- 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: http://dx.doi.org/10.1016/S1470-2045(17)30064-5
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.
About Adlai Nortye
Adlai Nortye is a science-led biopharmaceutical company dedicated to discovering, developing and commercializing new drugs in the field of oncology/immuno-oncology. Our mission is to improve patient lives by identifying and acquiring differentiated innovative medicines that help people live better and longer. Through close collaboration with global partners, we have successfully positioned ourselves in the fields of immuno-oncology/oncology and have several programs ongoing from early pre-clinical to phase 3 ready.
For further information about Adlai Nortye, please visit: http://www.adlainortye.com/en.php
di Luigi Bisignani
di Gianluca Dodero
di Carlantonio Solimene
di Luigi Salomone
di Massimiliano Lenzi
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