- Trial meets the primary endpoint of durable complete response
- Majority of patients who had a complete response had no evidence of any remaining detectable cancer cells
- Phase III clinical trial results served as basis for recent US FDA regulatory submission
CAMBRIDGE, 04-Jun-2018 — /EuropaWire/ — AstraZeneca and MedImmune, its global biologics research and development arm, today presented results from the Phase III (‘1053’) clinical trial that evaluated moxetumomab pasudotox in 80 patients with relapsed or refractory hairy cell leukaemia (HCL) who had received at least two prior lines of therapy.1
Moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin, showed a 75% objective response (OR) rate, a 41% complete response (CR) rate, and a 30% durable CR rate (primary endpoint). The majority of patients with a complete response had a durable response (73%; 24/33) and achieved a negative minimal residual disease (MRD) status (82%; 27/33). Findings from this pivotal trial were presented for the first time during an oral session at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA (Abstract #7004).
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Moxetumomab pasudotox is an investigational, first-in-class immunotoxin which we believe has the potential to advance outcomes for patients with relapsed or refractory hairy cell leukaemia, a condition with a high unmet need. It is also the first agent to be submitted for regulatory review from our Antibody Drug Conjugates platform, and as such demonstrates our commitment to developing novel treatments for blood cancer.”
Robert J. Kreitman, MD, Senior Investigator, Head of Clinical Immunotherapy Section, Laboratory of Molecular Biology, Center for Cancer Research, National Cancer Institute, said: “Hairy cell leukaemia is a rare, chronic blood cancer with no established standard of care for patients with relapsed or refractory disease following purine nucleoside analogue therapy. With very few treatments available, there remains significant unmet medical need for people with relapsed or refractory disease. The response rates observed in this trial, and elimination of the residual leukaemia cells that cause relapse in some patients, highlight the potential impact this potential new medicine could have on patients and the management of this disease.”
Summary of key results from the Phase III ‘1053’ single arm, multicentre clinical trial in 80 patients with relapsed or refractory HCL (16.7 months median follow-up), as determined by a blinded independent central review:
Endpoint | Moxetumomab pasudotox |
OR rate | 75% (60/80) |
CR rate | 41% (33/80) |
Durable CR rate | 30% (24/80) |
Haematologic remission* (blood count normalisation, HR) rate | 80% (64/80) |
MRD negative status (CR rate with immunohistochemistry MRD negativity) | 82% (27/33) |
*Haematologic remission (HR) is defined by: neutrophils > 1.5 x 109 /L, platelets > 100 x 109 /L, haemoglobin > 11 g/dL, no transfusions / growth factors > 4 weeks
The primary endpoint of the trial was durable CR, which is defined as CR with HR for >180 days. The median time to HR was 1 month. MRD refers to the small amounts of cancer cells that may remain after treatment.2 A high rate of negative MRD after therapy may further improve outcomes.3 The median duration of OR and median progression-free survival were not reached.
The most frequent treatment-related adverse events (AEs) were nausea (28%), peripheral oedema (26%), headache (21%), and pyrexia (20%); 8% had infections and 3% had neutropaenia deemed treatment-related. Three patient deaths occurred, none of which were determined to be treatment-related. Treatment-related AEs leading to discontinuation were haemolytic uraemic syndrome (HUS; 4 [5%]), capillary leak syndrome (CLS; 2 [3%]), and increased blood creatinine (2 [3%]). Seven patients (9%) had CLS and seven (9%) had HUS; this includes four (5%) patients who had both CLS and HUS. CLS and HUS were manageable and reversible.
In April 2018, AstraZeneca announced that the US Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for moxetumomab pasudotox for the treatment of adult patients with HCL who have received at least two prior lines of therapy. The BLA is based on results from the Phase III ‘1053’ clinical trial. The FDA has granted Priority Review status with a Prescription Drug User Fee Act action date set for the third quarter of 2018.
NOTES TO EDITORS
About Moxetumomab Pasudotox
Moxetumomab pasudotox (formerly CAT-8015 or HA22) is an investigational anti-CD22 recombinant immunotoxin and a potential new medicine with the opportunity to be a first-in-class treatment in the US for patients with relapsed or refractory hairy cell leukaemia (HCL) who have received at least two prior lines of therapy. Immunotoxins are a class of anticancer agents that combine the selectivity of antibodies to target drug delivery and the potency of toxins to kill target cancer cells.4Moxetumomab pasudotox is composed of a binding portion of an anti-CD22 antibody fused to a toxin. CD22 is a B-lymphocyte restricted transmembrane protein with a higher receptor density in HCL cells relative to normal B cells, making it an attractive therapeutic target for the treatment of this cancer.5 After binding to CD22, the molecule is internalised, processed and releases its modified protein toxin that inhibits protein synthesis, leading to apoptotic cell death. Moxetumomab pasudotox has been granted Orphan Drug Designation by the FDA and Orphan Designation by the European Medicines Agency for the treatment of HCL.
About Hairy Cell Leukaemia
HCL is a rare, incurable slow-growing leukaemia in which the bone marrow overproduces abnormal B cells or lymphocytes.6HCL can result in serious and life-threatening conditions, including infections, bleeding and anaemia.7 Approximately 1,000 people are diagnosed with HCL in the US each year.8,9,10 While many patients initially respond to treatment, up to 40% will relapse.11 With no established standard of care and very few treatments available, there remains significant unmet medical need for people with relapsed or refractory HCL.12,13
About the ‘1053’ Phase III Trial
The ‘1053’ trial is a single-arm, multicentre Phase III clinical trial assessing the efficacy, safety, immunogenicity and pharmacokinetics of moxetumomab pasudotox monotherapy in patients with relapsed or refractory HCL who have received at least two prior therapies. The trial is being conducted in 80 patients across 34 sites in 14 countries.14 The primary endpoint was durable complete response (CR), defined as CR with haematologic remission (blood count normalisation) for >180 days. Secondary outcome measures included overall response rate, relapse free survival, progression-free survival, time to response, safety, pharmacokinetic and immunogenic potential.14
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About AstraZeneca in Haematology
Leveraging its collective heritage in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus, and is accelerating development of a broad portfolio of potential blood cancer treatments. AstraZeneca and Acerta Pharma, its haematology research and development centre of excellence, received US FDA approval for the first medicine in this franchise, Calquence (acalabrutinib), in 2017.
About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular, Renal & Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and South San Francisco, CA. For more information, please visit www.medimmune.com.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
CONTACTS
Media Relations |
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Karen Birmingham | UK/Global | +44 203 749 5634 |
Rob Skelding | UK/Global | +44 203 749 5821 |
Matt Kent | UK/Global | +44 203 749 5906 |
Gonzalo Viña | UK/Global | +44 203 749 5916 |
Jacob Lund | Sweden | +46 8 553 260 20 |
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Craig Marks | Finance, Fixed Income, M&A | +44 7881 615 764 |
Henry Wheeler | Oncology | +44 203 749 5797 |
Mitchell Chan | Oncology; Other | +1 240 477 3771 |
Christer Gruvris | Brilinta; Diabetes | +44 203 749 5711 |
Nick Stone | Respiratory; Renal | +44 203 749 5716 |
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US Toll-Free | +1 866 381 7277 |
References
1 Kreitman, R, Dearden C, Zinzani P, Delgado J et al. Moxetumomab Pasudotox in Heavily Pretreated Patients with Relapsed/Refractory Hairy Cell Leukemia: Results of a Pivotal International Study. Oral presentation at: American Society of Clinical Oncology 2018; June 2018; Chicago, IL. Abstract #7004
2 Leukemia & Lymphoma Society. Glossary Results – Minimal Residual Disease. http://www.lls.org/llssearch?search-terms=minimal+residual+disease&search_language=en Accessed April 2018.
3 Thomas, Deborah A., Ravandi, F. et al. Importance of minimal residual disease in hairy cell leukemia: monoclonal antibodies as a therapeutic strategy. Leuk Lymphoma. 2009 Oct; 50(0 1): 27–31. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4109291/ Accessed April 2018.
4 G Aruna. Immunotoxins: A review of their use in cancer treatment. J Stem Cells Regn Med. 2006; 1(1): 31-36. Published online 2006 Dec 26. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3907961/ Accessed April 2018.
5 Park JH, Ross LL. Targeted Immunotherapy for Hairy cell leukemia. Journ Clin Onc 2012; 30: 1888–1890. http://ascopubs.org/doi/abs/10.1200/JCO.2011.39.8313. Accessed April 2018.
6 National Institutes of Health. Hairy Cell Leukemia. https://rarediseases.info.nih.gov/diseases/6560/hairy-cell-leukemiaAccessed April 2018.
7 Hairy Cell Leukemia Foundation. Complications. https://www.hairycellleukemia.org/about-hcl/complications/ Accessed April 2018.
8Troussard X, Cornet E. Hairy cell leukemia 2018: Update on diagnosis, risk‐stratification, and treatment. AM J Hematol. 2017; 92(12):1382-1390. Published online 2017 Nov 7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5698705/ Accessed April 2018.
9 Teras LR, DeSantis CE, Cerhan JR, Morton LM, Jemal A, Flowers CR. 2016 US Lymphoid Malignancy Statistics by World Health Organization Subtypes. CA Cancer J Clin. 2016; 66:443-459. https://onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21357 Accessed April 2018.
10 Grever MR, Blachly JS, Andritsos LA. Hairy cell leukemia: Update on molecular profiling and therapeutic advances. Blood. 2014; 28(5):197-203. https://www.sciencedirect.com/science/article/pii/S0268960X14000514 Accessed April 2018.
11 Hairy Cell Leukemia Foundation. Treatment. https://www.hairycellleukemia.org/about-hcl/treatment/ Accessed April 2018.
12 López-Rubio, M., Garcia-Marco, J. A. Current and emerging treatment options for hairy cell leukemia. OncoTargets and Therapy. 2015; 8: 2147–2156. http://doi.org/10.2147/OTT.S70316 Accessed April 2018.
13 National Institutes of Health. Hairy Cell Leukemia. https://rarediseases.info.nih.gov/diseases/6560/hairy-cell-leukemia Accessed December 2017
14 ClinicalTrials.gov. Moxetumomab pasudotox for Advanced Hairy Cell Leukemia. https://clinicaltrials.gov/ct2/show/study/NCT01829711?term=moxetumomab&rank=4&show_locs=Y#locn Accessed April 2018.
SOURCE: AstraZeneca
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- Digi Communications NV announces the extension of the agreement entered into between the Company’s subsidiary from Spain (Digi Spain) and Telefonica Moviles España, S.A. regarding the access to TME’s radio spectrum and mobile communication network and infrastructure
- Tiqets’ US Awakens Week Highlights Exclusive New Experiences From Newly Reopened Museums and Attractions
- Haizol Boosts Companies Operational Agility
- Eveliqure announces the initiation of a Phase 1 clinical study of its combined Shigella and ETEC vaccine candidate
- eFax führt das EMEA-Kanalprogramm ein
- eFax lance un programme de distribution dans la région EMEA
- Mono Solutions partners with Lokale Internetwerbung to launch in leadhub platform
- Syniti Launches Podcast Series to Address Growing Focus on Mergers, Acquisitions and Divestitures, featuring Leading CEOs
- Mono Solutions and Ecwid partner for the seamless delivery of websites with e-commerce for small businesses
- Galata Chemicals to produce Tin Stabilizers and Intermediates at Dahej, India
- Sintecs selected as Mentor’s value-added reseller of its HyperLynx® products in Europe focused on serving Altium Designer® users
- INFOCUS CORPORATION AND CELEXON EUROPE SIGN EXCLUSIVE EUROPEAN MASTER DISTRIBUTION AGREEMENT
- L’Awakening Week de Tiqets en France met en avant les nouvelles expériences exclusives de plus de 15 musées et attractions qui ont récemment rouvert
- Tiqets UK Awakens Celebrates Reopened Museums & Attractions and Sponsors Visits for NHS Staff
- Tiqets Awakening Weeks Brings Together 100+ Museums and Attractions to Celebrate Their Reopenings
- A Jewish-Bedouin Partnership is bringing the Negev cuisine to Europe
- Digi Communications NV announces the release of the H1 2020 Financial Results
- New Chief Financial Officers appointed at Mono Solutions & Bauer Media Group SME Services
- Digi Communications NV announces Investors Call on the Financial Results for H1 2020
- Palette Life Sciences AB and Gedeon Richter Plc. Receive National Marketing Authorization in the United Kingdom for Novel Pain Relief Product, LIDBREE™
- Palette Life Sciences launches Deflux.com/UK, an online resource for paediatric urologists, parents and caregivers in the United Kingdom
- Digi Communications N.V. announces the publishing of Independent Limited Assurance Report issued by the external auditor of the Company on 30 July 2020 regarding the information included in the current reports issued by the Company under Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- The Pavilions Hotels & Resorts Excited To Announce First Luxury Resort Brand In El Nido, Palawan Island Philippines
- New Customer Data Platform Options Emerge During Pandemic Slowdown: CDP Institute Report
- Digi Communications N.V. announces The Competition Council authorized the economic concentration accomplished by the Company’s Romanian subsidiary („RCS&RDS”) by gaining control over some of the assets held by Akta Telecom S.A., Digital Cable Systems S.A. and ATTP Telecommunications S.R.L.
- TABS Score™ Expands its European Footprint; Begins Partnership Discussions Amongst Key Players in EU Venture Ecosystem
- Mono and Brandify partner to bring appointment booking to local businesses
- Digi Communications N.V. announces ANCOM approval for RCS & RDS S.A. to continue to apply a surcharge for certain roaming services provided in the EEA for a renewed maximum period of 12 months
- DerbySoft Expands Metasearch Coverage for Hotels Around the World
- Palette Life Sciences Announces European Distribution Expansion for Deflux® and Solesta® for More Than Twenty Countries Through Five Leading Distributors and Direct Sales Effort
- Pierre Koukjian and Cedric Koukjian, Designer Duo in Collaboration with Bulgari
- Pierre Koukjian et Cédric Koukjian, Duo de designers en collaboration avec Bulgari
- Former Duff & Phelps EMEA Leader Yann Magnan joins 73 Strings as Co-founder and CEO
- Concern for the oceans drives consumers to 'vote with their forks' for sustainable seafood
- Digi Communications N.V.: Exercise of stock option by Marius Catalin Vărzaru, a Non-Executive Director and VP of the Board of Directors of the Company
- SecurLine Certified to Protect Classified Communications
- Digi Communications N.V. announces that a stock option programme was approved for employees and managers of the Romanian Subsidiary of the Company
- Digi Communications NV announces the exercise of stock options by the Executive Directors of the Company
- Matvil Corp. продолжает бороться с противозаконными действиями юридической системы Молдовы
- Digi Communications NV announces the release of the Q1 2020 Financial Results
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the general shareholders’ meeting approval from 30 April 2020
- MEDIS medical imaging systems acquires Advanced Medical Imaging Development S.r.l. (AMID) and secures further investment from Van Herk Ventures
- Digi Communications NV announces Investors Call on the Financial Results for Q1 2020
- Digi Communications N.V. announces the availability of the instructions on the 2019 share dividend payment
- Mono Solutions hires Chief Product Officer
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 30 Apr 2020
- Digi Communications N.V.: GSM resolutions from 30 Apr 2020 approving, amongst others, the 2019 Annual Accounts; availability of the adopted Annual Financial Report for the year ended Dec 31, 2019 for the Group
- RCH Embark on Lasting Partnership with Culinary Institute JRE
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Apr 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Apr 2020
- COVID-19: Digi Communications N.V. recommendation regarding participation of shareholders to the AGM convened for 30 April 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Apr 2020
- DIGI COMMUNICATIONS N.V.: Exercise of stock option by a Non-Executive Director of the Company
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Mar – 3 Apr 2020
- Chief Commercial Officer joins Mono Solutions
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 23 – 27 Mar 2020
- Digi Communications N.V. reports the admission to trading on the regulated market operated by the Irish Stock Exchange plc (trading as Euronext Dublin) of the senior secured notes issued by RCS & RDS S.A., its Romanian subsidiary
- Delft University of Technology Purchases its Second WebClip2Go Video Production System
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 16 – 20 Mar 2020
- Integrated Services Monitoring Capability Launched by Bridge Technologies
- Digi Communications N.V. announces Convocation of the Company’s general shareholders meeting for 30 April 2020 for the approval of, among others, the 2019 Annual Report and of the 2019 Financial Statements
- Digi Communications N.V. announces The Hungarian Competition Council’s decision to issue a new decision approving the Invitel transaction
- Digi Communications N.V. announces Business continuity in light of the novel coronavirus (“COVID-19”) outbreak
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 9 – 13 Mar 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in February 2020 or in other period but effective in February 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 2 – 6 Mar 2020
- « La levée du pilon sur la plate-forme » peut faire la différence entre le saint et l’ordinaire
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 24 – 28 Feb 2020
- EH GROUP ENGINEERING awarded EU Horizon 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 17 – 21 Feb 2020
- Digi Communications NV announces the release of the Preliminary Financial Results for year ended 31 December 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 10 – 14 Feb 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in January 2020 or in other period but effective in January 2020, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications NV announces Investor Call on the Preliminary Financial Results for the year ended 31 December 2019
- Consolidation Looms for Fast-Growing Customer Data Platform Industry: CDP Institute Report
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 3–7 Feb 2020
- Digi Communications N.V. hereby reports successful closing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 27 – 31 Jan 2020
- Digi Communications N.V.: Independent Limited Assurance Report issued by the external auditor on 30 Jan 2020 regarding the information included in the current reports under Law 24/2017 (Article 82) and FSA Regulation no. 5/2018
- Digi Communications N.V.: Rectification of the report published on 15 Jan 2020, regarding legal documents concluded by DIGI COMMUNICATIONS N.V. in other periods but effective in Dec 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Digi Communications N.V. reports the upsize and successful pricing of the offering of senior secured notes by RCS & RDS S.A., its Romanian subsidiary
- RCH To Present New Smart ECR, Robust and Vintage POS Systems at EuroShop 2020
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 20 – 24 Jan 2020
- Digi Communications N.V.: (i) launch of an offering by RCS & RDS S.A. of senior secured notes; (ii) issuance of a notice of conditional full redemption of all outstanding €550.0m 5.0% senior secured notes due 2023 issued by the Company and (iii) restatement by the Company of its unaudited interim condensed consolidated financial statements for the 9-month period ended 30 Sep 2019
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 13 – 17 Jan 2020
- Reporting of legal documents concluded by DIGI Communications N.V. in December 2019 or in other period but effective in December 2019, in accordance with article 82 of Law no. 24/2017 and FSA Regulation no. 5/2018
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 6 – 10 Jan 2020
- Berlin-based SuitePad named Best Places to Work in Hotel Tech 2020 category at HotelTechReport.com’s HotelTechAwards
- Notification shares buy-back: DIGI COMMUNICATIONS N.V. reports to the regulated market the transactions which occurred under the DIGI symbol, 30 Dec 2019 – 3 Jan 2020
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