Four Studies Report Real-World Data on Biosimilar Rituximab, Truxima

The FDA recently approved biosimilar rituximab CT-P10, or Truxima. While the drug is not yet available in the United States, data are accruing for its use in Europe. During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, 4 groups of researchers reported on real-world data that support the use of the biosimilar in cancer care.
Kelly Davio
June 18, 2019
The FDA recently approved biosimilar rituximab CT-P10, or Truxima. While the drug is not yet available in the United States, data are accruing for its use in Europe. During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, 4 groups of researchers reported on real-world data that support the use of the biosimilar in cancer care.

Biosimilar Rituximab Did Not Negatively Impact Response to R-CHOP
In a presentation from a UK study, researchers said that using biosimilar rituximab did not have a negative impact on the effect of therapy with rituximab plus cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP).1

All patients treated for de novo stage II to stage IV diffuse large B-cell lymphoma (DLBCL) at a university hospital were identified from the center’s chemotherapy prescribing system, and a total of 70 patients were found to have completed R-CHOP using the biosimilar rituximab.

Patients received a median of 6 cycles of treatment (range, 1-6) and 6 doses of rituximab (range, 2-8). Fifty-eight patients received only the biosimilar, whereas 12 patients were switched from the reference to the biosimilar.

In total, 73% of patients achieved complete response (CR), 16% achieved partial response (PR), and 9% had progressive disease. Two patients died before response could be assessed. Six percent of patients changed to a different chemotherapy regimen, and all 6 achieved CR.

Using the biosimilar, write the authors, does not appear to adversely impact response to R-CHOP.

Local Study Finds That Biosimilar Creates Significant Savings
A second study from the United Kingdom, conducted among multiple centers in a National Health Service (NHS) trust, found that using the biosimilar rituximab produced significant cost savings.2

The study was conducted from 2017 to 2018 among 42 patients who received the biosimilar for B-cell malignancy, with or without chemotherapy. In total, 24 had DLBCL.

The biosimilar was well tolerated, and 90% of patients completed infusions without complications. Three patients had mild infusion reactions. Among patients with DLBCL, 33% achieved complete remission.

Additionally, the biosimilar is 10% less expensive to acquire than the reference for the NHS, with a price of £314.33 (US $399.63) versus £349.25 (US $444.02) per 100 mg. These savings can have a significant impact, say the authors, at the patient and societal levels.

Real-World Evidence Finds Biosimilar Effective
Researchers from the hematology clinic at a single center in Bulgaria reported on an assessment of the biosimilar in 51 patients with chronic lymphocytic leukemia (n = 21), Richter syndrome (n = 1), DLBCL (n = 16), mantle cell lymphoma (n = 4), small-cell lymphoma (n = 4), and marginal cell lymphoma (n = 4). Patients received the biosimilar together with their chemotherapy every 3 weeks.3

The biosimilar was first-line treatment in 34 patients, second-line treatment in 12, and third-line treatment in 5.

In total, 30 patients had completed treatment at the time of analysis. CR was achieved in 30.0% of patients and PR in 56.7%; 13.3% had stable disease, while progressive disease was observed in 1 patient. Grade 3 or 4 hematological toxicity was observed in 9.8% of patients, and infusion-related reactions were observed in 5.8% of patients.

According to the authors, the biosimilar is effective and did not have any unexpected adverse events.

Study in the EU 5 Finds High Proportion of Patients Achieve CR, PR With Biosimilar
Finally, researchers reported interim results from an ongoing study in the EU 5 (France, Germany, Italy, Spain, and the United Kingdom) among patients with DLBCL who were treated with biosimilar rituximab.4

The primary objective of the noninterventional study, which relies on medical records from consenting patients, is to describe the effectiveness of the biosimilar.

The interim analysis includes data from 151 UK and Spanish patients, with a median 8.9 months (interquartile range, 6.1-12.6) of observation. Patients are receiving the biosimilar as a first-line (91%), second-line (6%), or third-line (3%) agent.

In total, 70% of patients achieved CR, 23% achieved PR, 5% had no response or stable disease, and 2% had progressive disease.

Safety was evaluable in 128 patients, 92% of whom experienced AEs and 60% of whom had AEs of grade 3 or above. In total, 9% discontinued due to AEs.

These early results, say the authors, suggest a high proportion of patients with DLBCL treated with the biosimilar achieve CR or PR, similar to rates reported for the reference.

References
1. Cheesman S, Shah R, Lambert J, et al. Responses to R-CHOP chemotherapy incorporating biosimilar rituximab (Truxima) for the first line treatment of diffuse large B-cell lymphoma—initial experience at University College London Hospital. Presented at: the 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, the Netherlands. Abstract PF312.

2. Lo I, Bansal S, Arami S. The safety and efficacy of the biosimilar anti-CD20 antibody, Truxima, in hematological malignancy. Presented at: the 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, the Netherlands. Abstract PB2263.

3. Micheva I, Useir S, Gercheva L. Efficacy and safety of rituximab biosimilar Truxima in patients with chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. Presented at: the 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, the Netherlands. Abstract PB1912.

4. Bishton M, Turner D, Marshall S, et al. Real world clinical effectiveness and safety of CT-P10 in patients with diffuse large B-cell lymphoma: interim results from a European non-interventional post-authorization safety study. Presented at: the 24th European Hematology Association Congress; June 13-16, 2019; Amsterdam, the Netherlands. Abstract PF314.

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