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Bristol Myers Squibb Reinforces Efficacy of MS Drug, Zeposia
The Phase 3 trial found 75% and 71% of patients receiving Bristol Myers Squibb’s MS drug at 36 and 48 months were relapse-free, respectively.
Bristol Myers Squibb recently announced interim results from a Phase 3 open-label extension trial, which showed the long-term efficacy and safety profile of Zeposia in patients with relapsing forms of multiple sclerosis (MS).
In the DAYBREAK extension study, 75 percent and 71 percent of patients who received Zeposia at 36 and 48 months were relapse-free, respectively. Researchers also observed three- to six-month confirmed disability progression in 13.9 percent and 11.4 percent of participants in the trial, respectively.
Additionally, 2,143 (85.9 percent) of 2,494 participants experienced a treatment-emergent adverse event (TEAE), 11.9 percent had a serious TEAE, and three percent discontinued treatment due to TEAE.
Notably, safety was consistent with prior findings and no new safety signals were identified during long-term use of Zeposia.
“Early and effective intervention can significantly impact physical and cognitive results over time, with low relapse rates an important indicator of patient outcomes,” Bruce Cree, MD, PD, MAS, study investigator and professor of clinical neurology at the University of California San Francisco (UCSF), Weill Institute for Neurosciences, said in the announcement.
“These data from the DAYBREAK trial provide a clear picture of the long-term safety and efficacy profile of Zeposia, and reinforce its potential when used early in the treatment process for people living with relapsing forms of MS,” continued Cree, who also serves as a clinical research director at UCSF MS Center.
Multiple sclerosis is a disease where the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell.
In March 2020, FDA Zeposia after initially rejecting the drug. Then in June 2020, Bristol Myers Squibb announced that Zeposia 0.92 milligram to treat MS was commercially available in the US.
Zeposia, developed by Celgene, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that provides treatment for patients with no genetic test and no label-based first-dose observation required for patients.
Bristol Myers Squibb acquired Celgene in a $74 billion merger deal in 2019.
The company and its collaborators will present abstracts from the most recent trial findings that reinforce its growing research in MS and commitment to individuals living with the disease.
