appears online on the Transplantation and Cellular Therapy journal website. Thirty-seven patients (Omisirge: n=17, UCB: n=20) from 14 global sites were included in the sub-study and blood samples were collected from seven to 365 days post-transplantation. Omisirge was found to facilitate faster immune reconstitution, including natural killer (NK) cell and helper T (Th) cell reconstitution than UCB before day 28 post-transplantation. The early reconstitution may account for the reduced rate of viral infections observed after transplantation with Omisirge versus UCB. Patients with a history of allergic reactions to antibiotics should be monitored for allergic reactions following OMISIRGE administration. Infusion reactions occurred following OMISIRGE infusion, including hypertension, mucosal inflammation, dysphagia, dyspnea, vomiting, and gastrointestinal toxicity. Premedication with antipyretics, histamine antagonists, and corticosteroids may reduce the incidence and intensity of infusion reactions. In patients transplanted with OMISIRGE in clinical trials, 47% (55/117) patients had an infusion reaction of any severity. Grade 3-4 infusion reactions were reported in 15% (18/117) patients. Infusion reactions may begin within minutes of the start of infusion of OMISIRGE, although symptoms may continue to intensify and not peak for several hours after the completion of the infusion. Monitor patients for signs and symptoms of infusion reactions during and after OMISIRGE administration. When a reaction occurs, pause the infusion and institute supportive care as needed.
Acute and chronic GvHD, including life-threatening and fatal cases, occurred following treatment with OMISIRGE. In patients transplanted with OMISIRGE Grade II-IV acute GvHD was reported in 58% (68/117). Grade III- IV acute GvHD was reported in 17% (20/117). Chronic GvHD occurred in 35% (41/117) of patients. Acute GvHD manifests as
maculopapular rash, gastrointestinal symptoms, and elevated bilirubin. Patients treated with OMISIRGE should receive immunosuppressive drugs to decrease the risk of GvHD, be monitored for signs and symptoms of GvHD, and treated if GvHD develops. Engraftment syndrome may occur because OMISIRGE is derived from umbilical cord blood. Monitor patients for unexplained fever, rash, hypoxemia, weight gain, and pulmonary infiltrates in the peri-engraftment period. Treat with corticosteroids as soon as engraftment syndrome is recognized to ameliorate symptoms. If untreated, engraftment syndrome may progress to multiorgan failure and death.