Adlai Nortye Announces Completion of Patient Enrollment in Global Phase III Clinical Trial of Buparlisib (AN2025) in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC

SINGAPORE and NORTH BRUNSWICK, N.J. and HANGZHOU, China, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Adlai Nortye Ltd. (NASDAQ: ANL) (the “Company” or “Adlai Nortye”), a clinical-stage biotechnology company focused on the development of innovative cancer therapies, today announced the Completion of Patient Enrollment in Global Phase III Clinical Trial (BURAN) of Buparlisib (AN2025) in Combination with Paclitaxel for the Treatment of Recurrent or Metastatic HNSCC in more than 180 sites around the world, spanning over 18 markets in North America, Europe, Asia, and South America.

This clinical study evaluates buparlisib (AN2025), an oral pan-PI3K inhibitor, in combination with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This represents the first global multicenter phase III trial for HNSCC in the class of PI3K inhibitors.

"There is a high unmet medical need for patients with recurrent or metastatic HNSCC after anti-PD-1/anti-PD-L1 therapy. As the trial is now fully enrolled, we eagerly look forward to the results which may change the paradigm of second-line treatment for HNSCC and provide a new treatment option for patients worldwide," said Lars Birgerson, President and Chief Medical Officer of Adlai Nortye Ltd.

About BURAN study
The BURAN study is a randomized, open-label, multicenter phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti–PD–1/anti–PD–L1 monotherapy; prior anti–PD–1/anti–PD–L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti–PD–1/anti–PD–L1 therapy, either prior to or post, platinum-based therapy.

About AN2025 (buparlisib)
AN2025 (buparlisib) is an oral pan-PI3K inhibitor that targets all class I PI3K isoforms and is active in both hematologic malignancies and solid tumors. In the global randomized Phase II clinical trial for the treatment of recurrent or metastatic HNSCC with buparlisib in combination with paclitaxel, the median overall survival was as high as 10.4 months (vs. 6.5 months in paclitaxel only group). Buparlisib was granted Fast-Track designation for this indication from the FDA. The ongoing study is the first global Phase III clinical trial conducted by Adlai Nortye.