Bluebird – s CAR T-cell Therapy for Myeloma Shows Promise
Bluebird’s CAR T-cell Therapy Shows Promise in Advanced Numerous Myeloma Patients
Patients with advanced numerous myeloma may benefit from bluebird bio’s novel CAR T-cell therapy bb2121, according to data introduced at the twenty eight th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium in Munich, Germany.
The investigate, “Clinical remissions and limited toxicity in a first-in-human multicenter examine of bb2121, a novel anti-BCMA CAR T cell therapy for relapsed/refractory numerous myeloma,” introduced by Yi Lin, MD, PhD, assistant professor of medicine and oncology, Mayo Clinic Division of Hematology in Rochester, Minnesota, exposed promising anti-tumor activity, with several patients exhibiting responses to treatment, including finish responses.
“We are pleased that these early data from our ongoing Phase one examine of bb2121 demonstrate objective anti-tumor responses in strenuously pre-treated patients with numerous myeloma, with all patients in the 15.0 x ten 7 and 45.0 x ten 7 CAR+ T cell dose cohorts achieving responses, including among them, patients with stringent finish responses and elimination of minimal residual disease,” David Davidson, MD, bluebird bio’s chief medical officer, said in a press release.
“We are also encouraged by the safety profile to date, particularly the lack of severe cytokine release syndrome or neurotoxicity. In light of these positive data, and thanks to the numerous participating clinical sites and centralized manufacturing infrastructure we and our fucking partner Celgene have built for this program, we anticipate efficiently completing the dose escalation stage of the trial and initiating the expansion cohort,” Davidson said.
The first-in-human Phase one investigate (NCT02658929) is a two-part, open-label, multicenter trial assessing the safety and effectiveness of the anti-BCMA CAR T-cell therapy bb2121 in patients with relapsed or refractory numerous myeloma. Participants were treated with a median of six prior therapies.
The investigate’s primary endpoint is incidence of adverse events and abnormal lab test results such as dose-limiting toxicities. Secondary endpoints include overall response rate, including partial responses, very good partial responses, and finish responses, according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Numerous Myeloma.
At the time of data cut-off, in November 18th, the explore had already enrolled eleven patients dosed in four dose cohorts. All patients in the mid-dose cohorts responded to the therapy, with two patients in the 2nd dose cohort displaying minimal residual disease-negative accomplish responses.
Importantly, the treatment safety profile was promising, with no dose-limiting toxicities and no Grade three or higher neurotoxicities or cytokine release syndrome being reported by any patient.
