Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as no brand name available
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 developed by Novartis AG (ticker NVS). It is being studied in follicular lymphoma, indolent B-cell non-Hodgkin's lymphoma, and rheumatoid arthritis. It is a biosimilar candidate referencing rituximab, a CD20-directed therapy, and has been evaluated in Phase 3 clinical development.
GP2013 is being developed for follicular lymphoma, indolent B-cell non-Hodgkin's lymphoma, and rheumatoid arthritis. The Phase 3 ASSIST_FL trial studied it in patients with previously untreated, advanced stage follicular lymphoma. A separate trial evaluated it in rheumatoid arthritis patients who were refractory to or intolerant of standard therapy.
GP2013 targets CD20, a protein found on the surface of B cells. As a monoclonal antibody, it binds CD20 and is designed to deplete B cells, which is the mechanism underlying its investigation in B-cell lymphomas and in rheumatoid arthritis, where B cells contribute to disease activity.
GP2013 is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical trials evaluating GP2013 across follicular lymphoma, indolent B-cell non-Hodgkin's lymphoma, and rheumatoid arthritis.
GP2013 has been evaluated in Phase 3 clinical development. Its Phase 3 trial, ASSIST_FL, was completed and enrolled 629 patients with previously untreated, advanced stage follicular lymphoma. GP2013 is investigational and is not described as approved by the FDA.
GP2013 has been studied in three completed trials. NCT01419665 was a Phase 3 trial in previously untreated advanced stage follicular lymphoma with 629 patients. NCT01274182 was a Phase 1 trial in rheumatoid arthritis with 312 patients. NCT01933516 was a Phase 1 trial in Japanese patients with indolent B-cell non-Hodgkin's lymphoma.