Celgene and bluebird bio have reported positive interim results from CRB-401, the ongoing Phase I trial of bb2121 to treat patients with relapsed and refractory multiple myeloma.

The lead investigational BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy candidate bb2121 is being developed as part of a co-development, co-promote and profit share agreement between Celgene and bluebird bio.

As of the data cut-off date of 30 April 2018, the companies reported manageable safety and deep and durable responses in the first 33 patients infused with bb2121 BCMA-targeted CAR T-cells.

As part of the open-label Phase I CRB-401 study (NCT02658929), Celgene and bluebird are evaluating the preliminary safety and efficacy of bb2121 in patients with relapsed / refractory multiple myeloma.

The primary endpoint of the study is safety.

“We hope that this potentially first-in-class BCMA-targeted CAR T-cell therapy may provide a new treatment option for patients living with multiple myeloma.”

In the dose-escalation phase, cohorts of patients were given ascending doses of bb2121 to determine the maximum tolerated dose, while in the dose expansion phase patients received bb2121 to further evaluate the safety, tolerability and clinical activity at the recommended Phase II dose.

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Celgene Global Clinical Development president Alise Reicin said: “These data from CRB-401 demonstrate that BCMA is a promising target in the treatment of patients with multiple myeloma. We continue to be encouraged by the potential of bb2121 as a first-in-class BCMA-targeted CAR T-cell therapy.

“The compelling data in these heavily pre-treated relapsed / refractory patients has provided important insights in the development of bb2121 as we continue the follow up of patients in our recently fully enrolled pivotal KarMMa trial.”

Treatment with bb2121 resulted in an 85% objective response rate (ORR). In the study, 45% of patients achieved a complete response (CR) and an additional 27% of patients achieved a very good partial response (VGPR).

bluebird bio chief medical officer Dave Davidson said: “The data published in NEJM from CRB-401 provide the foundation for advancing the development of bb2121, which is currently being assessed in multiple clinical studies across different patient populations within multiple myeloma.

“We hope that this potentially first-in-class BCMA-targeted CAR T-cell therapy may provide a new treatment option for patients living with multiple myeloma.”

bb2121 secured Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration in November 2017.