Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GP2013 · 3 trials · 3 indications
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
Adverse events, laboratory abnormalities
Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169
| Arm | Type | Description |
|---|---|---|
| GP2013 | EXPERIMENTAL | Type: Biological/Vaccine |
| rituximab | ACTIVE_COMPARATOR | Type: Biological/Vaccine |
| MabThera | ACTIVE_COMPARATOR | - |
| Rituxan | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GP2013 | BIOLOGICAL | Type: Biological/Vaccine |
| rituximab | BIOLOGICAL | Type: Biological/Vaccine |
| MabThera | BIOLOGICAL | 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15) |
| Rituxan | BIOLOGICAL | 1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15) |
Inclusion Criteria: * Patient with previously untreated advanced stage, CD20-positive FL * Patient with ECOG performance status 0, 1 or 2. Exclusion Criteria: * Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a * Patient who has previously received any prior th...
GP2013 is an investigational monoclonal antibody being developed for the treatment of Follicular Lymphoma, Indolent B-cell Non-Hodgkin's Lymphoma, and Rheumatoid Arthritis. It is currently in Phase 3 clinical development for these indications.
GP2013 is being developed by Novartis AG, which trades under the ticker symbol NVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain lymphomas and rheumatoid arthritis.
GP2013 is in Phase 3 clinical development. It has completed a Phase 3 trial in patients with previously untreated, advanced stage follicular lymphoma, as well as earlier phase trials in rheumatoid arthritis and indolent B-cell non-Hodgkin's lymphoma.
GP2013 has completed three clinical trials: NCT01274182 in rheumatoid arthritis, NCT01419665 in follicular lymphoma, and NCT01933516 in indolent B-cell non-Hodgkin's lymphoma. All trials are completed, with the follicular lymphoma trial being a Phase 3 study.
GP2013 is not FDA approved. It is an investigational drug still in clinical development, having completed Phase 3 trials but not yet submitted for regulatory approval.
GP2013 is a monoclonal antibody that targets CD20, a protein found on the surface of B-cells. By binding to CD20, it is designed to help treat B-cell related conditions such as follicular lymphoma and rheumatoid arthritis.