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Buparlisib & Paclitaxel · 1 trial · 1 indication
To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC
| Arm | Type | Description |
|---|---|---|
| Buparlisib & Weekly Paclitaxel | EXPERIMENTAL | Drug: Patients will receive 100 mg (2 x 50 mg) buparlisib hard gel capsule administered orally, once daily starting on Day 1 of Treatment Cycle 1, Drug: Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason. |
| Weekly Paclitaxel | ACTIVE_COMPARATOR | Patients will receive weekly paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason. |
| Name | Type | Description |
|---|---|---|
| Buparlisib & Paclitaxel | DRUG | Investigation drug plus paclitaxel |
Inclusion Criteria: 1. Aged ≥18 years old. 2. Able to provide informed consent obtained before any trial related activities and according to local guidelines. 3. Patient has histologically and/or cytologically-confirmed HNSCC. 4. Patient has archival or new tumor tissue for the analysis of biomarke...
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Buparlisib & Paclitaxel is being developed for the treatment of head and neck cancer, specifically recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). It combines the small molecule buparlisib with paclitaxel chemotherapy and is being studied in patients 18 years and older.
Buparlisib targets the PI3K family of kinases, including PIK3CA, PIK3CB, PIK3CD, PIK3CG, PIK3R1, and PIK3R2. It acts as an inhibitor of these phosphoinositide 3-kinase subunits, which are part of the PI3K signaling pathway. Paclitaxel is a chemotherapy agent combined with buparlisib in this regimen.
Buparlisib & Paclitaxel is being developed by Adlai Nortye Ltd., which trades under the ticker ANL on the American Depositary Shares market. The company is advancing the combination in oncology, with a focus on head and neck cancer.
Buparlisib & Paclitaxel is in Phase 3 clinical development. It is an investigational combination and has not been approved by the FDA. The Phase 3 program includes one completed trial evaluating the combination in patients with recurrent or metastatic head and neck squamous cell carcinoma.
The BURAN Study, registered as NCT04338399, is a Phase 3 trial of buparlisib in patients with recurrent or metastatic HNSCC. It enrolled 487 patients across the United States, Argentina, Australia, Belgium, Canada, China, France, Germany, Hong Kong, Hungary, Italy, Japan, Poland, South Korea, Spain, Taiwan, and the United Kingdom. The trial is completed.
No, the Buparlisib & Paclitaxel Phase 3 program is not biomarker selected. The BURAN Study enrolled patients with recurrent or metastatic head and neck squamous cell carcinoma regardless of biomarker status, with a randomized, active-controlled design and 487 participants.