Earlier this week, biotech company bluebird bio released positive interim results from their Phase I clinical trial of CAR-T immunotherapy, in patients with relapsed or refractory multiple myeloma. The dose escalation study showed a 78 percent overall response rate for its investigational anti-B-cell maturation antigen (BCMA), known as bb2121.
“We are pleased that these early data from our ongoing Phase 1 study of bb2121 demonstrate objective anti-tumor responses in heavily pre-treated patients with multiple myeloma,” said Dr. David Davidson, chief medical officer, bluebird bio. “We are also encouraged by the safety profile to date, particularly the lack of severe cytokine release syndrome or neurotoxicity.”
Last week, bluebird’s competitor in the immunotherapy space, Juno Therapeutics, announced that two patients in its CAR-T clinical trial died as a result of a potentially treatment-related adverse event. The deaths prompted Juno to put a hold on the trial for the second time since its launch, and increased the number of CAR-T associated fatalities to six patients.
Earlier this year, the US Food and Drug Administration (FDA) mandated a clinical hold on Juno’s Phase II clinical trial – ROCKET – after two patients died of cerebral edema. Less than one week after the study was put on hold, the FDA allowed the trial to continue after changes were made to the treatment protocol.
So far, bluebird hasn’t reported any serious adverse events related to bb2121, which is being developed alongside pharmaceutical company, Celgene. While bluebird’s CAR-T cell product has shown promising efficacy in interim trial results, the study is still ongoing.
“In light of these positive data,” continued Davidson, “and thanks to the multiple participating clinical sites and centralized manufacturing infrastructure we and our partner Celgene have built for this program, we anticipate efficiently completing the dose escalation stage of the trial and initiating the expansion cohort.”