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 being developed for the treatment of rheumatoid arthritis and non-Hodgkin lymphoma. It is a proposed biosimilar to rituximab, studied in patients with moderate to severe rheumatoid arthritis and in patients with non-Hodgkin lymphoma. Amgen Inc. is developing the asset, which has completed Phase 3 clinical testing.
ABP 798 targets CD20, a protein found on the surface of B cells. By binding to CD20, the drug is designed to deplete B cells, the same mechanism of action as the reference product rituximab. This CD20-directed approach underlies its investigation in both autoimmune and B-cell lymphoma settings.
ABP 798 is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is advancing the candidate as a proposed biosimilar to rituximab. The program has completed Phase 3 development across rheumatoid arthritis and non-Hodgkin lymphoma indications.
ABP 798 has completed Phase 3 clinical development. It is an investigational biosimilar candidate and has not been approved by the FDA. Two Phase 3 studies have been completed, one in rheumatoid arthritis and one in non-Hodgkin lymphoma, comparing the drug to rituximab.
ABP 798 has been studied in two completed Phase 3 trials. NCT02792699 evaluated ABP 798 versus rituximab in moderate to severe rheumatoid arthritis with 311 patients. NCT02747043 evaluated ABP 798 versus rituximab in non-Hodgkin lymphoma with 256 patients. Both were randomized, double-blind, and active-controlled studies.
ABP 798 is not rituximab; it is a proposed biosimilar to rituximab developed by Amgen. A biosimilar is designed to be highly similar to an approved reference biologic, in this case rituximab. ABP 798 has been compared directly against rituximab in Phase 3 trials in rheumatoid arthritis and non-Hodgkin lymphoma.