Roche, Chugai’s Enspryng falls short of expectations in myasthenia gravis study
2024-03-21
临床3期临床结果上市批准
Despite achieving the primary endpoint of a Phase III study in generalised myasthenia gravis (gMG), Chugai Pharmaceutical said that the benefit shown by Enspryng (satralizumab) “did not reach our expectations.” The news buoyed rival argenx, which markets Vyvgart (efgartigimod alfa) for gMG, with the company’s shares climbing 15% on Thursday.
The LUMINESCE trial randomised 188 adults and adolescents 12 years of age and older with gMG to receive Enspryng or placebo, both in combination with standard-of-care therapy. Chugai noted that statistically significant data was seen for the primary endpoint of mean change from baseline in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score at 24 weeks in the anti-AChR-seropositive population.
Approval of Vvygart, including in the US and Europe, was based on findings from the Phase III ADAPT trial in which 68% of anti-AChR-antibody-positive gMG patients were responders on the MG-ADL scale following treatment with the drug, versus 30% for placebo.
Roche leery ahead of data
Ahead of the readout, analysts at Jefferies had highlighted comments made by Chugai’s partner Roche earlier this year as suggesting that theLUMINESCE data may not be as compelling as hoped. The analysts also noted that Roche did not include Enspryng as one of its key growth drivers for 2025 and beyond.
Enspryng, a humanised anti-IL-6 monoclonal receptor antibody, is approved in nearly 90 countries for AQP4-IgG-seropositive neuromyelitis optica spectrum disorder (NMOSD).
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