Arno Pharmaceuticals PI3K inhibitor Buparlisib (AN2025) has been approved for phase 3 clinical trials at the International Multicenter.

Clinical trial simplied license (source: CDE) Buparlisib is an oral pan-PI3K inhibitor for all Class I PI3K subtypes that can be used in the treatment of hematologic malignancies and solid tumors.
previously completed global Phase 2 clinical treatment, the product and yew alcohol combination therapy after platinum chemotherapy recurrence or transgenic head and neck squamous cell carcinoma, the patient's median survival time reached 10.4 months.
based on this excellent clinical data, the FDA granted it fast-track eligibility and agreed to allow Arnold Pharmaceuticals to declare the NDA in advance with the results of THE ORR's mid-term analysis.
in addition, animal test data show that Buparlisib has great potential for cancer treatment for PD-1 drugs without response or PD-1 tolerance.
can be seen through the ClinicalTrials.gov website (international authoritative clinical trial registry) website, Arnaud Buparlisib Phase 3 clinical study has been launched (registration number: NCT04338399).
the study, which will recruit nearly 500 patients, will assess the effectiveness of Buparlisib's combination of yew alcohol and yew alcohol alone in treating stubborn, recurrent, or metastatic head and neck cancer, and patients participating in Phase 3 clinical trials will include patients who have failed treatment with platinum chemotherapy or PD-1.
head and neck cancer is the sixth most common type of cancer in the world, with more than 550,000 cases and more than 300,000 deaths worldwide each year, more than half of whom are diagnosed with locally advanced tumors.
, there are 176,000 patients with head and neck cancer in China.
, although the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved PD-1 as a treatment for stubborn, recurrent or metastatic head and neck cancer, both listed PD-1 varieties have a response rate of less than 20%.
there are still a large number of unmet medical needs in the treatment of PD-1 drugs for non-response and tolerable head and neck cancer.
based on ideal data previously obtained from Buparlisib's global Phase 2 clinical practice, as well as excellent data in PD-1 non-response and tolerable mouse tumor therapy, this Phase 3 clinical study included patients who failed to be treated with platinum chemotherapy or PD-1.
in the future, Arnaud Buparlisib is expected to fill the gap in the treatment of patients with PD-1 drug non-response and tolerance for head and neck cancer.
We also wish this product a smooth development in subsequent clinical development, and benefit more patients as soon as possible.
References: I. Argirion et al., Temporal Changes in Head and Neck and Cancer Happen in Thailand Suggest Change Oropharynge Eith In The Region. J Glob Oncol 5, 1-11 (2019) s2. Chen et al., Cancer Statistics in China, 2015. CA Cancer J Clin 66, 115-132 (2016).