Roche’s Ocrevus shows significant benefit in early-stage MS patients

New data for Roche’s Ocrevus has shown significant benefit in patients with early-stage relapsing-remitting multiple sclerosis (RRMS) and primary progressive MS (PPMS), the Swiss pharma announced last week.

The data, presented virtually at the American Academy of Neurology (AAN) annual meeting, comes from the open label phase IIIb ENSEMBLE and a post-hoc analysis of the phase III ORATORIO studies.

In the ENSEMBLE study, 85% of recently diagnosed RRMS patients treated with Ocrevus (ocrelizumab) achieved no evidence of disease activity (NEDA) after 48 weeks.

The average annualised relapse rate (AARR) across all patients was low, according to Roche, with a reduction in neurofilament light chain (NfL) – a marker of nerve cell damage – to nearly healthy control levels with Ocrevus treatment.

The post-hoc analysis of the ORATORIO study also showed that Ocrevus treatment slowed accumulation of atrophied T2-lesion volume (aT2-LV) compared with placebo at 120 weeks in PPMS.

AT2-LV reflects the volume of T2 lesions in brain tissue that is replaced by cerebrospinal fluid, a maker that is believed to be linked to disease progression in MS.

According to Roche, those living with PPMS experience three to five times higher accumulation of aT2-LV compared to people with relapsing MS.

The post-hoc ORATORIO data suggests, therefore, that Ocrevus could favourably impact the underlying progressive biology of MS, Roche said in a statement.

A further, new analysis of US commercial and insurance claims databases found that around 80% of patients adhered to twice-yearly dosing of Ocrevus after their second year of treatment compared with other disease-modifying therapies.

“All patients regardless of their form of MS experience disease progression from the start,” said Levi Garraway, chief medical officer and head of global product development at Roche.

“Therefore, we are encouraged by these new analyses showing that early treatment with Ocrevus may significantly control disease progression in both relapsing-remitting MS and in primary progressive MS. Controlling progression can enable people with MS to maintain mobility and limit their disability,” he added.

The early-stage data bolsters Ocrevus’ claim in the crowded MS market, particularly against Novartis’ Kesimpta (ofatumumab).

Both Kesimpta and Ocrevus selectively target the immune system’s CD20-positive B cells that damage nerve tissue and cause disease progression.