Adlai Nortye, a global biopharmaceutical company focused on developing innovative oncology drugs, today announced that the first patient has been dosed in the global phase III clinical trial (BURAN) at Shanghai Eastern Hospital Medical Center in China. 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.
This trial is a randomized, open-label, multicenter phase III study to evaluate the efficacy and safety of Buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC. The primary endpoint of this study is overall survival (OS) for the entire population of patients. This study plans to recruit approximately 500 HNSCC patients from around 150 clinical centers across 15 major countries and regions in North America, Europe and Asia-Pacific. Enrollment includes patients who have disease 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.
"Results from a previously completed phase II trial have demonstrated that Buparlisib (AN2025) is well tolerated and shows clear clinical benefits," said Professor Denis Soulières, the Primary Investigator of BURAN study." The objective with BURAN is to be able to offer patients with progression after platinum-based and immunotherapy a better option than taxol."
"Although progress has been made in the treatment of patients with HNSCC in recent years, for those with recurrent or metastatic HNSCC, there is still a high unmet medical need. This BURAN study is expected to change the paradigm of second-line treatment for HNSCC, which offers a new treatment option for patients in China and the rest of the world," said Professor Guo Ye, Director of Phase I Clinical Trail Center of Shanghai East Hospital Affiliated to Tongji University and Member of the Head and Neck Cancer Committee of the Chinese Society of Clinical Oncology (CSCO). "As a physician, I am pleased and welcome more and more clinical trials to be carried out in China. This trial will provide us firsthand data in terms of safety and efficacy in Chinese patients with HNSCC and we are looking forward to bringing the best treatment option for them."
"Cooperating with world-class researchers to conduct high-quality clinical trials is an essential part of Adlai Nortye's global strategy," said Dr. Lars Birgerson, Chief Medical Officer of Adlai Nortye. "We hope to provide safer and more effective treatments to patients in a timely manner to ultimately save lives. With an impressive median overall survival of 10.4 months and the FDA granted Fast-Track designation, Buparlisib (AN2025) has the potential to become the first PI3K inhibitor on the market for patients with HNSCC."
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 Buparlisib (AN2025)
Buparlisib (AN2025) 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 phase II clinical trial for the treatment of head and neck squamous cell carcinoma (HNSCC), the median overall survival was as high as 10.4 months. It has received Fast-Track designation and an approval for initiating the phase III clinical study from FDA. The BURAN study investigating Buparlisib is also the first global phase III clinical trial conducted by Adlai Nortye.
About HNSCC
HNSCC is the 8...
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