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Arnold Pharma, an innovative global biopharmaceutical company focusing on the field of tumor treatment, today announced its oral PI3K inhibitor Buparlisib (AN2025) combined with paclitaxel for the treatment of recurrent or metastatic head and neck squamous cell carcinoma.
The Phase III clinical trial (study name BURAN) has successfully completed the first patient administration in Shanghai Oriental Hospital, China, and opened the world's first global multi-center large-scale phase III clinical trial of PI3K in the treatment of head and neck cancer
.
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
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
.
In recent years, although the emergence of immune checkpoint inhibitors has brought significant clinical benefits to patients with head and neck squamous cell carcinoma, its monotherapy or combined chemotherapy for the overall treatment of recurrent or metastatic head and neck squamous cell carcinoma The response rate is not high
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.
The goal is to provide patients who have progressed after immunotherapy or immunotherapy combined with platinum-containing chemotherapy to provide them with a more effective treatment than paclitaxel
.
"
"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
.
This research is expected to change the pattern of second-line treatment for head and neck squamous cell carcinoma.
Dr.
Lars Birgerson, Chief Medical Officer of Arnold Pharma, said: “Cooperating with the world’s top researchers to carry out clinical trials is a very important part of Arnold Pharma’s global development strategy
.
We hope that Arnold’s products can be effective under such cooperation.