Therapy with the anti-CD19 bispecific T-cell engager blinatumomab in combination with dasatinib and steroids was safe and feasible in a single-arm trial in 24 patients with a median age of 73 who had a diagnosis of new-onset or relapsed/refractory Ph+ or Ph-like acute lymphoblastic leukemia with dasatinib-sensitive fusions or mutations. The results were published online in Blood Advances in November.
The study aimed to evaluate blinatumomab as post-remission therapy (PRT) instead of chemotherapy. Patients received induction therapy with dasatinib and prednisone. Those not responding by Day 56 received blinatumomab re-induction. Those responding to induction or re-induction received 3 cycles of blinatumomab plus dasatinib, followed by maintenance with dasatinib and prednisone. All patients received 8 doses of central nervous system prophylaxis with intrathecal methotrexate. MRD was assessed by 8-color flow cytometry at Day 28.
With a median of 2.7 years of follow-up, 3-year overall survival was 87% and disease-free survival 77%. No deaths occurred within the first 28 days, pointing to the “excellent tolerability” of blinatumomab in this older patient population, write principal investigator Anjali S. Advani of the Cleveland Clinic Taussig Cancer Institute and colleagues. However, 10 patients discontinued treatment due to side effects.
The trial’s small size and lack of serial molecular measurements are limitations, the authors write.
Nevertheless, “although longer follow up is needed, these results are encouraging, and future trials are building on this backbone regimen,” they write, adding: “It will also be important to examine patterns and mechanisms of relapse with this treatment approach and to explore other novel combination regimens which are ‘chemotherapy-free’ in both younger and older patients with Ph+ ALL.”
Tags: MRD, bispecific t cell engagers, bite, transplantation, Cellular therapy, Survival, BiTEs, cancer, Transplant, T-Cell, remission, t-cell therapy, bispecific, survival rate, t-cell engager