Oncology company BeOne Medicines Ltd (NASDAQ:ONC) (HKEX:06160) (SSE:688235) on Friday announced positive topline results from its Phase 1/2 study of sonrotoclax in relapsed or refractory mantle cell lymphoma (MCL).

The trial met its primary endpoint, with an independent review confirming clinically meaningful overall response rates in heavily pretreated patients.

The global, multi-centre study enrolled 125 adults with MCL who had previously received Bruton's tyrosine kinase inhibitors and anti-CD20 therapy. Results also showed encouraging outcomes across secondary measures including complete response, duration of response, and progression-free survival. The treatment was generally well tolerated, with manageable toxicities.

BeOne plans to submit the data to the US Food and Drug Administration and other regulators worldwide for potential approval. Applications are already under review in China for both MCL and chronic lymphocytic leukaemia/small lymphocytic lymphoma, with potential for accelerated approval.

A Phase 3 confirmatory trial, CELESTIAL-RR MCL, is underway following the FDA's earlier decision to grant sonrotoclax Orphan Drug Designation. BeOne highlighted the findings as a key milestone in its haematology portfolio, which focuses on advancing therapies for B-cell malignancies.