Roche's Subcutaneous Ocrevus Demonstrates Non-Inferiority to IV Formulation in Phase III MS Trial

Oct 12, 2023 12:01 CST Updated 12:01

Roche

Oncology Drug Research, Development, and Manufacturing

Genentech

Pharmaceutical R&D Manufacturer

Today, Roche and Genentech announced their victory in the subcutaneous formulation of Ocrevus, a drug for multiple sclerosis (MS), and plan to submit Phase 3 data for regulatory approval.

Ocrevus is a humanized monoclonal antibody targeting CD20-positive B cells, a specific type of immune cell considered a key factor in causing damage to myelin and neuronal axons. Ocrelizumab is the first and only therapy approved for RMS and PPMS, with more than 300,000 patients worldwide having received treatment.

In the OCARINA II study, Ocrevus administered subcutaneously twice a year for 10 minutes was compared to the currently approved intravenous formulation in patients with relapsing or primary progressive forms. Over the 24-week study period, the subcutaneous injection provided rapid and sustained B-cell depletion comparable to intravenous infusion, achieving 97% and 98% within two weeks and remaining stable over 24 weeks. The subcutaneous formulation demonstrated pharmacokinetics, biomarkers, and MRI (magnetic resonance imaging) consistent with the intravenous version.

Both formulations also demonstrated complete inhibition of brain lesions, a measure of disease burden.

Genentech's Chief Medical Officer Levi Garraway said in a statement, "Having this additional treatment option may improve the treatment experience for both patients and doctors, and we hope that the twice-yearly dosing will provide better adherence and persistence."

These data will be presented at the upcoming Multiple Sclerosis conference and submitted to regulatory authorities in the coming months.

Currently, Ocrevus has been approved for intravenous formulation. This multiple sclerosis drug generated over $1 billion in sales within a year of its market launch. If another method of administration is approved, sales are expected to increase further, with global sales projected to reach $6.3 billion by 2030.

Ocrevus' current potential competitor is Novartis' Kesimpta, a once-a-month self-injection formulation. Although Ocrevus firmly holds the leading market position, Novartis' drug has shown significant growth. In Q2 2023, Kesimpta's sales reached $489 million, marking a 105% increase compared to the same period last year. Roche's Ocrevus achieved approximately $3.5 billion in sales in the first half of 2023.

References:

1.https://www.biospace.com/article/roche-s-subcutaneous-ocrevus-rivals-iv-formulation-in-phase-iii-ms-trial-/

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