Blincyto Improves Survival for Ph- Relapsed Acute Lymphoblastic Leukemia

In a recent study, Blincyto (blinatumomab) had longer survival rates than standard chemotherapy for certain patients with ALL. 
BY JASON M. BRODERICK @jasoncology
For patients with Philadelphia chromosome–negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), median overall survival (OS) when treated with Blincyto (blinatumomab) was 7.7 months, compared to only four months with standard chemotherapy, according to results of the phase 3 TOWER study published in The New England Journal of Medicine.

The Food and Drug Administration (FDA) granted an accelerated approval to the anti-CD19 immunotherapy Blincyto in December 2014 based on phase 2 data showing strong activity with the treatment in ALL. The accelerated approval was contingent on outcomes from the confirmatory TOWER trial.

"Historically, patients with relapsed or refractory ALL have a poor prognosis, with an overall survival of just four months on standard of care chemotherapy," study author Max S. Topp, M.D., professor and head of Hematology, University Hospital of Wuerzburg, Germany, said in a statement. "Findings from this head-to-head study showed that Blincyto almost doubled the median overall survival from four to 7.7 months, offering these high-risk patients a much needed alternative to chemotherapy that is both innovative and effective."

The open-label phase 3 TOWER trial randomized 405 patients in a 2-1 ratio to Blincyto (271 patients) or investigator’s choice of one of four standard chemotherapy regimens (134 patients). The median patient age was 37 years in both arms. Other baseline characteristics were also well balanced in the Blincyto versus the standard chemotherapy arm, including median bone marrow blasts (80 percent vs 79 percent), prior salvage therapy (56 percent vs 52 percent) and prior allogeneic stem cell transplant (alloSCT; 35 percent vs 34 percent).

Blincyto was administered in six-week cycles of four weeks on (continuous infusion of 9 µg/d in week one of cycle one, then 28 µg/d) and two weeks off. Patients received dexamethasone prior to Blincyto to prevent cytokine release syndrome. If remission was reached following two induction cycles, patients were allowed to receive treatment until relapse. OS was the primary efficacy endpoint. Complete remission (CR) and combined CR or CR with partial or incomplete hematologic recovery (CR/CRh/CRi) were secondary outcome measures.
Treatment with Blincyto reduced the risk of death by 29 percent versus standard chemotherapy. The OS benefit with Blincyto was observed across pre-specified patient subgroups based on age, prior salvage therapy, or alloSCT. The study was halted early for efficacy based on the recommendation of an independent data monitoring committee.

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