The following data were released at the American Society of Hematology meeting:
Juno Therapeutics Inc., of Seattle, reported that 40 out of 43 evaluable pediatric and young adult patients with relapsed or refractory CD19-positive acute lymphoblastic leukemia (ALL) that were treated with JCAR017, one of its chimeric antigen receptor T cell therapies, experienced a minimal residual disease (MRD)-negative complete remission. All patients who received preconditioning with fludarabine/cyclophosphamide lymphodepletion demonstrated an overall response to the therapy. The estimated 12-month event-free survival is 50.8 percent (95 percent confidence interval 36.9, 69.9) and overall survival is 69.5 percent (95 percent confidence interval 55.8, 86.5). Severe cytokine release syndrome was observed in 23 percent of the patients. The updated data build on information the company had previously presented at the American Society of Clinical Oncology meeting in June. Another study presented at the meeting evaluated Juno's JCAR018 CAR T cell therapy in patients expressing CD22. All of the patients had been previously treated with anti-CD19 CAR T cell therapy and had previously undergone at least one allogeneic stem cell transplant. The primary adverse event during the study was grade 1-2 cytokine release syndrome, with no severe or irreversible neurotoxicity. There was one death due to sepsis in a patient after resolution of CRS. Out of nine patients, three are in ongoing remissions, ranging from three to 12 months. Results showed that seven out of eight patients achieved an MRD-negative complete remission with fludarabine/cyclophosphamide lymphodepletion followed by JCAR018 at dose level 2 (1 x 106 transduced CAR T cells/kg). The study continues to enroll patients.
Celgene Corp., of Summit, N.J., announced the results from two studies evaluating the investigational use of Revlimid (lenalidomide) maintenance therapy in patients with multiple myeloma. The Myeloma XI trial, a U.K.-based, large, randomized, open-label phase III study, included a comparison of investigational lenalidomide maintenance treatment versus no maintenance for patients with newly diagnosed multiple myeloma. The primary endpoint of progression-free survival was 36 months for the 857 patients receiving lenalidomide and 18 months for the 694 patients assigned to an observation arm. (HR:0.45 95 percent CI [0.39, 0.52] P < 0.0001) in the maintenance phase of the study. In the phase III BMT CTN 0702 StaMINA trial, stem cell transplant-eligible patients were randomized following transplant between three arms to receive either four cycles of lenalidomide-bortezomib-dexamethasone (RVD) consolidation therapy, tandem melphalan 200mg/m2 autologous stem cell transplant consolidation, or no consolidation. All arms included lenalidomide maintenance. At a median follow-up of 38 months, all three arms demonstrated comparable progression-free survival and overall survival. The addition of RVD consolidation or a second autologous stem cell transplant was not superior to a single ASCT followed by lenalidomide maintenance.