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Pegaspargase (Oncaspar) for Acute Lymphoblastic Leukaemia

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Pegaspargase (Oncaspar) for Acute Lymphoblastic Leukaemia Horizon Scanning Centre January 2015 Pegaspargase (Oncaspar) for acute lymphoblastic leukaemia SUMMARY NIHR HSC ID: 3888 Pegaspargase (Oncaspar) in combination with chemotherapy is intended for the treatment of acute lymphoblastic leukaemia (ALL) in children, adolescents and adults. If licensed, pegaspargase will offer an additional treatment option for such patients and has the potential to improve safety, and reduce toxicity through the pegylation of Escherichia coli asparaginase (compared to non-pegylated asparaginase). Pegaspargase is an antineoplastic agent formed by linking Escherichia coli asparaginase with This briefing is polyethylene glycol (PEG). Linking the two may extend the duration the based on drug’s activity while reducing the potential for immunogenic reactions. information Pegaspargase (in combination with chemotherapy) is licensed in Germany available at the time and Poland for the treatment of ALL in children, adolescents and adults with of research and a known hypersensitivity to native L-asparaginases. limited literature search. It is not ALL is the only form of leukaemia that is more common in childhood (under intended to be a 15 years of age) and is characterised by a bimodal age pattern, with a peak definitive statement incidence at one to four years of age and a second increase in incidence in on the safety, those aged over 60 years. In the case of childhood ALL, there is an overall efficacy or survival rate of 80% at five years, but in adults the survival rate falls to 35% effectiveness of the at five years. In England there were 529 new diagnoses of ALL registered in health technology 2012. In the same year there were 202 deaths due to ALL registered in covered and should England. not be used for commercial Treatment of ALL consists of three phases: induction phase, consolidation purposes or phase and continuation treatment. Central nervous system (CNS) commissioning prophylaxis is also administered concurrently throughout treatment. Patients without additional typically receive chemotherapy for 2.0–2.5 years. In adults, stem cell information. transplantation and chemotherapy are considered equal treatment options. Allogeneic haemopoietic stem cell transplantation is an option for children with very high risk or persistent disease, and high risk adults in remission. Pegaspargase is currently in a number of phase III clinical trials comparing its effect on overall survival, complete response, and adverse effects against treatment with various other antineoplastic treatment regimens. These trials are expected to complete between 2019 and 2021. This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. NIHR Horizon Scanning Centre, University of Birmingham Email: [email protected] Web: http://www.hsc.nihr.ac.uk NIHR Horizon Scanning Centre TARGET GROUP • Acute lymphoblastic leukaemia (ALL): children, adolescents and adults - in combination with chemotherapy. TECHNOLOGY DESCRIPTION Pegaspargase (Oncaspar; asparaginase macrogol; PEG-asparaginase; PEG-L- asparaginase; PEGLA) is an antineoplastic agent formed by linking Escherichia coli asparaginase with polyethylene glycol (PEG). By conjugating the immunogenic E. coli asparaginase to PEG, the duration of activity of the drug may be extended while reducing the potential for immunogenic reactions. Asparaginase hydrolyses asparagine to L- aspartic acid and ammonia, leading to asparagine depletion, and cell death. In the phase III clinical trial, pegaspargase is administered by intravenous injection (IV) at 2,500units/m2 or 3,500units/m2 on day 1 of the continuation phase of treatment, days 1 and 15 of the reinduction I phase, and days 1 and 15 of the reinduction II phase; all in combination with chemotherapy which varied depending on risk stratification. Pegaspargase (in combination with chemotherapy) is licensed in Germany and Poland for the treatment of ALL in children, adolescents and adults with known hypersensitivity to native L- asparaginases. INNOVATION and/or ADVANTAGES If licensed, pegaspargase will offer an additional treatment option for children, adolescents and adults with ALL. Pegaspargase has the potential to improve safety through the pegylation of Escherichia coli asparaginase. DEVELOPER Pfizer; Sigma-Tau Pharmaceuticals Ltd (EU licensee). AVAILABILITY, LAUNCH OR MARKETING The company submitted a Marketing Authorisation Application to the EU in July 2014. PATIENT GROUP BACKGROUND ALL is a malignancy of lymphocytes and lymphocyte-producing cells. In persons with ALL, there is excess production of immature lymphocyte-precursor cells, called blast cells, in the bone marrow. Eventually this overgrowth affects normal haemopoiesis, and there is a reduction in the numbers of red cells, white cells and platelets in the blood1. The most common symptoms of ALL are2: • Anaemia, which results in fatigue and breathlessness. • Low platelet counts, which may result in bruising and bleeding from mucous membranes and the gut. 2 NIHR Horizon Scanning Centre • Low white cell counts, high numbers of abnormal cells and high metabolic rate, resulting in persistent infections and fever that is often present even in the absence of clear indications of infection. NHS or GOVERNMENT PRIORITY AREA This topic is relevant to: • Improving Outcomes: A Strategy for Cancer (2011). • NHS England. 2013/14 NHS Standard Contract for Cancer: Chemotherapy (Adult). B15/S/a. • NHS England. 2013/14 NHS Standard Contract for Cancer: Chemotherapy (Children, Teenagers and Young Adults). B12/S/b. • NHS England. 2013/14 NHS Standard Contract for Cancer: Radiotherapy (All Ages). B01/S/a. • NHS England. Clinical Commissioning Policy: Haematopoietic Stem Cell Transplantation. NHSCB/B04/P/a. April 2013. CLINICAL NEED and BURDEN OF DISEASE ALL is the only form of leukaemia that is more common in childhood (under 15 years of age)1, accounting for 75% of leukaemia diagnoses in paediatric patients3. ALL is characterised by a bimodal age pattern, with a peak incidence at one to four years of age and a second increase in incidence at ages over 60 years4. In the case of childhood ALL, there is an overall survival rate of 80% at five years, but in adult patients the survival rate is reduced to approximately 35% at five years5. In England there were 529 new diagnoses of ALL registered in 20126. In the same year there were 202 deaths due to ALL registered in England7. In 2012, there were 25,330 hospital admissions for ALL (ICD10 C91.0) in England, resulting in 40,642 bed-days and 26,027 finished consultant episodes8. The population likely to be eligible to receive pegaspargase could not be estimated from available published sources. PATIENT PATHWAY RELEVANT GUIDANCE NICE Guidance • NICE Clinical Guideline. Referral for suspected cancer (CG27). June 2005. • NICE Cancer Service Guidance. Improving outcomes in haemato-oncology cancer; the manual. October 2003. Other Guidance • National Comprehensive Cancer Network. Acute Lymphoblastic Leukaemia 20139. • The European Group for Blood and Marrow Transplantation. Handbook on Haemopoietic Stem Cell Transplantation. Revised edition 201210. • The American Society for Blood and Marrow Transplantation Executive Committee. The role of cytotoxic therapy with haematopoietic stem cell transplantation in the treatment of adult acute lymphoblastic leukaemia: update of the 2006 evidence based-review. 201211. 3 NIHR Horizon Scanning Centre CURRENT TREATMENT OPTIONS Treatment for ALL aims to induce clinical remission (induction phase), target cells that are clinically undetectable (consolidation phase) and maintain the patient in remission (continuation treatment). Additional CNS prophylaxis, which consists of concurrent chemotherapy, is also given throughout the entire period of treatment3. Patients typically receive chemotherapy for 2.0–2.5 years12. In adults, stem cell transplantation and chemotherapy are considered equal treatment options. Allogeneic haemopoietic stem cell transplantation is an option for children with very high risk or persistent disease, and high risk adults in remission13,14,15,16. EFFICACY and SAFETY The tables below contain details of a number of phase II and III clinical trials of pegaspargase for the treatment of ALL. In addition to the trials listed, there are a large number of other investigator-led studies on regimens containing pegaspargase for the treatment of ALL. Trial NCT00549848; children NCT01117441; UKALL14, EudraCT 2009- aged up to 18 years; pegaspargase with 012717-22; pegaspargase higher dose PEG- chemotherapy; phase III. with chemotherapy; phase asparaginase vs III. conventional dose PEG- asparaginase, both in combination with chemotherapy; phase III. Sponsor and St. Jude Children's University of Schleswig- University College London. collaborators Research Hospital; Holstein; Deutsche National Cancer Institute Krebshilfe e.V., Bonn (NCI); Enzon (Germany); Sigma-Tau Pharmaceuticals, Inc. Pharma Limited; medac GmbH. Status Ongoing. Ongoing. Ongoing. Source of Trial registry17, Trial registry18, Trial registry19, information manufacturer. manufacturer. publication20, manufacturer. Location USA. EU (not UK), Australia, UK. and Israel Design Randomised, active- Randomised, active- Randomised, active- controlled. controllled. controlled. Participants n=420 (planned); aged n=4,750 (planned); aged n=720 (planned); aged ≤18 years; precursor B-cell ≥1 year
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