Adlai Nortye has concluded subject enrolment in the global Phase III BURAN clinical study of buparlisib (AN2025) plus paclitaxel to treat recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

The patient enrolment has been conducted in over 180 sites that span more than 18 markets in Europe, Asia, North America, and South America.

The randomised, multicentre, open-label trial will evaluate the treatment effect of once-a-day buparlisib along with weekly paclitaxel compared to weekly paclitaxel alone in HNSCC patients that have progressed after previous anti–PD–1/anti–PD–L1 monotherapy.

Adlai Nortye president and chief medical officer Lars Birgerson said: “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.”

Buparlisib, an oral pan-PI3K inhibitor designed to target all class I PI3K isoforms, is active in both solid tumours and haematologic malignancies.

The median overall survival was found to be as high as 10.4 months in a global randomised Phase II clinical trial to treat recurrent or metastatic HNSCC with buparlisib and paclitaxel.

Buparlisib received fast track designation from the US Food and Drug Administration (FDA) for this indication.