Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP 798 · 2 trials · 2 indications
Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria \[Cheson et al, 1999\]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by \>75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; \>=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.
Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUCinf was estimated using the linear trapezoidal rule.
Maximum observed concentration following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
| Arm | Type | Description |
|---|---|---|
| ABP 798 | EXPERIMENTAL | ABP 798 was administered at a dose of 375 mg/m\^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20. |
| Rituximab | ACTIVE_COMPARATOR | Rituximab was administered at a dose of 375 mg/m\^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20. |
| ABP 798 / ABP 798 | EXPERIMENTAL | Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart. |
| Rituximab (US) / ABP 798 | ACTIVE_COMPARATOR | Participants received rituximab (United States \[US\] formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart. |
| Rituximab (EU) / Rituximab (EU) | ACTIVE_COMPARATOR | Participants received rituximab (European Union \[EU\] formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart. |
| Name | Type | Description |
|---|---|---|
| ABP 798 | BIOLOGICAL | ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy. |
| Rituximab | BIOLOGICAL | Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy. |
| Rituximab (US) | DRUG | Supplied as a 10 mg/mL liquid concentrate for IV administration. |
| Rituximab (EU) | DRUG | Supplied as a 10 mg/mL liquid concentrate for IV administration. |
Inclusion Criteria: * Males and females 18 years of age and older * Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization * Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging ...
ABP 798 is an investigational small molecule being developed for rheumatoid arthritis and non-Hodgkin lymphoma. It is being studied as a potential treatment for these conditions, though it is not yet approved and remains in clinical development.
ABP 798 is a small molecule, but its specific molecular target has not been disclosed. It is being studied in comparison to rituximab, which targets CD20, but ABP 798's own mechanism of action is not specified.
ABP 798 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker AMGN. Amgen is conducting clinical trials to evaluate the safety and efficacy of ABP 798 in treating rheumatoid arthritis and non-Hodgkin lymphoma.
ABP 798 is in Phase 3 clinical development. Two Phase 3 trials have been completed, one in non-Hodgkin lymphoma and one in rheumatoid arthritis. The drug is investigational and has not been approved by regulatory authorities.
ABP 798 has completed two Phase 3 trials. NCT02747043 studied ABP 798 in non-Hodgkin lymphoma with 256 participants, and NCT02792699 studied it in rheumatoid arthritis with 311 participants. Both trials were randomized, double-blind, and active-controlled, comparing ABP 798 to rituximab.
ABP 798 is not the same as rituximab, but it is being studied as a potential biosimilar to rituximab. In clinical trials, ABP 798 is compared directly to rituximab to assess whether it is safe and effective in treating non-Hodgkin lymphoma and rheumatoid arthritis.