Hospira Data on European Biosimilar Epoetin, Retacrit, Affirm Treatment Response, Tolerability in Management of Anemia Secondary to Chemotherapy
-- Post-marketing study, presented at ASCO, included more than 2,300 patients --
LAKE FOREST, Illinois, June 3, 2013 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, announced today results from a post-marketing study of the company's European biosimilar epoetin, Retacrit™. This prospective, observational study met the primary endpoint, as defined by hemoglobin treatment response, in the management of chemotherapy-induced anemia in adult patients with solid tumors, lymphomas and myelomas, regardless of chemotherapy cycle. Retacrit was well tolerated by patients in the study. Full results of the study, called ORHEO (place of biOsimilaRs in the therapeutic management of anemia secondary to chemotherapy in HEmatology and Oncology), were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 3 (Abstract 9564).
Retacrit, a recombinant human erythropoietin, or an "EPO biosimilar," was launched in Europe in early 2008. Retacrit is used to treat symptomatic anemia associated with chronic renal failure in adult and pediatric patients and anemia in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma.
Study Design
Patients with chemotherapy-induced anemia (Hb <110 g/L), greater than 18 years old, with solid tumors, lymphomas or myelomas and eligible for epoetin alfa treatment were included in the study. The primary endpoint was the rate of response (defined as an increase in Hb levels to 100 g/L or at least 10 g/L since inclusion visit, or reaching target Hb set at start of study, without any blood transfusions in the three weeks prior to measurement) at plus three months (M3). Other endpoints included rate of response at plus six months (M6) and safety endpoints.
Study Results
This European prospective, observational study included 2,310 patients with solid tumors, lymphomas or myelomas. The majority of patients (>80 percent) enrolled in this study achieved a pre-defined hemoglobin (Hb) response with Retacrit in a real-world clinical setting. Retacrit was well tolerated in this study with an overall rate of thrombotic events at 3.5 percent. In this observational study, no epoetin alfa biosimilar-related deaths were reported.[1]
"Patients in the study showed a very good rate of response to Retacrit and tolerated it well," said Dr. Elisabeth Luporsi-Gely, of ICL Alexis Vautrin, Vandoeuvre-les-Nancy, France, and one of the study's principal investigators. "This is the first post-marketing observation study conducted in France for a biosimilar, and the results reinforce why there is a growing acceptance of biosimilars. The introduction of biosimilars has offered new options for patients and has helped bring cost savings to the healthcare system."
In addition to the results from this study, several Hospira-related studies (view links below) were presented at the ASCO Annual Meeting, including:
- Young-Hyuck Im, Petro Odarchenko, Daniela Grecea, Dmitry Komov, et al: Double-blind, randomized, parallel group, phase III study to demonstrate equivalent efficacy and comparable safety of CT-P6 and trastuzumab, both in combination with paclitaxel, in patients with metastatic breast cancer (MBC) as first-line treatment; Presented at 2013 ASCO Annual Meeting
- Jean-Emmanuel Kurtz, Pierre-Louis Soubeyran, Mauricette Michallet, Elisabeth Luporsi-Gely ;Epoetin biosimilars in the management of chemotherapy-induced anemia in elderly patients: A subanalysis of the ORHEO study; Poster session presented at 2013 ASCO Annual Meeting
- Manuel Constenla, Jorge Aparicio, M.Auxiliadora Gomez, Cristina Gravalos Castro, Miriam Lopez-Gomez, Jose Luis Manzano, Maria Dolores Pineda, Juana Maria Cano, Isabel Sevilla, et al; Tolerability of raltitrexed when it is used in monotherapy and in combination with oxaliplatin (TOMOX) as advanced colorectal cancer treatment in normal clinical practice; Poster session presented at 2013 ASCO Annual Meeting
Hospira's second marketed biosimilar product is Nivestim™, a biosimilar version of filgrastim, a recombinant Granulocyte Colony-Stimulating Factor (G-CSF), used for a condition known as neutropenia in which the body makes too few infection-fighting white blood cells. Nivestim entered the European market in 2010 and the Australian market in 2011.
Hospira's broad biosimilars pipeline, including products it shares with South Korean partner Celltrion, is comprised of 11 products and is one of the largest in the industry. In 2012, Hospira filed for European approval of a biosimilar version of infliximab, a treatment for auto-immune diseases, including rheumatoid arthritis, Crohn's disease, ulcerative colitis and psoriasis. Hospira also has a biosimilar version of an oncolytic, trastuzumab, in clinical studies.
Hospira is currently conducting a Phase III U.S. clinical trial program for its U.S. epoetin product, which is being developed as a biosimilar to erythropoietin alpha in patients with renal (kidney) dysfunction who have anemia.
About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees. Learn more at www.hospira.com.
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