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GSK preps filings for BCMA-targeting multiple myeloma drug

On course to file before end of year

GSK

GlaxoSmithKline has more data backing its BCMA-targeting antibodydrug conjugate GSK2857916 in multiple myeloma, setting it on coursefor its first regulatory filings before the end of the year.

The new data from the DREAMM-2 open-label study showed a ‘clinically meaningful’ overall response rate with GSK2857916 (belantamab mafodotin) in myeloma patients who had failed treatment with current drug classes.

GSK is only revealing the top-line win and hasn’t provided detail of the data, but the study seems to back up an earlier open-label trial called DREAMM-1which revealed a 60% ORR with the drug in patients with BCMA-positive myeloma.

GSK2857916 is one of a slew of BCMA-targeting therapies coming through the biopharma industry pipeline, jostling for position with a CAR-T therapy from Celgene and Bluebird Bio called bb2121 (idecabtagene vicleucel) slated for approval next year, and other drugs including a bi-specific antibody from Amgen called AMG 420.

Celgene/Bluebird Bio’s bb2121is currently seen as the frontrunner in the field, although GSK's candidate has now produced comparable median PFS and should be easier to administer. It is the most advanced BCMA-targeting ADC in development, with candidates from AstraZeneca (MEDI2228) and Celgene/Sutro Biopharma (CC-99712) still in early-stage development.

DREAMM-2 looked at two doses of GSK2857916 in both BCMA-positive and BCMA-negative patients who had failed earlier treatment with an immuno-modulatory drug such as Celgene’s Revlimid (lenalidomide), a proteasome inhibitor such as Takeda’s Velcade (bortezomib), as well as Johnson & Johnson’s anti-CD38 antibody Darzalex (daratumumab).

Hal Barron

Hal Barron, chief scientific officer, GSK

GSK said the study would be the basis for regulatory filings for the ADC later this year, and chief scientific officer Hal Barron said he was “excited about what this data could mean for patients with multiple myeloma who have exhausted other lines of treatment”.

That suggests GSK is going for highly-refractory patients in its first marketing applications, with follow-up filings trying to shift the BCMA drug into earlier lines of therapy.

The company is also at the planning stages for a phase 3 trial of the drug – DREAMM-3 – that will compare GSK2857916 to Celgene’s immuno-modulatory drug Pomalust (pomalidomide) plus low-dose dexamethasone in relapsed/refractory myeloma.

It is already recruiting patients into a phase 1/2 trial (DREAMM-4) looking at the combination of the BCMA drug with Pomalyst, as well as six other studies looking at combination regimens as well as first-line therapy.

The myeloma drug market was valued at almost $14bn in 2017, and is forecast to reach nearly $29bn by 2027.

Article by
Phil Taylor

23rd August 2019

From: Regulatory

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