Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

2024-04-17

临床结果临床3期

Roche touts near-complete suppression of multiple sclerosis relapse for injectable Ocrevus

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来源: FiercePharma

The FDA and the European Medicines Agency are expected to deliver a decision on Roche's subcutaneous Ocrevus in September and mid-2024, respectively.

One-year data continued to support a more convenient, injectable version of Roche’s blockbuster multiple sclerosis (MS) drug Ocrevus ahead of an FDA decision, the Swiss pharma said.

A subcutaneous formulation of Ocrevus helped 97% of MS patients achieve no relapse up to 48 weeks of treatment, according to updated data from the phase 3 OCARINA II study presented at the American Academy of Neurology (AAN) annual meeting.

Besides lowering the annual relapse rate to an estimated 0.04, subcutaneous Ocrevus also suppressed brain lesions as shown on MRI imaging by 97%. Most patients had no T1 gadolinium-enhancing lesions or worsening T2 lesions, which are markers of active inflammation and burden of disease, respectively.

The one-year data, showing near-complete suppression of relapse activity and minimal progression of lesion development, are consistent with those of intravenous Ocrevus, Roche’s chief medical officer and head of product development, Levi Garraway, M.D., said in a release Wednesday.

With the under-the-skin version, Roche’s proposal is a more convenient injection that requires only 10 minutes to administer, compared with about two and a half hours—or up to four hours in some patients experiencing side effects—for the currently available intravenous infusion. The subcutaneous formulation requires more drug, at 920 mg per dosing, versus 600 mg for an infusion.

The injection “has the potential to expand the usage of Ocrevus to treatment centers without IV infrastructure or with IV capacity limitations,” Roche said.

Roche has already filed subcutaneous Ocrevus with the FDA and the European Medicines Agency based on 12-week data from the OCARINA II trial showing it matched up to the original infusion in terms of total and peak systemic exposure to the drug in patients with relapsing or primary progressive MS.

The two formulations previously also demonstrated similar depletion of B cells sustained over 24 weeks. Ocrevus is designed to target CD20-positive B cells, which are responsible for inflammatory damage to nerve cells in MS. Because the IV patients were later converted to SC, no 48-week comparison data between the two versions are available.

The FDA and the EMA are expected to deliver a decision in September and mid-2024, respectively.

Roche developed the subcutaneous version with Halozyme Therapeutics’ ENHANZE drug delivery technology, which uses an enzyme to allow large molecules like Ocrevus to be given under the skin.

The drug is currently Roche’s top seller, with 2023 sales reaching 6.38 billion Swiss francs ($7 billion), good for 13% growth over 2022 at constant exchange rates. The CD20 antibody holds about 24% MS patient share across the U.S. and EU5 countries.

The star MS med is facing some competition from Novartis’ rival anti-CD20 molecule, Kesimpta, which comes as a subcutaneous injection. Kesimpta doubled sales in 2023 to $2.17 billion. The drug has secured new-to-brand share leadership in seven of the 10 major markets outside of the U.S., according to Novartis’ report in January.

At the AAN conference, longer-term results from the ALITHIOS open-label extension study showed sustained efficacy for Kesimpta in recently diagnosed patients with relapsing MS. Treatment-naïve patients who went directly to Kesimpta had 44% fewer relapses compared with those who switched to it from Sanofi’s Aubagio.

During the extension study, the annual relapse rate for Kesimpta as a first-line treatment dropped further to 0.05 from 0.104 in the original phase 3 trials. The high proportion of patients with no evidence of disease activity was maintained up to six years, investigators reported at AAN.

Novartis’ Kesimpta, though a subcutaneous injection, is given once a month. With the new Ocrevus formulation, Roche could have a subcutaneous drug that can be given once every six months.

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