Receive our newsletter – data, insights and analysis delivered to you
  1. News
December 10, 2019updated 24 Dec 2019 7:13am

Bristol-Myers and bluebird report positive data from myeloma study

Bristol-Myers Squibb and bluebird bio have reported positive data from the ongoing Phase I study (CRB-402) of bb21217 for relapsed/refractory multiple myeloma (R/RMM) in patients who did not respond to prior treatments.

Bristol-Myers Squibb and bluebird bio have reported positive data from the ongoing Phase I study (CRB-402) of bb21217 for relapsed/refractory multiple myeloma (R/RMM) in patients who did not respond to prior treatments.

bb21217 is an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy being evaluated to treat patients with R/RMM.

The therapy uses the idecabtagene vicleucel (ide-cel; bb2121) CAR molecule and is cultured with the PI3 kinase inhibitor (bb007) to enrich for T cells displaying a memory-like phenotype to increase the in vivo persistence of CAR T cells.

The two-part, open-label, multi-site Phase I CRB-402 study has been designed to assess the primary endpoint of safety and other pre-defined endpoints, including efficacy and pharmacokinetics measurements.

bluebird bio chief medical officer David Davidson said: “Early data from the CRB-402 study in heavily pre-treated patients (median of six prior lines) with relapsed/refractory multiple myeloma demonstrate the potential for durable responses following bb21217 CAR T cell treatment, with a median duration of response of 11.1 months at the 150 x 106 CAR+ T cell dose level.

“Consistent with the hypothesis underlying the bb21217 programme that memory-like phenotype T cells may survive longer in vivo, we have observed durable CAR T cell persistence in evaluable patients (n=2/2) with ongoing response at up to 18 months following treatment.”

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

The data includes results for 38 treated patients as of the 4 September cutoff date.

As part of the study, 24 patients were given bb21217 in the dose-escalation cohort at three dose levels and another 14 received the therapy in the dose-expansion cohort at two dose levels.

The companies are continuing to recruit additional patients in the study and are performing ongoing assessments of the functional persistence of bb21217.

A total of 74 patients are expected to be enrolled for CRB-402, which is currently in the dose-expansion phase.

The trial will further recruit patients and explore bb21217 at the 450 x 106 CAR+ T cells dose cohort, as well as assess functional persistence of bb21217 and durability of response.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU