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GSK files anti-BCMA drug for myeloma after second trial win

Important drug for GSK as it rebuilds R&D pipeline

GSK

GlaxoSmithKline has pulled ahead in the race to bring a BCMA-targeting drug to market for multiple myeloma, filing its antibody-drug conjugate belantamab mafodotin in the US.

The FDA submission follows positive results in a second pivotal trial – DREAMM-2 – which revealed a 31% overall response rate (ORR) with the ADC in people with the blood cancer who had exhausted multiple previous treatment options.

Patients in the trial had on average received seven earlier lines of therapy, including an immuno-modulatory drug such as Celgene’s Revlimid (lenalidomide), a proteasome inhibitor such as Takeda’s Velcade (bortezomib), and Johnson & Johnson’s anti-CD38 antibody Darzalex (daratumumab).

The ORR was lower than the 60% seen in GSK’s first pivotal trial DREAMM-1, but that was predictable as the patient group in the latest study were much more sick, according to the company. The new data has just been published in The Lancet Oncology.

Belantamab mafodotin (also known as GSK2857916) is heading up a new push for GSK in oncology after the UK company sold off the bulk of its cancer portfolio to Novartis a few years ago.

It’s an important new drug for GSK as it tries to rebuild its R&D pipeline, but looks set to enter a fiercely competitive category with a series of other BCMA drugs hard on its heels in late-stage development.

The followers include a CAR-T therapy from Celgene and Bluebird Bio called bb2121 (idecabtagene vicleucel) which could also be ready for approval next year, another CAR-T from Johnson & Johnson that recorded a 100% ORR in a trial reported at this year’s ASH conference.

Other drugs making their way through development include 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).

GSK reckons it has the advantage of a solid lead over the other anti-BCMA drug therapies, while GSK2857916 also sidesteps the serious and sometimes life-threatening toxicity that is associated with CAR-T therapies and limits their use in frailer patients.

GSK is filing for later-line use of GSK2857916 in the first instance – in patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody – and will try to move the drug into earlier lines of therapy later.

The ADC has been given a breakthrough designation by the FDA as well as PRIME designation from the EMA in Europe.

Article by
Phil Taylor

17th December 2019

From: Regulatory

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