VAL-083 (Dianhydrogalactitol)
| Property | Information |
|---|---|
| Drug Name | VAL-083 (Dianhydrogalactitol) |
| FDA Approval | Approved in China for CML and lung cancer; not yet approved outside of China for GBM |
| Used for | Recurrent Glioblastoma Multiforme (GBM) with unmethylated MGMT promoter |
| Clinical Trial Phase | Phase 2 (ongoing evaluation in GBM AGILE for various GBM subtypes) |
| Clinical Trial Explanation | Not specified |
| Common Side Effects | Myelosuppression, including neutropenia and lymphopenia; some instances of serious adverse events possibly related to VAL-083 |
| OS without | Historical mOS for similar patient population using lomustine is 7.2 months |
| OS with | 8.0 months mOS observed in phase 2 trial for patients receiving treatment dose of 30 mg/m2/day |
| PFS without | Not specified |
| PFS with | Not fully established from available data |
| Usefulness Rating | Pending further clinical trials |
| Usefulness Explanation | Shows potential for treating recurrent GBM, especially in specific genetic profiles like unmethylated MGMT promoter. Comparative mOS suggests potential improvement over lomustine. |
| Toxicity Level | 3 |
| Toxicity Explanation | The most common adverse event reported is myelosuppression, including instances of neutropenia and lymphopenia. A few patients experienced serious adverse events possibly related to VAL-083, indicating a moderate toxicity profile. Ongoing monitoring and management of these side effects are essential to minimize risks to patients. |
From Ben Williams Book: VAL-083 represents an innovative approach to treating recurrent GBM, leveraging a unique mechanism of action that differs from other alkylating agents. Its effectiveness in patients with specific genetic markers, such as an unmethylated MGMT promoter, underscores the importance of targeted genetic testing in guiding GBM treatment. Further studies are crucial to confirm these preliminary findings and fully establish VAL-083's therapeutic potential and safety profile in GBM treatment.Property "Has original text" (as page type) with input value "VAL-083 represents an innovative approach to treating recurrent GBM, leveraging a unique mechanism of action that differs from other alkylating agents. Its effectiveness in patients with specific genetic markers, such as an unmethylated MGMT promoter, underscores the importance of targeted genetic testing in guiding GBM treatment. Further studies are crucial to confirm these preliminary findings and fully establish VAL-083's therapeutic potential and safety profile in GBM treatment." contains invalid characters or is incomplete and therefore can cause unexpected results during a query or annotation process.
