EUSA Pharma Announces New QARZIBA®▼ (Dinutuximab beta) Data to Be Presented at 2019 ASCO Annual Meeting

BOSTON and HEMEL HEMPSTED, England, May 29, 2019 /PRNewswire/ -- EUSA Pharma (EUSA), a global biopharmaceutical company focused on oncology and rare disease, today announces that the Principal Investigators from two studies of QARZIBA®▼ (dinutuximab beta)^1,2 in the treatment of high-risk neuroblastoma will present new data at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 31 through June 4, 2019 in Chicago, IL.

Professor Ruth Ladenstein, St Anna Children's Hospital and Department of Pediatrics, Medical University Vienna, Austria, and Principal Investigator of the HR-NBL1/SIOPEN trial, said, "The data to be presented at ASCO, which are based on extensive collaboration between the SIOPEN network, Apeiron Biologics and EUSA Pharma, support the use of dinutuximab beta as standard-of-care immunotherapy for high-risk neuroblastoma patients without the addition of subcutaneous interleukin-2."

Professor Holger Lode, Chair of Pediatrics and Pediatric Hematology and Oncology, University Medicine Griefswald, Germany, and Principal Investigator of the SIOPEN LTI trial, added, "These new results from the SIOPEN study further support the role of dinutuximab beta in treating children with high-risk relapsed/refractory neuroblastoma, a deadly disease and ultra-orphan indication."

Lee Morley, EUSA Pharma's Chief Executive Officer, said, "We are delighted these new data supporting the efficacy and tolerability of QARZIBA®▼ (dinutuximab beta) in both the maintenance phase of first-line treatment of high-risk neuroblastoma as well as relapsed/refractory neuroblastoma will be presented at the prestigious ASCO Annual Meeting. With the recent appointment of Darrel Cohen MD PhD as EUSA's Head of Clinical Development, we are exploring further development of dinutuximab beta in neuroblastoma, and other GD2-expressing oncology indications with high unmet clinical need, as part of our commitment to ensuring patient access to this important medicine globally."

ASCO 2019 Presentations
The presentations by Professor Ladenstein and Professor Lode will be held in the Paediatric Oncology Oral Abstract Session on Sunday, June 2, 8:00-11:00am.

• Randomization of dose-reduced subcutaneous interleukin-2 (scIL2) in maintenance immunotherapy (IT) with anti-GD2 antibody dinutuximab beta (DB) long-term infusion (LTI) in front–line high-risk neuroblastoma patients: Early results from the HR-NBL1/SIOPEN trial. Abstract 10013.
• Randomized use of anti-GD2 antibody dinutuximab beta (DB) long-term infusion with and without subcutaneous interleukin-2 (scIL-2) in high-risk neuroblastoma patients with relapsed and refractory disease: Results from the SIOPEN LTI-trial. Abstract 10014.

About QARZIBA®▼ (dinutuximab beta)
Dinutuximab beta is a chimeric monoclonal IgG1 antibody that is specifically directed against the carbohydrate moiety of disialoganglioside 2 (GD2), which is overexpressed on neuroblastoma cells.

The efficacy of dinutuximab beta has been evaluated in a randomised controlled trial comparing the administration of dinutuximab beta with or without IL-2 in the first-line treatment of patients with high-risk neuroblastoma and in two single-arm studies in the relapsed/refractory setting.

Dinutuximab beta was approved by the European Commission on 8 May 2017 and is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.

In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, dinutuximab beta should be combined with interleukin-2 (IL-2). For full prescribing information please see the Summary of Product Characteristics^3.

About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit www.eusapharma.com.

¹J Clin Oncol 37, 2019 (suppl; abstr 10013)

²J Clin Oncol 37, 2019 (suppl; abstr 10014)

³ https://www.ema.europa.eu/en/documents/product-information/qarziba-epar-product-information_en.pdf (Accessed 23.05.19)

SOURCE EUSA Pharma