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Bluebird’s myeloma CAR-T safety ‘could support outpatient use’

Expects to file with the FDA next year

bluebird

Bluebird Bio and partner Celgene have published data for their BCMA-targeting cell therapy bb2121 for multiple myeloma, reinforcing its position as the frontrunner in the race through development.

The peer-review paper in the New England Journal of Medicine covers data from an ongoing phase 1 study involving 33 patients who had been given at least three prior treatments prior to the CAR-T and had a minimum of six months’ follow-up after bb2121 dosing.

While toxicity is always challenging with CAR-T therapies, the authors say the results showed that the adverse event with bb2121 in the study was “manageable” – potentially making treatment in outpatient settings feasible down the line, according to a HemOnc Today article.

There were low rates of cytokine release syndrome (CRS) and neurotoxicity that have plagued other CAR-T trials, and therapy with bb2121 was associated with an objective response rate (ORR) of 85%, with 15 patients (45%) achieving a complete response.

Six of those complete responders have since relapsed, with an average response time overall of around 11 months and median progression free-survival (PFS) of just under a year, which the authors note is encouraging in this heavily pre-treated patient population. All told, 40% of patients hadn’t relapsed after 12 months.

“We are encouraged by the expansion and persistence of the CAR T-cells, as well as the deep and durable responses with a manageable safety profile we’ve seen for bb2121 to date,” said the trial’s principal investigator James Kochenderfer of the US National Cancer Institute (NCI).

“CAR T-cell therapy is an important area of research for relapsed/refractory multiple myeloma patients where there remains a need for new options,” he added.

bb2121 is now in a pivotal phase 2 trial – called KarMMA – that completed enrolment last November and according to Celgene and Bluebird could pave the way for an FDA filing next year, assuming all goes according to plan.

The two partners will have to move fast to stay ahead of a pack of followers in the anti-BCMA category.

Along with CAR-Ts such as Novartis/Poseida’s P-BCMA-01 and Johnson & Johnson’s LCAR-B38M –incudes other therapeutic approaches in development include GlaxoSmithKline’s antibody-drug conjugate (ADC) GSK2857916 and Amgen’s bispecific antibody AMG 420, both of which have also produced good PFS data.

Article by
Phil Taylor

2nd May 2019

From: Research

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