Adlai Nortye Announces the Publication of the Biomarker Analysis From BERIL-1

HANGZHOU, China, July 30, 2018, Adlai Nortye Corporation, a leading biotech company in China, today announced a biomarker analysis publication by the investigators from the phase II study BERIL-1 Buparlisib/Paclitaxel vs Paclitaxel in 2nd Line HNSCC. The study was published by Clinical Cancer Research, June 2018, volume 24, issue 11, titled "Molecular Alterations and Buparlisib Efficacy in Patients With Squamous Cell Carcinoma of the Head and Neck: Biomarker Analysis From BERIL-1".


The paper contains the analysis results of tumor tissue and ctDNA samples collected in the phase II study, and concluded that the BERIL-1 biomarker analyses showed that patients with TP53 alterations, HPV-negative status, low mutational load or above-threshold infiltration of TILs or CD8-positive cells derived survival benefit with the combination of buparlisib and paclitaxel. Early last year, the full phase II study data were also published on The Lancet Oncology Jan. 27, 2017:

Mr. Yang Lu, the CEO of Adlai Nortye stated, "We are firmly committed to bringing Buparlisib to the market for the treatment of HNSCC and the findings in this study provide important direction for the future Buparlisib program (AN2025) in HNSCC. This is in line with Adlai Nortye's strong commitment to developing unique therapeutic options for cancer patients."


Dr. Denis Soulières, medical oncologist at Centre Hospitalier de l'Université de Montréal, Montréal, Canada, principal investigator on BERIL-1 and leading author of the publication, commented, "As investigators and treating physicians we are very excited to see the Buparlisib (AN2025) development moving forward in the HNSCC indication. HNSCC are the 6th most common cancers worldwide and 3rd most common cancers in the developing world. They account for about 5% of all malignancies worldwide and constitute a very important unmet medical need. Buparlisib (AN2025) showed strong results in a randomized trial in the second line setting of HNSCC and could become an important asset for the treatment of these patients." 


About Buparlisib (AN2025)

Buparlisib (BKM120) is an oral pan-PI3K inhibitor that targets all class 1 PI3K isoforms and is active in both hematologic malignancies and solid tumors. It has shown promising efficacy in combination with paclitaxel in head and neck squamous cell carcinoma (HNSCC) and has received a Fast-Track designation from the FDA. Combination of buparlisib and paclitaxel demonstrated improved clinical efficacy with a manageable safety profile in patients with HNSCC compared to paclitaxel alone.