Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Umbralisib · 2 trials · 5 indications
ORR for MZL=percentage of participants with complete response (CR)/partial response (PR). ORR for WM=CR/PR/very good partial response (VGPR)/minor response (MR). Response assessed per revised Lugano Classification for MZL \&per IWWM for WM participants. Per Lugano criteria CR=complete disappearance of all evidence of disease \& disease-related symptoms. PR=regression of measurable disease \& no new disease sites. Regression=≥50% decrease in the sum of the products of the diameters (SPD) of index lesions, with no increase in size of other lymph nodes/liver/spleen.Per IWWM criteria CR=disappearance of serum monoclonal immunoglobulin M (IgM) protein by immunofixation with a normal serum IgM level. VGPR=reduction of monoclonal IgM protein \>90% from baseline. PR=reduction of monoclonal IgM protein between 50-90% from baseline with regression of measurable disease. Regression defined in similar manner as Lugano Classification. MR=reduction of monoclonal IgM protein \>25% but \<50% from baseline.
DOR is defined as the time from documentation of a response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
| Arm | Type | Description |
|---|---|---|
| Marginal Zone Lymphoma (MZL): Umbralisib | EXPERIMENTAL | Participants with non-follicular indolent non-Hodgkin's lymphoma (iNHL) with MZL as the histology type received umbralisib, 800 milligrams (mg), orally, once daily (QD), until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first. |
| Waldenstrom's Macroglobulinemia (WM): Umbralisib | EXPERIMENTAL | Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first. |
| TG-1501 + Ublituximab + Umbralisib | EXPERIMENTAL | Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals |
| Name | Type | Description |
|---|---|---|
| Umbralisib | DRUG | Oral Daily Dose |
| ublituximab | BIOLOGICAL | IV anti-CD20 monoclonal antibody |
| TG-1501 | BIOLOGICAL | IV immunotherapy for cancer |
Inclusion Criteria: * Confirmed diagnosis of Waldenstroms Macroglobulinemia * Relapsed or refractory after at least one prior treatment regimen * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: * Any major surgery, chemotherapy or immunotherapy within the last 21 day...
Umbralisib is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma. It is also being evaluated in Richter Syndrome and other non-follicular indolent non-Hodgkin lymphomas. The drug is in clinical development and is not yet approved by the FDA.
Umbralisib is a PI3K inhibitor, as indicated by its '-lisib' suffix, which denotes its target class. It is being studied in oncology for its potential to treat certain blood cancers, including Chronic Lymphocytic Leukemia and Marginal Zone Lymphoma.
Umbralisib is being developed by TG Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TGTX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain hematologic malignancies.
Umbralisib has completed Phase 1 and Phase 2 clinical trials. A Phase 1 study evaluated the drug in combination with ublituximab in patients with relapsed or refractory Chronic Lymphocytic Leukemia or Richter's Transformation. A separate Phase 2 study assessed its efficacy and safety in Marginal Zone Lymphoma and other indolent non-Hodgkin lymphomas.
Umbralisib has been studied in two completed clinical trials. NCT02535286 was a Phase 1 study of immunotherapy combined with ublituximab and umbralisib in patients with relapsed or refractory CLL or Richter's Transformation. NCT03364231 was a Phase 2 study evaluating umbralisib in participants with Marginal Zone Lymphoma and other non-follicular indolent non-Hodgkin lymphomas.
Umbralisib is the drug name used in clinical trials, and it may also be referred to by its chemical salt form, umbralisib tosylate. The clinical studies NCT02535286 and NCT03364231 use the name umbralisib, and the drug is being developed by TG Therapeutics for the treatment of certain B-cell malignancies.