Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PNT2258 · 3 trials · 6 indications
The proportion of patients with complete response (CR/complete metabolic response \[CMR\]) or partial response (PR/partial metabolic response \[PMR\]) according to the revised 2014 International Working Group (IWG) criteria for lymphoma (Cheson 2014)
Safety and tolerability of PNT2258 and the determination of dose-limiting toxicities (DLTs) and the recommended Phase 2 dose
| Arm | Type | Description |
|---|---|---|
| PNT2258 | EXPERIMENTAL | PNT2258 will be administered at 120 mg/m2 on days 1-5 of a 21-day cycle. Treatment may continue unless there is disease progression or the occurrence of unacceptable toxicity for a total of 8 "induction" cycles of therapy. Subjects with CR/CMR, PR/PMR or SD/NMR at the end-of-cycle 8 scan then receive ongoing PNT2258 therapy at a dose of 100 mg/m2 on days 1-4 of a 28 day cycle until progressive disease, the occurrence of unacceptable toxicity, non-compliance, voluntary withdrawal or if in the opinion of the investigator the subject is no longer benefiting from exposure to PNT2258. |
| Name | Type | Description |
|---|---|---|
| PNT2258 | DRUG | - |
Inclusion Criteria: Histologically confirmed diffuse large B-cell lymphoma that is refractory to prior therapy or relapsed after prior therapy. FDG PET-CT (disease) positive baseline scan with measurable disease. The patient must have received prior therapy that included: * CD20-targeted therapy...
PNT2258 is an investigational small molecule being studied for the treatment of cancer, including lymphoma, diffuse large B-cell lymphoma, and non-Hodgkin's lymphoma. It has been evaluated in patients with advanced solid tumors, relapsed or refractory non-Hodgkin's lymphoma, and relapsed or refractory diffuse large B-cell lymphoma.
PNT2258 is being developed by GSK plc, which trades under the ticker symbol GSK. The drug is an investigational small molecule in the oncology therapeutic area, and it has not yet received regulatory approval.
PNT2258 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that is not FDA approved. The most advanced completed trial was a Phase 2 study in patients with relapsed or refractory diffuse large B-cell lymphoma.
PNT2258 has been studied in three completed clinical trials: NCT01191775, a Phase 1 study in advanced solid tumors with 22 participants; NCT01733238, a Phase 2 study in relapsed or refractory non-Hodgkin's lymphoma with 13 participants; and NCT02226965, a Phase 2 study in relapsed or refractory diffuse large B-cell lymphoma with 45 participants.
PNT2258 is the drug studied in the Wolverine trial, which is the clinical trial NCT02226965 for patients with relapsed or refractory diffuse large B-cell lymphoma. The trial enrolled 45 participants in the United States and Puerto Rico.