Phase 3
N=317
Compare Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) With MabThera® in LTB Follicular Lymphoma
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03976102 ↗Enrolled (actual)
317
Serious AEs
13.7%
Results posted
Jan 2024
Primary outcome: Primary: Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma — 80.2; 79.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DRL_RI (Proposed rituximab biosimilar) (Biological); MabThera® (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dr. Reddy's Laboratories Limited
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Overall Response Rate (BORR) for Low Tumor Burden Follicular Lymphoma |
80.2; 79.4 | — |
| SECONDARY Overall Response Rate (ORR) |
62.3; 63.9; 75.3; 73.5 | — |
| SECONDARY Complete Response Rate |
32.7; 34.2 | — |
| SECONDARY Complete Response Rate as a Best Response |
34.0; 35.5 | — |
| SECONDARY Duration of Response (DOR) |
NA; NA | — |
| SECONDARY Progression-free Survival (PFS) |
NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
| SECONDARY Number of Participants With Adverse Events |
113; 103; 13; 18; 28; 32 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibody (ADA) |
2; 0; 2; 0; 1; 0 | — |
Summary
The primary objective of the current study is to demonstrate the equivalent efficacy of rituximab (DRL\_RI) and MabThera® in subjects with Low Tumor Burden Follicular Lymphoma (LTB-FL).
Also evaluated by Pharmacokinetic, safety, and immunogenicity assessment between a proposed biosimilar (DRL\_RI) and the RMP, as an component of clinical study program, and collectively providing the evidence of biosimilarity.
The study will compare the safety and efficacy of DRL\_RI vs MabThera in patients with Low Tumor Burden Follicular Lymphoma (LTB-FL). The primary objective is to establish comparative efficacy as measured by ORR up to week 28
Eligibility Criteria
Inclusion Criteria
- Subject is Male or female subjects aged ≥18 years of age.
- Subject is histologically confirmed, Grade 1-3a, previous ly untreated, CD20-pos itive.
- Subject has Ann Arbor Stage II to IV and ECOG status of 0 to 1.
- Subject has Low tumor burden follicular lymphoma as per Groupe d'Etude des Lymphomes Folliculaires (GELF) Criteria
- Subject has at least 1 measurable tumor mass in 2 dimensions, and the mass must be:
- Nodal lesion >15 mm in the longest dimension; or
- Noda l lesion >10 mm to he longest dimension; dimens ion and >10 mm in the shortest dimension; or
- Extra-nodal lesion with both long and short dimensions ≥10 mm.
- Subject has Life expectancy ≥3 months.
- If female subject, then subject should be non-pregnant, non-lactating.
Exclusion Criteria
- Subject with prior use of rituximab or any CD20 monoclonal antibody for any reason.
- Subjects with known hypersensitivity to rituximab or its excipients, or to proteins of murine or other foreign origin.
- Any prior therapy for follicular lymphoma (including but not limited to chemotherapy, radiotherapy) or subjects on chronic supra-substitutive doses of systemic gluco-corticosteriods.
- Subjects who, in the opinion of the Investigator, require additional concomitant treatment for lymphoma.
- Evidence of histologic transformation to high grade lymphoma or diffuse large B-cell lymphoma.
- Subjects with known sero-positivity for or history of active viral infection with human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) will be excluded. And if positive for hepatitis B core antibody or hepatitis C virus (HCV) antibody can only be enrolled if HBV - DNA level <20 IU/mL (or 112 copies/mL) and HCV - RNA is negative respectively by PCR test..
- Subjects who have received a live vaccine within last 3 months of the first administration of study drug.
- Subjects with history or presence of a medical condition or disease that in the Investigator's opinion would place the subject at an unacceptable risk for study participation.
- Participation in any clinical study or having taken any investigational therapy (within 2-months of the first dose of study drug.
- Women of childbearing potential who do not consent to use highly effective methods of birth control.
Data sourced from ClinicalTrials.gov (NCT03976102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.