Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DRL_RI · 2 trials · 2 indications
Best Overall Response Rate (BORR) is defined as the proportion of participants in each treatment group that achieved a best overall response of either Complete response (CR), unconfirmed Complete response (CRu) or Partial response (PR), up to Month 7 (Week 28) based on central radiology review in accordance with the Cheson, 1999 response criteria for Non-Hodgkin's Lymphomas. As per Cheson 1999, response criteria for target lesions and assessed by radiology: Complete response (CR): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with confirmed Bone marrow normalization; unconfirmed Complete response (CRu): All lesions with a longest diameter should be regressed to normal size (≤ 15 mm) or short axis regressed to ≤ 10 mm with non-confirmed Bone marrow normalization; Partial Response (PR): ≥ 50 % decrease of sum of products of diameter(SPD) of all the target lesions; Overall Response (OR)=CR+CRu+PR.
PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose.
PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose.
PK samples were collected pre-infusion; 3 hours post infusion; EOI; and at 1, 6, 24, 48, 168 hours post End of Infusion. A PK sample at 336 hours post EOI were also to be collected after the second dose
| Arm | Type | Description |
|---|---|---|
| Arm A: DRL_RI | EXPERIMENTAL | DRL\_RI (rituximab-Dr. Reddy's Lab) for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Weeks 12, 20, 28 and 36 |
| Arm B: MabThera® | ACTIVE_COMPARATOR | MabThera® for infusion 375 mg/m2 administered via IV infusion on Days 1, 8, 15, 22 and Week 12, 20, 28 and 36. |
| DRL_RI | EXPERIMENTAL | - |
| Rituxan | ACTIVE_COMPARATOR | - |
| MabThera | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DRL_RI (Proposed rituximab biosimilar) | BIOLOGICAL | Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion |
| MabThera® | OTHER | Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion |
| DRL_RI | BIOLOGICAL | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
| Rituxan | BIOLOGICAL | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
| MabThera | BIOLOGICAL | Two 1000 mg intravenous infusions, one each on Day 1 and Day 15 |
Inclusion Criteria: 1. Subject is Male or female subjects aged ≥18 years of age. 2. Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive. 3. Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1. 4. Subject has Low tumor burden follicular lymphoma as per G...
DRL_RI is an investigational monoclonal antibody being studied for use in rheumatoid arthritis and follicular lymphoma. It is being developed as a proposed biosimilar to rituximab, and clinical trials have evaluated it in patients with moderate to severe rheumatoid arthritis and in patients with follicular lymphoma.
DRL_RI targets CD20, a protein found on the surface of B cells. By binding to CD20, the antibody is designed to deplete B cells, which are involved in the inflammation of rheumatoid arthritis and the growth of follicular lymphoma. This mechanism is shared with the reference product rituximab.
DRL_RI is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol RDY. The company is conducting clinical trials to evaluate the drug as a proposed biosimilar to rituximab.
DRL_RI has completed a Phase 3 clinical trial in follicular lymphoma, and it has also completed a Phase 1 trial in rheumatoid arthritis. The drug is investigational and not yet approved by regulatory authorities. It remains in clinical development as a proposed biosimilar.
DRL_RI has been studied in two completed clinical trials. NCT02296775 was a Phase 1 study in patients with moderate to severe rheumatoid arthritis, enrolling 276 participants in India and Ukraine. NCT03976102 was a Phase 3 study in follicular lymphoma, enrolling 317 participants in the United States.
DRL_RI is a proposed biosimilar to rituximab, which is marketed as MabThera. It is designed to be highly similar to the reference product, but it is not identical. Clinical trials have compared DRL_RI with MabThera to evaluate their pharmacokinetics, efficacy, safety, and immunogenicity.