Roche and Chugai Announce Phase III LUMINESCE Trial of Satralizumab in Generalized Myasthenia Gravis Misses Clinical Benefit Expectations Despite Statistical Significance

Mar 22, 2024 07:48 CST Updated 07:48

Roche

Oncology Drug Research, Development, and Manufacturing

March 21,RochePartner Chugai Pharmaceutical (Roche) announced Enspryng (Satralizumab) Treatment of Generalized Myasthenia Gravis (gMG) in the Phase III LUMINESCE Study Results. Although statistically significant data were observed in the primary endpoint, the results did not meet expectations for the degree of clinical benefit. Enspryng was well-tolerated in gMG, and its safety profile was consistent with Enspryng's initial indications—Neuromyelitis Optica Spectrum Disorders(NMOSD) is consistent in terms of safety.

Chugai Pharmaceutical stated that the results of the study in gMG do not affect the application of Enspryng in NMOSD. The company is collaborating with Roche to develop Enspryng for other neuro-autoimmune and inflammatory diseases that may benefit from interleukin-6 (IL-6) signal inhibition, including autoimmune encephalitis (AIE), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), and others.ThyroidEye Disease (TED).

Satralizumab is a humanized IgG2 monoclonal antibody developed using SMARTTM recycling technology. It targets the IL-6 receptor and regulates multiple aspects of disease occurrence by blocking IL-6 signal transduction. Satralizumab was successively approved for marketing in Canada, Japan, the United States, and other countries starting from June 2020.

On May 8, 2021, Satralizumab was officially approved for marketing in China, becoming the first treatment drug for Neuromyelitis Optica Spectrum Disorder (NMOSD) in China. It is suitable for treating NMOSD in AQP4 antibody-positive adolescent and adult patients aged 12 years and above.

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