Genentech Enspryng cuts MOGAD relapse risk 68% in Phase III

Phase III METEOROID: primary outcome

METEOROID met its primary endpoint: satralizumab reduced risk of a new MOGAD relapse by 68% versus placebo (time-to-first-relapse; p=0.0025), with response onset around 8 weeks; 87% of patients on satralizumab were relapse-free versus 67% on placebo at 48 weeks.

Efficacy secondary outcomes

Annualized relapse rate decreased 66% (p=0.0030); annualized rate of active MRI lesions across optic nerves, brain and spinal cord fell 79% (p=0.0026); proportion receiving rescue therapy declined 73% (p=0.0024); inpatient hospitalizations were 17% lower versus placebo (p=0.7528, not significant).

Safety

No new safety signals were reported and the safety profile was consistent with prior data; adverse events ≥5% more common with satralizumab included injection-related reactions (16%), influenza (9%), arthralgia (9%), back pain (9%), sinusitis (7%) and diarrhea (6%); treatment interruptions were low (6% satralizumab, 5% placebo); one fatality was reported as not related to treatment and serious AEs were not considered treatment-related.

Study design and next steps

The randomized, double-blind, placebo-controlled METEOROID trial enrolled patients aged ≥12 and used subcutaneous satralizumab (60/120/180 mg by weight) at weeks 0, 2 and 4 then every 4 weeks; the double-blind period was event-driven and ended after 28 adjudicated relapses, with an open-label extension available; data will be submitted to regulatory authorities.