ONO Pharmaceutical Co ((OPHLF)) announced an update on their ongoing clinical study.
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Ono Pharmaceutical Co. Ltd, in collaboration with Deciphera Pharmaceuticals, has launched a Phase 3 clinical trial titled ‘A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants With Relapsed/Refractory Primary Central Nervous System Lymphoma.’ The study aims to evaluate the efficacy and safety of tirabrutinib compared to the combination of rituximab and temozolomide in treating relapsed or refractory primary central nervous system lymphoma (PCNSL).
The trial tests two interventions: tirabrutinib, an experimental drug administered orally, and a combination of rituximab and temozolomide, which serves as the active comparator. Tirabrutinib is given as a monotherapy, while rituximab is administered intravenously and temozolomide orally.
This interventional study follows a randomized, parallel assignment model with no masking, focusing on treatment as its primary purpose. This design allows for a direct comparison between the two treatment regimens.
The study is not yet recruiting, with key dates including a start date of July 29, 2025, and the last update on September 28, 2025. These dates are crucial for investors to track the study’s progress and anticipate potential outcomes.
The market implications of this study could be significant for Ono Pharmaceutical, potentially affecting its stock performance and investor sentiment. Success in this trial could position Ono favorably against competitors in the oncology sector, particularly in treatments for PCNSL.
The study is ongoing, with further details available on the ClinicalTrials portal.