Bluebird to Present Follow-Up Data for CAR T-cell Therapy in Advanced Numerous Myeloma Patients
Patients with advanced numerous myeloma who received three or more lines of therapy have shown promising safety and efficacy results in a Phase one trial assessing bluebird bio’s fresh CAR T-cell therapy bb2121.
Fresh data, to be introduced at the American Society of Clinical Oncology (ASCO) two thousand seventeen Annual Meeting, have shown that the overall response rate for patients included in higher-dose cohorts is 100%, with some responses still ongoing after six months. Treatment-related side effects were mild and manageable.
CAR T-cells are genetically engineered T-cells designed to do a better job of detecting and eliminating cancer cells. The cells are eliminated from a patient and taken to a lab, where they are modified to express a chimeric antigen receptor, or CAR, that is specific to a cancer protein.
Bluebird’s second-generation CAR therapy is designed to target cells voicing the B-cell maturation antigen (BCMA).
The first-in-human Phase one trial (NCT02658929) is a two-part, open-label, multicenter trial testing the safety and effectiveness of bb2121 in patients with relapsed or refractory numerous myeloma. Participants had received at least three prior treatment regimens, including a proteasome inhibitor such as Ninlaro (ixazomib), and an immunomodulatory agent such as Revlimid (lenalidomide). Participants were also required to have at least 50% of their myeloma cells voicing the BCMA protein.
The examine is divided into two parts. In Part A, patients will be assigned escalating doses of bb2121 at fifty million, one hundred fifty million, four hundred fifty million, eight hundred million, and 1.Two billion CAR+ T-cells. Following establishment of the recommended Phase two dose, Part B will include a dose-expansion cohort to further assess the safety and efficacy of the selected dose.
“This past November we introduced the initial clinical data from the very first three dosing cohorts in this ongoing Phase one investigate of bb2121 in patients with relapsed/refractory numerous myeloma. At ASCO in June, we look forward to presenting data on those same patients with longer follow-up, as well as safety and efficacy data on an extra nine patients treated subsequently,” David Davidson, chief medical officer at bluebird bio, said in a press release. “These data will advance our understanding of the bb2121 risk-benefit profile and inform planning with our playmates at Celgene for the dose expansion cohort of this investigate, and the design of a potential pivotal examine.”
The company said that all patients treated with doses of one hundred fifty million cells and higher responded to the treatment, including two accomplish responses and two minimal residual disease-negative responses (patients did not have cancer cells in their bone marrow).
Bluebird also reported that cytokine release syndrome, a common complication caused by systemic activation of T-cells, was mild and manageable, suggesting that bb2121 is a potential therapy for this patient population.