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bluebird bio Reports Updated Results From Pivotal Phase 2 KarMMa Study At ASCO 2020 Virtual Program

bluebird bio, Inc. (NASDAQ:BLUE) announced today that updated results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of idecabtagene vicleucel (ide-cel; bb2121), an investigational B-cell

Benzinga · 05/08/2020 11:31

bluebird bio, Inc. (NASDAQ:BLUE) announced today that updated results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of idecabtagene vicleucel (ide-cel; bb2121), an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, in heavily pre-treated patients with relapsed and refractory multiple myeloma (RRMM) will be presented, in partnership with Bristol Myers Squibb, during the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program beginning on May 29.

Topline results from the KarMMa study were previously disclosed in December 2019. An additional presentation at ASCO20 will include results from a real-world, non-interventional, retrospective study evaluating treatment patterns in heavily pre-treated patients with RRMM compared to outcomes from the KarMMa study.

On Wednesday, May 13 at 5:00 PM ET, accepted abstracts will be available on the ASCO conference website. At that time, the embargo for the data included in the May 29 presentations will lift. The companies plan to issue a data press release at the time of the embargo lift. Video and slide presentations will be available on demand on the ASCO conference website beginning Friday, May 29 at 8:00 AM ET and will remain available for 180 days.

Oral Presentation:

Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): initial KarMMa results

Presenting Author: Nikhil C. Munshi, MD, The LeBow Institute for Myeloma Therapeutics and Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA
Session Title: Hematologic Malignancies- Plasma Cell Dyscrasia
Date & Time: Abstract #8503, Friday, May 29, 2020, 8:00 AM ET

Poster Presentation

KarMMa-RW: A study of real-world treatment patterns in heavily pretreated patients with relapsed and refractory multiple myeloma (RRMM) and comparison of outcomes to KarMMa

Presenting Author: Sundar Jagannath, MD, Mount Sinai Hospital, New York, NY, USA
Session Title: Hematologic Malignancies- Plasma Cell Dyscrasia
Date & Time: Abstract #8525, Friday, May 29, 2020, 8:00 AM ET

About idecabtagene vicleucel (ide-cel; bb2121)

On March 31, 2020, bluebird bio and Bristol Myers Squibb announced the submission of a Biologics License Application for ide-cel to the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Ide-cel is the first chimeric antigen receptor (CAR) T cell therapy submitted for regulatory review to target B-cell maturation antigen (BCMA) and for multiple myeloma.

Ide-cel is a BCMA-directed genetically modified autologous CAR T cell immunotherapy. The ide-cel CAR is comprised of a murine extracellular single-chain variable fragment (scFv) specific for recognizing BCMA, attached to a human CD8 α hinge and transmembrane domain fused to the T cell cytoplasmic signaling domains of CD137 4-1BB and CD3-ζ chain, in tandem. Ide-cel recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells.

Bristol Myers Squibb and bluebird bio’s broad clinical development program for ide-cel includes clinical studies (KarMMa-2, KarMMa-3, KarMMa-4) in earlier lines of treatment for patients with multiple myeloma, including newly diagnosed multiple myeloma. For more information visit clinicaltrials.gov.

Ide-cel is being developed as part of a Co-Development, Co-Promotion and Profit Share Agreement between Bristol Myers Squibb and bluebird bio.

Ide-cel is not approved for any indication in any geography.