Retacrit(R) Demonstrates Efficacy And Safety In Chemotherapy-Induced Anaemia

Main Category: Cancer / Oncology
Also Included In: Blood / Hematology;  Clinical Trials / Drug Trials;  Lymphoma / Leukemia / Myeloma
Article Date: 13 Sep 2008 - 13:00 PDT

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Hospira (NYSE: HSP), the world leader in generic injectable pharmaceuticals, presented new data showing Retacrit® (epoetin zeta) is an effective treatment for chemotherapy-induced anaemia,1 with an acceptable safety and tolerability profile.2 Results from the Phase III trial were presented at the European Society for Medical Oncology (ESMO) congress.

Retacrit is a biosimilar erythropoietin approved in Europe3 for subcutaneous administration in the treatment of anaemia associated with chemotherapy. Efficacy, safety and tolerability in this indication were evaluated from an open-label Phase III trial involving 216 patients with solid tumours, malignant lymphoma or multiple myeloma who were undergoing chemotherapy.

"This study confirms that treatment with Retacrit has real benefits for cancer patients with anaemia, a common side-effect of chemotherapy. The data showed a high haemoglobin response rate, which means a reduced need for blood transfusions during treatment and an improvement in patients' quality of life", commented principal study investigator Valentina Tzekova, University Hospital Queen Joanna, Sofia, Bulgaria.

Other results from the efficacy data showed that 70.8% of patients treated with Retacrit had a haemoglobin (Hb) response of ≥2 g/dL within 8 weeks. The mean Hb level was 10.6 g/dL at week 12, with 81% of patients remaining transfusion free during this 12-week study period.1 Poster 906P. Tzekova V et al. Epoetin zeta: efficacy data from an open-label, Phase III trial in patients with chemotherapy-induced anaemia. Session: Poster presentation. The mean increase in Hb across the whole intent-to-treat (ITT) study population was 1.8 g/dL at week 12, which is comparable with response rates seen in other studies of epoetin alfa and Retacrit.

Analysis of the safety data showed that, in almost all cases, patients and investigators reported tolerability as good or excellent. Of patients treated with Retacrit, 4.2% had clinically significant thrombotic events during the first 12 weeks of treatment, which was comparable with data presented in a recent meta analysis of erythropoietins by Bohlius et al where the median incidence was 4.5%.4 Additionally, no patient developed anti-erythropoietin antibodies during the study.2 Poster 907P. Mihaylov G. Epoetin zeta: safety data from an open-label, Phase III trial in patients with chemotherapy-induced anaemia. Session: Poster presentation.

"Hospira is committed to providing effective and well-tolerated treatments to help reduce healthcare costs, which in turn will allow more patients to be treated with potentially life-saving medications", said George Blackledge, Global Director of Clinical Operations, Research & Development, Hospira.

About the Study

This open-label Phase III trial involved 216 patients with solid tumours, malignant lymphoma or multiple myeloma who were undergoing chemotherapy and had pre-existing anaemia (defined as Hb <10 g/dL at screening) and who were at risk of blood transfusion. Retacrit was administered subcutaneously, 1-3 times weekly for 12 weeks.

Haemoglobin response: This was defined as an increase in Hb ≥1 g/dL or in reticulocyte count ≥40 000 cells/μL.

Intent-to-treat (ITT) population: Statistical analyses were performed on the ITT population, which comprised all patients who started therapy, and the per-protocol (PP) population, which included all patients without major protocol violations. Missing data were imputed using last observation carried forward (LOCF) methods.

About Retacrit

Retacrit is a biosimilar erythropoietin approved in Europe3 for the treatment of anaemia associated with chemotherapy (administered subcutaneously) and chronic kidney disease (administered intravenously). Approval was granted on the basis of strong safety and efficacy data, as well as compliance with extensive quality, clinical and non-clinical guidelines. Retacrit has been launched in several European countries including Germany, Austria, the UK, Ireland, Greece, Sweden, Norway and Portugal, and is manufactured and packaged in Germany using advanced technology and following Good Manufacturing Practice (GMP) standards.

Biosimilars that are licensed for use in the EU are high-quality, cost-effective alternatives to proprietary biopharmaceuticals. With a growing number of patents for biopharmaceuticals expiring, Hospira is expanding its competencies to develop, manufacture and market biosimilars in order to meet future demand for lower-cost alternatives.

About Hospira

Hospira is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Illinois, United States, and has more than 14,000 employees. The head office for Hospira in Europe, Middle East and Africa is in Leamington Spa, UK. Learn more about Hospira at http://www.hospira.com

References

1. Tzekova V, Mihaylov G, Koytchev R, Epoetin zeta: efficacy data from an open-label, Phase III trial in patients with chemotherapy-induced anaemia. 33rd European Society of Medical Oncology (ESMO) Congress; 12-16 September 2008; Stockholm, Sweden. Poster 906P.

2. Mihaylov G, Tzekova V, Koytchev R. Epoetin zeta: safety data from an open-label, Phase III trial in patients with chemotherapy-induced anaemia. 33rd European Society of Medical Oncology (ESMO) Congress; 12-16 September 2008; Stockholm, Sweden. Poster 907P.

3. European Medicines Agency (EMEA) European Public Assessment Report: Retacrit®. Available at http://www.emea.europa.eu. Accessed September 2008.

4. Bohlius J, Wilson J, Seidenfeld J, et al. Recombinant human erythropoietins and cancer patients: updated meta-analysis of 57 studies including 9353 patients. J Natl Cancer Inst 2006; 98:708-714.

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