OCTAPHARMA

Real-world data and expert perspectives on state-of-the-art clinical practice for the management of infection in patients with CLL will be showcased during the Octapharma Update-in-Hematology session at the EHA Hybrid Congress on June 9, 2023, in Frankfurt, Germany.

Secondary immunodeficiency (SID) is a common complication in patients with haematological malignancies such as CLL. Up to 85% of patients with CLL develop hypogammaglobulinemia, either due to the underlying disease or as a side effect of treatment.¹ Patients with hypogammaglobulinemia are more likely to develop infections, which are a major cause of morbidity and account for up to 60% of deaths in patients with CLL.² The use of immunoglobulin therapy (intravenous and subcutaneous) is well established as secondary prophylaxis once patients experience a severe/repeated infection. Furthermore, primary prophylaxis with immunoglobulin therapy has been suggested to decrease infection rates but more robust data are needed to evaluate the safety and efficacy of this strategy.^3-5

Octapharma’s interactive Update-in-Hematology session “Chronic Lymphocytic Leukemia (CLL) and Beyond: Management of the Infection Burden” will begin with a spotlight on the risk of infections in patients with CLL using a data-driven and machine learning approach by Dr Caspar da Cunha-Bang, Rigshospitalet, Copenhagen, Denmark. This will be followed by a discussion on the risk factors for infections and the importance of guideline recommendations in choosing the right treatment to reduce the severity of these infections by Professor Hartmut Link, Haematology Oncology Kaiserslautern, Kaiserslautern, Germany. Finally, Professor Livio Trentin, University of Padua, Italy, will speak about his experience using subcutaneous immunoglobulin therapy for infection prophylaxis in patients with CLL. In addition, he will share his first-hand experience with ongoing research into this area, including the PRO-SID clinical trial and its potential for primary infection prophylaxis. The session will round off with an exciting panel discussion bringing together the audience and experts to exchange views on challenging cases of infections associated with CLL.

Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Centre in Ulm, Germany, will chair the session. He stated, “The COVID-19 pandemic has vividly reminded us about the impact of infections on patients. Therefore, novel perspectives in approaching prophylaxis in CLL are highly valued – I am very much looking forward to discussing some of these exciting advances in the field with the international panel of speakers and audience at this session.”

Octapharma has a longstanding commitment to improving the management of patients with SID, and in 2020 launched PRO-SID (NCT04502030), a Phase III clinical trial investigating primary infection prophylaxis with panzyga^®, a human immunoglobulin for intravenous administration, in patients with CLL and SID. Over 240 adult patients with CLL and hypogammaglobulinemia (IgG levels < 5 g/L) who are receiving antineoplastic treatment will be enrolled to investigate the efficacy and safety of panzyga^® compared with placebo. The primary outcome is the occurrence of at least one major infection over 52 weeks. With this trial, Octapharma aims to gather robust clinical data on the efficacy of primary prophylaxis in managing infection risk in patients with SID and expand the treatment options in these patients.

Livio Trentin, Professor of Haematology and Director of the Haematology Unit at Padua University, is supervising one site of the PRO-SID trial. He commented: “There remains a significant need to establish the most effective approach to managing patients with haematological malignancies and secondary immunodeficiency. Proactive management of infections in these patients using primary prophylaxis with intravenous immunoglobulin has great potential but it is important that we gather robust evidence on the efficacy and safety of this treatment option through trials such as PRO-SID.”

Olaf Walter, Board Member at Octapharma, added: “Octapharma is delighted to support this Update-in-Hematology session, and we look forward to facilitating expert perspectives and audience interaction to improve the care of patients with CLL. We are also proud to support the PRO-SID study which will provide important data to understand how to improve and potentially save the lives of these patients.”

In addition to this Update-in-Hematology session, the strong commitment of Octapharma to the field of SID will be illustrated by the presentation of a subgroup analysis of patients with SID in a non-interventional safety study conducted in Germany. The results of this analysis on 3,846 SID patients will be displayed and commented during the poster session of the Congress on June 9, 2023:

• P1505: “Tolerability and safety of intravenous immunoglobulins (5% and 10%) for the treatment of patients with secondary immunodeficiencies – Final subgroup results of a non-interventional safety study,” presented by Octapharma.

We look forward to seeing you soon at EHA 2023 – drop by the Octapharma booth on-site in Frankfurt for more information.

About panzyga^®

Panzyga^® is a 10% human normal immunoglobulin solution ready for intravenous administration. Panzyga^® is approved for use in treatment of primary immunodeficiency, idiopathic thrombocytopenic purpura (ITP) and chronic inflammatory demyelinating polyneuropathy (CIDP) in the USA, Europe and Canada. It is also approved for secondary immunodeficiencies and Guillain Barré syndrome in Europe and Canada and for Kawasaki disease, and multifocal motor neuropathy (MMN) in Europe.

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, and operates more than 190 plasma donation centres across Europe and the USA.

References

1. Sanchez-Ramon S et al. Challenges in the Role of Gammaglobulin Replacement Therapy and Vaccination Strategies for Hematological Malignancy. Front Immunol 2016; 7:317.
2. Tadmor T et al. A Review of the Infection Pathogenesis and Prophylaxis Recommendations in Patients with Chronic Lymphocytic Leukemia. Exp Rev Hematol 2018; 11:57-70.
3. Cornely O at al. The Prosid Study: Evaluating Efficacy and Safety of Intravenous Immunoglobulin (IVIG) 10% in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia – Study Design. Blood 2020; 136 (Suppl 1):20-1.
4. Agostini C et al. Prophylactic Immunoglobulin Therapy in Secondary Immune Deficiency – An Expert Opinion. Expert Rev Clin Immunol 2016; 12:921-6.
5. Visentin A et al. A Retrospective Study on the Efficacy of Subcutaneous Immunoglobulin as Compared to Intravenous Formulation in Patients with Chronic Lymphocytic Leukemia and Secondary Antibody Deficiency. Curr Oncol. 2022 Dec 25; 30(1):274-283.

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