Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DS-1001b, AB-218
Safusidenib · 4 trials · 17 indications
PFS, defined as time from date of randomization to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR or death from any cause, whichever occurs earlier
calculate Percentage and numbers of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed by CTCAE 5.0
PFS is defined as the time from randomization to the date of the first documented disease progression assessed by BICR per RANO 2.0 or death (by any cause in the absence of disease progression).
ORR defined as the proportion of participants with the confirmed best overall response of Complete Response (CR), Partial Response (PR) or Minor Response (MR) per modified RANO 2.0, assessed by BICR
progression-free survival at 12 months measured by central review of MRI
| Arm | Type | Description |
|---|---|---|
| Safusidenib | EXPERIMENTAL | Safusidenib 250 mg BID |
| Placebo | PLACEBO_COMPARATOR | Placebo BID |
| safusidenib 125mg bid (part 1) | EXPERIMENTAL | safusidenib 125mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity. |
| safusidenib 250mg bid (part 1) | EXPERIMENTAL | safusidenib 250mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity. |
| safusidenib 500mg qd (part 1) | EXPERIMENTAL | safusidenib 500mg qd administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity. |
| safusidenib 375mg bid (part 1) | EXPERIMENTAL | safusidenib 375mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity. |
| safusidenib 500mg bid (part 1) | EXPERIMENTAL | safusidenib 500mg bid administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with safusidenib until disease progression or development of other unacceptable toxicity. |
| safusidenib 250mg bid (Part 2) | EXPERIMENTAL | safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment until disease progression or another reason for discontinuation occurs. |
| placebo (Part 2) | PLACEBO_COMPARATOR | Placebo administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with placebo until disease progression or another reason for discontinuation occurs. |
| safusidenib 250mg bid (Part 3) | EXPERIMENTAL | safusidenib administered continuously as dosed single agent orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment until disease progression or another reason for discontinuation occurs. |
| Safusidenib arm | EXPERIMENTAL | All participants will receive safusidenib (250 mg BID) until progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Safusidenib | DRUG | Safusidenib administered twice daily as a single agent dosed orally on Days 1 through 28 of a 28-day cycle. Participants may continue treatment until disease progression or another reason for discontinuation occurs. |
| Placebo | DRUG | Placebo administered twice daily as a single agent dosed orally on Days 1 through 28 of a 28-day cycle. Participants may continue treatment with placebo until disease progression or another reason for discontinuation occurs. |
Key Inclusion Criteria: * Expected survival of ≥12 months. * At least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days (or at least 28 days if biopsy only and postoperative changes have resolved per BIC...
Safusidenib is an investigational oral medicine being studied for IDH1-mutant gliomas, including grade 2 astrocytoma and oligodendroglioma, grade 3 oligodendroglioma and astrocytoma, and higher-grade IDH1-mutant astrocytoma. It is also being tested in patients whose IDH1-mutant glioma progressed after vorasidenib. It is not approved for any use.
Safusidenib targets mutant IDH1, the isocitrate dehydrogenase 1 enzyme. It is a small-molecule IDH1 inhibitor, meaning it is designed to block the abnormal enzyme activity produced by IDH1 mutations in glioma cells. Because the trials select patients by IDH1 mutation status, Safusidenib is a biomarker-selected therapy.
Safusidenib is being developed by Nuvation Bio Inc., a clinical-stage oncology company that trades on the New York Stock Exchange under the ticker NUVB. Nuvation Bio is running the Safusidenib glioma program, including the Phase 3 SIGMA study and additional Phase 2 studies in IDH1-mutant glioma.
Safusidenib is in Phase 3 clinical development for IDH1-mutant glioma. The Phase 3 SIGMA trial, NCT05303519, is currently recruiting, and a second Phase 3 study, NCT07712757, in grade 2 IDH1-mutant glioma is not yet recruiting. Safusidenib is investigational and has not been approved by the FDA.
Safusidenib is being studied in four registered trials. NCT05303519, the Phase 3 SIGMA maintenance study, is recruiting with 365 participants across the United States, Australia, and China. NCT07712757 is a Phase 3 study in grade 2 IDH1-mutant glioma, and NCT07832123 and NCT07703436 are Phase 2 studies in newly diagnosed grade 3 glioma and in patients who progressed after vorasidenib, respectively.
No. Safusidenib is an investigational drug and has not been approved by the FDA. It has received FDA Fast Track designation, which is intended to expedite review of drugs for serious conditions with unmet medical need. It remains in clinical development, with Phase 3 trials ongoing and additional studies planned.