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Shell Club (ID: iBio4P) news, April 15, 2021-Arnold Pharma, an innovative global biopharmaceutical company focused on the field of tumor treatment, today announced its oral PI3K inhibitor Buparlisib (AN2025) combined with paclitaxel The global multi-center phase III clinical trial (study name BURAN) for the treatment of recurrent or metastatic head and neck squamous cell carcinoma has successfully completed the first patient administration in Shanghai Oriental Hospital, China, opening up the worldwide use of PI3K drugs in head and neck cancer The first global multi-center large-scale phase III clinical trial in the therapeutic field.
The study is a randomized, open, multi-center phase III clinical study conducted globally to evaluate the efficacy and safety of Buparlisib combined with paclitaxel or paclitaxel alone in the treatment of recurrent or metastatic head and neck squamous cell carcinoma.
The main study endpoint is the patient's overall survival.
This study plans to recruit nearly 500 head and neck squamous cell carcinoma patients in more than 150 research centers in 15 major countries and regions in North America, Europe and Asia Pacific.
The enrollment criteria include those who have received PD-1/PD-L1.
The global incidence of head and neck squamous cell carcinoma ranks eighth among malignant tumors, and the mortality rate ranks twelfth, with approximately 840,000 new cases occurring each year.
Professor Denis Soulières, a well-known expert in the field of global head and neck cancer research and the leader of the study, said: “The results of the previously completed global phase II clinical trial show that Buparlisib (AN2025) has good safety and effectiveness.
"Head and neck squamous cell carcinoma has made great breakthroughs in recent years, but there is still an unmet need for patients with recurrence or metastasis.
Dr.
About squamous cell carcinoma of the head and neck
The global incidence of head and neck squamous cell carcinoma ranks eighth among malignant tumors, accounting for about 90% of all head and neck cancers.
About the BURAN study
The BURAN study is a randomized, open-label, multicenter phase III study to evaluate Buparlisib (AN2025) (once a day) in combination with paclitaxel (once a week) and paclitaxel alone (once a week) for recurrent or metastatic head and neck Efficacy and safety of squamous cell carcinoma (HNSCC).
About Buparlisib (AN2025)
Buparlisib (AN2025) is an oral pan-PI3K inhibitor that targets all PI3K subtypes of class I, and shows anti-tumor activity in hematological malignancies and solid tumors.
About Arnold Pharma
Arnold Pharma is a clinical-stage global biopharmaceutical company focusing on the development of innovative oncology drugs.
Arnold Pharma has established a competitive management team and built a unique drug development technology platform.
