Approval Probability
TA Base Rate
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Also known as AN2025
Buparlisib & Paclitaxel · 2 trials · 2 indications
To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC
Number of participants with Dose Limiting Toxicities (DLTs)
The safety profile will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
| 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. |
| DLT Observation Period I - AN2025 and Atezolizumab | EXPERIMENTAL | During the DLT Observation I, patients will be treated with AN2025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN2025 is 50 mg. If tolerated, then a subsequent cohort will escalate to 100 mg. A dose de-escalation cohort to 80 mg may occur if the 100 mg is not well tolerated. The dose of Atezolizumab will remain constant at 1200 mg every 3 weeks (Q3W) for each dose level of AN2025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. |
| DLT Observation Period II - AN0025 and Atezolizumab | EXPERIMENTAL | During the DLT Observation II, patients will be treated with AN0025 and Atezolizumab until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The starting dose of AN0025 is 250 mg. If tolerated, then a subsequent cohort will escalate to 500 mg. If 250 mg AN0025 is not tolerated, de-escalate to 125 mg. The dose of Atezolizumab will remain constant at 1200 mg Q3W for each dose level of AN0025 and in each cohort. Atezolizumab is administered intravenously over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. |
| DLT Observation Period III - AN2025, AN0025 and Atezolizumab | EXPERIMENTAL | The DLT Observation III will be started after safety data review by the investigators and the sponsor of the double combination treatments in Observations I and II. Patients enrolled in Observation III will start with the recommended dose of AN0025 from Observation II, 1200 mg Atezolizumab, and AN2025 will start from 50 mg QD. Patients will be treated with all three study drugs until the patient experiences disease progression, unacceptable toxicity or withdraws consent. The dose of Atezolizumab will be the same (i.e., 1200 mg Q3W) regardless of dose levels of AN2025 and cohorts. Atezolizumab is administered intravenously over 60 minutes every three weeks. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes. The dose of AN0025 as determined in Observation II will remain constant for each dose level of AN2025 and each cohort, unless the investigators and the sponsor determine that the toxicity comes from the AN0025 + Atezolizumab combination. |
| Name | Type | Description |
|---|---|---|
| Buparlisib & Paclitaxel | DRUG | Investigation drug plus paclitaxel |
| AN2025 | DRUG | oral administration |
| AN0025 | DRUG | oral administration |
| Atezolizumab 1200 mg in 20 ML Injection | DRUG | infusion |
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.