Pharmaceutical giant Roche announced Wednesday that its Phase 3 MUSETTE trial evaluating a high-dose version of multiple sclerosis drug Ocrevus (ocrelizumab) failed to meet its primary endpoint, causing the company's stock to decline while boosting shares of competitor TG Therapeutics.
The trial, which compared a higher dose of Ocrevus to the currently approved 600mg intravenous (IV) dose in adults with relapsing multiple sclerosis (RMS), did not demonstrate additional benefit in slowing disability progression after at least 120 weeks of treatment.
Trial Details and Outcomes
Patients in the MUSETTE study received either the high-dose Ocrevus formulation or the standard 600mg IV dose every 24 weeks for a minimum of 120 weeks. The primary endpoint focused on disability progression, measured by a composite disability score over the treatment period.
Despite the disappointing results for the high-dose version, Roche highlighted that the standard 600mg dose showed clinically meaningful efficacy with the lowest annualized relapse rate (ARR) ever observed during the double-blind period of a Phase 3 study in relapsing multiple sclerosis.
"The rates of disability progression were low and consistent with rates observed in the previous pivotal studies of Ocrevus IV 600 mg," Roche stated in its announcement. The company emphasized that the MUSETTE data further support the efficacy and safety profile of the currently approved Ocrevus IV 600mg dose for RMS.
Market Implications
Following the announcement, Roche shares declined approximately 3.89%, trading at $39.48. Conversely, TG Therapeutics (NASDAQ: TGTX), which develops competing multiple sclerosis therapies, saw its stock rise as investors reassessed the competitive landscape for MS treatments.
The trial results may strengthen TG Therapeutics' market position, as the company continues to advance its own portfolio of MS therapies while Roche faces this development setback.
Current Ocrevus Treatment Options
Ocrevus remains an important therapy in Roche's portfolio and is currently approved in two formulations:
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Ocrevus IV (intravenous): Administered every six months, with the initial dose given as two 300mg infusions two weeks apart, followed by single 600mg infusions for subsequent doses.
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Ocrevus subcutaneous (marketed as OCREVUS ZUNOVO [ocrelizumab hyaluronidase-ocsq] in the U.S.): Administered as a single 920mg subcutaneous injection every six months.
Both formulations are approved for relapsing multiple sclerosis (including relapsing-remitting MS and active or relapsing secondary progressive MS, as well as clinically isolated syndrome in the U.S.) and primary progressive multiple sclerosis.
Multiple Sclerosis Treatment Landscape
Multiple sclerosis is a chronic autoimmune disease affecting the central nervous system, characterized by inflammation, demyelination, and neurodegeneration. The disease affects approximately 2.8 million people worldwide and remains a significant area of unmet medical need despite therapeutic advances.
B-cell depleting therapies like Ocrevus have transformed the treatment landscape for MS in recent years, offering improved efficacy compared to earlier generation treatments. However, the competitive environment continues to evolve as companies seek to develop therapies with enhanced efficacy, improved safety profiles, or more convenient administration options.
The failure of Roche's high-dose Ocrevus trial underscores the challenges in improving upon existing therapies and highlights the complexity of developing treatments for neurological conditions like multiple sclerosis.
