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BMS and bluebird bio file ide-cel CAR-T for multiple myeloma in US

Ide-cel has breakthrough designation from the FDA

BMS building

Bristol-Myers Squibb and bluebird bio have filed their CAR-T therapy idecabtagene vicleucel to the FDA as a treatment for multiple myeloma, setting up a possible approval before year-end.

The filing of the CAR-T – also known as ide-cel and bb2121 – keeps BMS on the same timeline for the BCMA-targeting cell therapy set by Celgene, which licensed it from bluebird bio in 2018 and was merged into BMS in a $74bn deal last year.

The filing is another boost for investors in Celgene, as ide-cel is one of three drugs that would generate an extra $9-per-share contingent value right (CVR) payment to them on regulatory approval.

BMS has already claimed approval for multiple sclerosis therapy Zeposia (ozanimod), the first of the three, while the second – lisocabtagene maraleucel or liso-cel for lymphoma – is under regulatory review. Celgene investors will get the pay-out if liso-cel is approved by year-end and ide-cel gets a green light before 31 March 2021.

Ide-cel has a breakthrough designation from the FDA so should be ushered through the review process quickly, assuming the regulator is happy with the data on the CAR-T from the phase 2 KarMMa study.

The trial was reported in December and revealed that the CAR-T had an overall response rate of 73%, with remissions lasting 10.6 months on average, and a median progression-free survival of 8.6 months.

BMS and bluebird bio have filed ide-cel for use in relapsed adult myeloma patients already treated with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody such as Johnson & Johnson’s Darzalex (daratumumab) and Sanofi/Regeneron’s Sarclisa (isatuximab), which was approved by the FDA a month ago

BCMA is a protein that is nearly universally expressed on cancer cells in multiple myeloma, says BMS, making it “an important potential target for the treatment of this aggressive blood cancer”.

BMS and bluebird bio are in a race to bring an anti-BCMA therapy to market with GlaxoSmithKline, whose antibody-drug conjugate (ADC) belantamab mafodotin was submitted to the FDA in December.

Like ide-cel, GSK’s ADC is filed for later-line use in myeloma patients already treated with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

Plenty of other BCMA therapies are coming through the clinical pipeline for what is shaping up to be a very competitive myeloma treatment category. That includes a CAR-T from J&J (JNJ-4528), which impressed with a 100% response rate in a  trial reported at the ASH conference last year and is due for filing in the coming months.

There are also bispecific antibodies from Amgen (AMG 420), Regeneron (REGN5458) and bluebird bio/Bristol-Myers Squibb (CC-92369), as well as ADCs from AstraZeneca (MEDI2228) and BMS/Sutro Biopharma (CC-99712).

Article by
Phil Taylor

1st April 2020

From: Research



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