FDA fast-tracks GSK’s anti-BCMA drug for multiple myeloma

GlaxoSmithKline looks set to win the race to bring a BCMA-targeting drug to market for multiple myeloma, after gaining a priority review in the US. 

The US Food and Drug Administration (FDA) has fast-tracked GSK’s antibody-drug conjugate (ADC) belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma. GSK filed the drug back in December after the drug demonstrated positive results in clinical trials.

The priority review was based on the positive results from a second pivotal trial of the ADC – DREAMM2 – which revealed a 31% overall response rate (ORR) for those receiving the drug who had exhausted multiple previous treatment options for multiple myeloma.

The study participants 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, although less than the 60% seen in GSK’s first trial of the drug, was significant given the patient group were much more sick, and were particularly hard-to-treat.

The priority review is a resounding success for GSK, which is making a push into oncology after it sold the bulk of its cancer portfolio to Novartis a few years ago.

GSK’s new CEO Emma Walmsley (pictured left) and new R&D chief Hal Barron have helmed the company’s re-entry into oncology, having overseen a number of new additions to the oncology pipeline.

This includes belantamab mafodotin, which is a particularly important drug for GSK as it attempts to rebuild its pipeline – although it will face fierce competition in the category as various BCMA-targeting drugs for myeloma are also in late-stage development.

GSK will aim to establish a space in the market for the drug as the standard treatment for use in patients with advanced stages of the disease, who have had no luck with other therapies, including Darzalex.

GSK will also be creating its future plans for the drug, and will be keen to push the ADC into earlier lines of treatment.

The company is at the planning stages for a phase 3 trial of the drug – DREAMM3 – that will compare belantamab mafodotin to Celgene’s immuno-modulatory drug Pomalyst (pomalidomide) plus low-dose dexamethasone in relapsed/refractory myeloma.

It is also set to evaluate the drug in a phase 1/2 trial – DREAMM4 – in combination with Pomalyst, as well as six other studies looking at combination regimens as well as first-line therapy.