Drug Name: BuparlisibCAS No.: 944396-07-0
All 483 patients participated in the worldwide Phase III clinical study (BURAN) of Buparlisib (AN2025) together with a drug called for the care of persistent or metastatic squamous cell carcinoma of the head and neck (HNSCC) by Arnold Pharmaceuticals, an Adlai Nortye company, on November 17, 2023. 70% of participants were from Europe and the United States, while 30% were from Asia-Pacific. The trial included individuals at more than 180 study centers in 18 major markets in North, Europe, Asia, and South America.
Phase III clinical investigation comparing Buparlisib plus paclitaxel versus paclitaxel alone for the treatment of persistent or advanced squamous cell cancer of the head and neck. Randomized, open, multicenter study. In recurring or recurrent squamous cell cancer of the head and neck carcinoma, this is the first globally multicenter Phase III clinical study involving a PI3K inhibitor.
The BURAN study is a randomized, unblinded, clinical Phase III study designed to evaluate the therapeutic efficacy of once-weekly paclitaxel in combination with once-daily AN2025 versus once-weekly paclitaxel alone in patients with the following refractory, recurrent, or metastatic squamous head and neck cancers:
1) Previous anti-PD-(L)1 monotherapy;
2) had anti-PD-(L)1 therapy in combination with platinum-based chemotherapy; or
3) sequential therapy following anti-PD-(L)1, either before or after platinum-based chemotherapy.
AN2025 is an extensively studied drug candidate for which Novartis has separately sponsored 40 clinical trials enrolling more than 4,200 patients across multiple cancer types. In one of these Phase II clinical trials, AN2025 in combination with paclitaxel was shown to provide patients with longer median overall survival and significantly improved median progression-free survival and objective remission rates compared to controls in the treatment of recurrent or metastatic squamous head and neck cancer treated with platinum-based chemotherapy.In July 2016, the FDA granted fast track status to AN2025 for the treatment of recurrent or metastatic head and neck cancer during or after platinum-based treatment that recurrent or metastatic squamous head and neck cancer that presents. Following the Phase III interim analysis and based on the resulting ORR data, Arnold Pharma expects to submit an NDA application to the FDA seeking fast-track approval in the first half of 2025, followed by further marketing approval applications to the State Drug Administration, the European Medicines Agency, the Japan Pharmaceuticals and Medical Devices Consolidation Agency, and other regulatory authorities.
Phase III : Head and neck cancer
Phase II: bladder cancer; breast cancer; chronic lymphocytic leukemia; hematologic malignancies; non-Hodgkin's lymphoma; thyroid cancer; ureteral tumors; urethral cancer
Phase I/II: Colorectal Cancer
Phase I: Solid Tumors
Indications for Termination of Clinical Studies: Basal Cell Carcinoma; Central Nervous System Cancer; Endometrial Cancer; Gastrointestinal Mesenchymal Tumor; Glioblastoma; Malignant Melanoma; Esophageal Cancer; Prostate Cancer; Renal Cell Carcinoma; Thymoma