June 2 (Reuters) - GSK's multiple myeloma drug
Blenrep nearly halved the risk of disease progression or death
compared to standard-of-care treatments for the incurable blood
cancer, according to data from a late-stage study presented at a
medical meeting on Sunday.
In the trial of 302 patients with relapsed or
difficult-to-treat multiple myeloma, 71% of those who received
Blenrep in combination with the steroid dexamethasone and
pomalidomide were alive without their disease worsening at the
end of a year.
That compared with progression-free survival (PFS) of 51% of
those who were treated with pomalidomide, dexamethasone and
bortezomib. Pomalidomide is a generic version of Bristol Myers
Squibb's ( BMY ) Pomalyst, while bortezomib is the generic of
Takeda Pharmaceuticals' Velcade.
"The ability to be able to offer a drug like Blenrep
potentially that is administered on an outpatient basis, does
not require hospitalization, can be available in a community
setting and is not restricted by manufacturing challenges, like
cell therapies, is really important," GSK oncology executive
Hesham Abdullah said in an interview.
Detailed data from the trial was presented at the American
Society of Clinical Oncology meeting in Chicago on Sunday.
Blenrep has had setbacks over the last couple of years,
including being pulled from the lucrative U.S. market in 2022
after it failed to show superiority over an existing treatment
in a separate late-stage study.
The top-line data from this trial released in March showing
it had met the main goal of significantly improving PFS over a
current standard treatment regimen appeared to signal a comeback
for the drug.
More than half of the Blenrep patients were alive without
disease progression after a median follow-up of 21.8 months
compared with 12.7 months PFS for the standard of care, the
company said.
"The PFS benefit seen in the trial shows the potential of
the Blenrep combo, if approved, to redefine the treatment of
multiple myeloma for these patients," GSK said in a statement.
The British drugmaker plans to file marketing applications
with global regulators in the second half of 2024.
Treatments for multiple myeloma include Johnson & Johnson's ( JNJ )
Darzalex and other generic cancer drugs. The U.S. FDA in
April approved two cell therapies - J&J's Carvykti, and Bristol
Myers' Abecma - as earlier lines of treatment in less severe
multiple myeloma.
Eye-related side effects led to a 9% treatment
discontinuation rate from the study but were generally
reversible and manageable through dose modifications, GSK said.
Multiple myeloma, the world's second-most common blood
cancer, starts in plasma cells in bone marrow and ultimately
disrupts production of normal blood cells.
Roughly 35,780 new multiple myeloma cases are likely to be
diagnosed, with 12,540 deaths expected to occur in the United
States this year, according to the American Cancer Society.