NorthWest Biotherapeutics Inc (NWBO)

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HyGro,

Should we all be excited about the fact that fifty GBM patients receiving DCVax-L are still alive? This is an earth-shattering record. The following are some answers from ChatGPT. Hopefully they are enlightening.

Here are three examples from ChatGPT which had primary endpoint changed after trial started.

The LUX-Lung 3 trial: This trial evaluated the efficacy and safety of afatinib in patients with advanced non-small cell lung cancer (NSCLC). The original primary endpoint was PFS, but it was later changed to OS after an interim analysis showed a significant improvement in OS with afatinib.

The AVANT trial: This trial evaluated the efficacy and safety of bevacizumab in patients with metastatic colorectal cancer. The original primary endpoint was disease-free survival (DFS), but it was later changed to OS after an interim analysis showed a significant improvement in OS with bevacizumab.

The SOLID-Tumor trial: This trial evaluated the efficacy and safety of tucatinib in patients with HER2-positive solid tumors. The original primary endpoint was PFS, but it was later changed to OS after an interim analysis showed a significant improvement in OS with tucatinib.

Here is the answer on OS and PFS from ChatGPT.

The choice between overall survival (OS) and progression-free survival (PFS) as a primary endpoint in a clinical trial depends on the specific context of the study, the disease being studied, and the treatment being evaluated. In some cases, OS may be a more appropriate endpoint, while in others, PFS may be more appropriate.

OS is generally considered the gold standard endpoint for evaluating the efficacy of cancer treatments. OS measures the time from the start of treatment to death from any cause. It provides a clear and objective measure of the treatment's impact on patient survival and is less subject to bias than other endpoints.

On the other hand, PFS measures the time from the start of treatment until disease progression or death from any cause. PFS is commonly used as an endpoint in clinical trials, particularly for cancers with a prolonged disease course or where the treatment is expected to delay disease progression. PFS may be a more sensitive endpoint than OS in these cases, as it can capture smaller changes in disease progression that may not translate into a survival benefit.

In summary, both OS and PFS have their advantages and disadvantages as primary endpoints in clinical trials. The choice between these endpoints depends on the specific context of the study and should be made based on a careful consideration of the disease being studied, the treatment being evaluated, and the goals of the study.