Data from the CELESTIMO study support expanding the therapy to earlier follicular lymphoma.
On 17 September 2026, Roche announced that its Phase III CELESTIMO trial met its primary endpoint. The study evaluated the bispecific antibody Lunsumio in combination with lenalidomide for patients with relapsed or refractory follicular lymphoma.
The trial results support regulatory filings to expand the label for Lunsumio to patients who have received at least one prior systemic therapy. Roche designed the combination for outpatient administration, which aims to reduce capacity strain on hospitals.
Health authority reviews will determine whether the data convert the drug's accelerated approval into full approval and secure access for second-line or later settings. Roche is a Swiss pharmaceuticals and diagnostics group with a market valuation of CHF 289.6 billion, operating across Europe, the Americas, Asia, Africa and Oceania.
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