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 8th leading cancer by incidence worldwide and constitutes 90% of all head and neck cancers. The overall annual incidence of HNSCC patients globally reached approximately 0.84 million in 2020, and is expected to increase to approximately 1 million in 2030. Most patients are suffering from locally advanced HNSCC present with a high risk of recurrence; approximately 50-60% of HNSCC patients are diagnosed with metastatic disease. Although immune checkpoint inhibitors have significantly benefited patients with HNSCC, the overall response rates are relatively low in general. Treatment option for patients that do not respond to immune checkpoint inhibitors is increasingly becoming a significant unmet medical need. 

About Adlai Nortye

Adlai Nortye is a global clinical-stage biopharmaceutical company focused on innovative oncology drugs, with its R&D and global clinical operation centers in both China and the United States. With a strategic emphasis on oncology, the Company has built a global pipeline through collaborations and internal discovery with more than 10 drug candidates in development. Currently, three of them are being investigated in clinical trials, including the FDA Fast Track-designated Buparlisib (AN2025) in a global phase III clinical trial; the FDA Fast Track-designated intravenously-administered oncolytic virus Pelareorep (AN1004) to have completed a phase II clinical trial; and an oral EP4 antagonist (AN0025) is in early-stage clinical development in multiple tumor types in combination with other treatment options including chemo-radiation and anti–PD–1/anti–PD–L1 therapies.

The Company has assembled a world-class management team, built its unique immuno-oncology platforms and partnered with multiple top pharmaceutical companies to promote innovation. Adlai Nortye is committed to becoming an innovative biopharmaceutical company with global vision and strives to benefit patients worldwide. The ultimate goal of the Company is to transform cancer into manageable conditions.