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Hospital Healthcare Europe

Press Releases

Take a look at a selection of our recent media coverage:

World’s first clinical guidelines for chronic fungal lung infections

23rd December 2015

The world’s first guidelines for chronic fungal lung infections for doctors and laboratories have been published by the European Respiratory Society (ERS) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID).

Published in the European Respiratory Journal, these new guidelines describe the important features of this disease and provide comprehensive treatment recommendations.

Chronic pulmonary aspergillosis (CPA) is a subtle and insidious problem in patients with already damaged lungs. It kills about 80% of sufferers over five years, unless diagnosed and treated with long-term antifungals. Across Europe, an estimated 240,000 people have CPA, and worldwide around 3 million. The late stages of CPA (aspergilloma) are familiar to respiratory specialists, but the early features are often missed.

Major improvements in understanding this debilitating and ultimately fatal disorder have resulted from research undertaken in Europe, India and Japan over the last 10 years. However, no therapies are approved by the European Medicines Agency (EMA) for treatment, and very few diagnostic tests and therapies have been compared. In many parts of the world, the basic tests required are not yet available.

Professor David Denning of the University of Manchester who lead the CPA guidelines group, said: “The UK National Health Service recognised the challenges posed by these patients by setting up the National Aspergillosis Centre and its associated laboratory the Mycology Reference Centre in 2009. The experience gained from seeing hundreds of patients has contributed to the quality of care, although much more research and new oral antifungal drugs are both required to reduce the marked disability caused by CPA.

Patient Michael Miller, age 65 from Leeds, described his experience: “I had aspergillosis in 2006, which improved with a long course of antifungal capsules. In 2012, I started to get worse and worse, and it took three years to recognise recurrence of my aspergillosis. By this time, I was so breathless and my X-ray was much worse.

ESCMID President Professor Murat Akova stated: “I am delighted that this ground breaking clinical guideline has been published; the management of chronic fungal infection, notably CPA, is difficult, requiring a high level of laboratory and clinical expertise.

ERS Guidelines Director, Dr Marc Miravitlles, commented: “We welcome the publication of this guideline, which provides key insights into the main features of the disease and treatment recommendations. By establishing this expert consensus on the topic, we aim to improve the early diagnosis of CPA and increase recognition of the condition to ultimately improve outcomes for patients.

The guidelines are a product of a two-year collaboration between ESCMID and ERS. In parallel to these CPA recommendations, ESCMID is currently developing wider guidelines for invasive aspergillosis in general, which will be published in due course. The latter are developed by Professor Andrew Ullmann of the Julius Maximilian University of Würzburg, chairman of ESCMID’s fungal infection study group EFISG.

EFISG chairman Andrew Ullmann commented: “This is first guideline on chronic pulmonary aspergillosis worldwide. It is the result of another joint effort of ESCMID and ERS experts who, in a truly interdisciplinary collaboration, prepared and published guidance for colleagues on a group of complex diseases that are difficult to manage. Aspergillosis is more than chronic lung infection and a larger document addressing all aspects of Aspergillosis infections is under preparation by EFISG.

Keytruda® significantly improves survival compared with chemotherapy in NSCLC

21st December 2015

MSD announced results from the pivotal KEYNOTE-010 study, the first study of its kind to evaluate the potential of an immunotherapy compared to chemotherapy based on prospective measurement of PD-L1 (programmed death receptor-ligand 1) expression in patients with previously treated advanced non-small cell lung cancer (NSCLC).

In the Phase II/III study, Keytruda® (pembrolizumab), MSD’s anti-PD-1 (programmed death receptor-1) therapy, significantly improved overall survival (OS) compared to chemotherapy in patients with any level of PD-L1 expression, as defined by a tumour proportion score (TPS) of 1% or more. The results were published in The Lancet and will be presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress.

Because lung cancer remains one of the most common and most challenging cancers to treat, understanding the role that pembrolizumab can play in helping patients was essential to our development program. In this study in patients with PD-L1 expression of 1% or greater, pembrolizumab demonstrably improved overall survival compared to chemotherapy in previously-treated patients with non-small cell lung cancer, including both squamous and non-squamous histologies,” said Dr Roger M Perlmutter, president,Merck & Co., Inc.’s/MSDResearch Laboratories.

Overall Survival Findings from KEYNOTE-010
The Phase II/III KEYNOTE-010 study included 1034 patients with advanced NSCLC with PD-L1 expression (TPS of 1% or more). Similar findings were shown in patients who received of pembrolizumab at doses of 2mg/kg every three weeks (n=345) and 10mg/kg every three weeks (n=346). Both groups of patients who received pembrolizumab were compared to patients who received docetaxel (n=343). PD-L1 expression was assessed by the immunohistochemistry companion diagnostic test PD-L1 IHC 22C3 PharmDx, made by Dako North America, Inc., an Agilent Technologies Company. The findings from KEYNOTE-010 are based on the final study analysis. The median follow-up was 13.1 months (IQR, 8.6–17.7).1

In the total study population (all levels of PD-L1 expression), both doses of pembrolizumab studied significantly improved overall survival (OS) compared with docetaxel. Specifically, pembrolizumab resulted in a 29% improvement in OS for the 2mg/kg dose (HR 0.71, P=0.0008; 95% CI, 0.58–0.88) and a 39% improvement in OS for the 10mg/kg dose (HR 0.61, P<0.0001; 95% CI, 0.49–0.75), compared to docetaxel. The estimated 1-year OS rates for pembrolizumab were 43.2% and 52.3%, respectively, compared to 34.6% for docetaxel. Median OS for pembrolizumab were 10.4 months (95% CI, 9.4–11.9) and 12.7 months (95% CI, 10.0–17.3), respectively, compared to 8.5 months for docetaxel (95% CI, 7.5–9.8).1

Among patients with higher levels of PD-L1 expression (a TPS score of 50% or greater), OS was superior for both pembrolizumab doses compared with docetaxel. Specifically, pembrolizumab improved OS by 46 percent for the 2mg/kg dose (HR 0.54, P=0.0002; 95% CI, 0.38–0.77) and by 50% for the 10mg/kg dose (HR 0.50, P<0.0001; 95% CI, 0.36–0.70), compared to docetaxel. Median OS for pembrolizumab (2mg/kg and 10mg/kg, respectively) was 14.9 months (95% CI, 10.4 to not reached) and 17.3 months (95% CI, 11.8 to not reached), compared to 8.2 months for docetaxel (95% CI, 6.4–10.7).1

Additional Findings from KEYNOTE-010
In the total study population, pembrolizumab prolonged progression-free survival (PFS) at both doses, though statistical significance was not met (HR 0.88 [95% CI, 0.74–1.05], P=0.07 for 2mg/kg; HR 0.79 [95% CI, 0.66–0.94], P=0.004 for 10mg/kg). Among patients treated with pembrolizumab (2mg/kg and 10mg/kg, respectively), median PFS was 3.9 months (95% CI, 3.1–4.1) and 4.0 months (95% CI, 2.7–4.3), compared to 4.0 months for docetaxel (95% CI, 3.1–4.2).1

Patients with higher levels of PD-L1 expression (a TPS score of 50% or greater) who were treated with pembrolizumab had significantly prolonged PFS compared to docetaxel (HR 0.59 [95% CI, 0.44–0.78, P=0.0001] for 2mg/kg; HR 0.59 [95% CI, 0.45–0.78, P<0.0001] for 10mg/kg). Among patients treated with pembrolizumab (2mg/kg and 10mg/kg, respectively), median PFS was 5.0 months (95% CI, 4.0–6.5) and 5.2 months (95% CI, 4.1–8.1), compared to 4.1 months for docetaxel (95% CI, 3.6–4.3).1

Additionally, the safety of pembrolizumab was consistent with what has been seen in previous trials among advanced lung cancer patients. Grade 3–5 treatment-related adverse events for pembrolizumab (2mg/kg and 10mg/kg, respectively) included: decreased appetite (n=3, n=1), fatigue (n=4, n=6), nausea (n=1, n=2), rash (n=1, n=1), diarrhoea (n=2, n=0), asthenia (n=1, n=2), stomatitis (n=0, n=1), and anaemia (n=3, n=1). The most common immune-mediated adverse events for pembrolizumab (2mg/kg and 10mg/kg, respectively) included: hypothyroidism (8% [n=28], 8% [n=28]), hyperthyroidism (4% [n=12], 6% [n=20]), and pneumonitis (5% [n=16], 4% [n=15]). There were three treatment-related deaths among patients receiving pembrolizumab at the 2mg/kg dose (pneumonitis [n=2], pneumonia [n=1]) and three treatment-related deaths among patients receiving pembrolizumab at the 10mg/kg dose (myocardial infarction [n=1], pneumonia [n=1], and pneumonitis [n=1]).1


  1. Herbst RS et al: Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. The Lancet. Published online December 19, 2015

Launches give Roche the most comprehensive immunosuppressive drug monitoring portfolio

Roche announced the market availability of the new Elecsys® Sirolimus and Everolimus immunosuppressive drug assays.

The launch of these two assays, which complement the currently available mycophenolic acid (MPA), Elecsys Tacrolimus and Cyclosporine assays, completes the Roche Diagnostics immunosuppressive drug monitoring portfolio.

The Elecsys Immunosuppressive drug (ISD) assays offer high precision and consistent results, which are vital factors in helping physicians to correctly tailor immunosuppressive therapy to individual organ transplant patients.

Immunosuppressive drug monitoring requires a high level of precision to ensure that patients receive the optimal therapy. The new Elecsys ISD Assays will offer reliable, life-long testing to patients who have had organ transplants,” said Jean-Claude Gottraux, Head of Roche Professional Diagnostics. “This full offering also provides clinical laboratories with the opportunity to optimise their workflows and consolidate testing for a wide range of relevant markers on a single platform.

This is a further example of the Roche commitment to invest in personalised healthcare”. Immunosuppressants must be taken continuously by recipients of organ transplants to prevent transplant rejection. If the dose of the medication is too low it may lead to organ rejection, while excessive doses can cause severe side effects. Therefore, it is important to monitor their concentrations in patients’ blood precisely.

With the Elecsys ISD assays, the required pretreatment step can be done with only a single procedure and reagent, which brings a clear benefit in terms of testing efficiency and reduction of handling errors.

bene-Arzneimittel receives orphan drug status for pentosan polysulphate

18th December 2015

In European and US medical guidelines, pentosan polysulphate is established as a standard drug for the treatment of the severe chronic bladder disease interstitial cystitis (IC).

The drug has been awarded the status of an orphan drug from the European Medicines Agency, EMA, for the indication of IC.

Interstitial cystitis (IC) is a rare or so-called orphan disease. The drug substance PPS has been officially registered as an orphan drug for this indication by the European Medicines Agency, EMA. “Receiving orphan drug status for pentosan polysulphate in the European Union is a great success for bene,” says CEO Dr Guenter Auerbach. “To be able to offer patients with rare but serious conditions innovative medications in the area of urology is an important milestone for the future of our company.

About IC
IC is a severe chronic bladder disease that substantially reduces quality of life. Affecting less than two patients per 10,000 people on average and being associated with a large degree of suffering, the condition has been officially recognised as an orphan disease. For those affected by the condition, it means very frequent and painful urination, as well as severe pain in the lower abdomen.

The causes of this chronic disease include damage to the bladder lining, affecting the glycosaminoglycan (GAG) layer in particular. As a result, the protective effect of this layer is reduced, and toxic constituents of urine are able to penetrate into underlying tissue layers and cause tissue irritation or inflammation.

UK company launches full range of pioneering pressure mattress solutions

17th December 2015

Pressure ulcer specialist Rober, is delighted to announce the launch of a full range of alternating pressure mattress solutions, catering for a variety of patients’ needs from everyday nursing environments to acute care facilities.

The pioneering range of mattresses and overlays includes solutions for immobile, critically ill and bariatric patients that have been developed in conjunction with clinicians. Featuring clinically proven technology that prevents pressure injuries from developing, Rober’s solutions also promote the healing of established ulcers.

The new generation of mattresses are fully automatic and patients nursed upon them require less manual repositioning. Designed to mechanically replicate the body’s natural spontaneous movement in response to unrelieved pressure, these mattresses provide regular and complete pressure elimination to all parts of the body in contact with the mattress.  

The company has focused on four key areas – microclimate control, patient safety and comfort, maximising infection control and offering additional nursing support. Additional features such as a touch screen visual display panel, comfort settings, timed static mode, audible and visual alarms, permanently inflated side formers, maximum inflation mode, and simplicity of decontamination for effective infection control provide benefits to both patients and busy nursing staff.

Rober, leaders in the development and manufacture of pressure ulcer prevention and therapy, have developed two mattress ranges – NoDec®, a premium range and a cost effective AirFlex® range, which has been designed to fulfil the requirements of ‘affordable healthcare’.

Mike Hutson, Chief Executive of Rober, said: “Over the last few years we have invested heavily in R&D to create a full range of pressure ulcer solutions that cater for all types of patients in different healthcare settings.  All of our technologies have been designed to offer maximum flexibility to patients who are at risk of pressure damage. They are effective and proven solutions in the prevention and treatment of pressure ulcers to help ‘stop the pressure”.

Pressure ulcers are a rising problem around the world and in the UK alone, they affect over 700,000 people a year and add an additional £4000 per ulcer onto each patient’s care bill. They are also linked to prolonged hospitalisation, pain, social isolation and in worst cases, death.

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UHS NHS Foundation Trust selects OnBase by Hyland for its paperless patient care strategy

16th December 2015

University Hospital Southampton NHS Foundation Trust (UHS) has announced it is to implement the enterprise content management (ECM) system OnBase by Hyland, which has been enabled by NHS England’s decision to back the project through its Integrated Digital Care Technology Fund.

The ground breaking electronic health records system, due to be operational by the end of 2016, will provide information sharing for clinicians across UHS, Solent NHS Trust and Southern Healthcare NHS Foundation Trust, and significantly enhance continuity of care while reducing costs. A programme of scanning any remaining patient care paper documents is scheduled to be completed before the closure of the trust’s health records library in 2017.

OnBase, which was selected following an extensive review by doctors, nurses and midwives at UHS, will enable the trust to deliver paperless patient care by replacing paper forms with electronic forms, capturing externally generated paper as it enters the trust and digitise its existing paper records.

This is the final element of the trust’s electronic patient record strategy, which is set to provide immediate access to health records. The system will allow information to be shared between clinicians, using secure computers and tablets.

UHS provides services to some 1.9 million people living in Southampton and south Hampshire, as well as specialist services, such as neurosciences, cardiac services and children’s intensive care, to more than 3.7 million people across central southern England and the Channel Islands. The trust is also a major centre for teaching and research, in association with the University of Southampton and partners, which include the Medical Research Council and Wellcome Trust.

Derek Waller, deputy medical director, chief clinical information officer of UHS, said: “This project is great news for patients and clinicians alike, as it will make healthcare safer and more efficient. Over the next three years, the system will revolutionise healthcare delivery and reduce the need for long-term storage of paper health records, saving UHS and our partners Southern Health NHS Foundation Trust and Solent NHS Trust more than £1 million a year.

OnBase is currently used by more than 1800 healthcare organisations, to manage unstructured clinical and business data. Its dedicated nurses, therapists, health information management and software specialists, supported by a series of healthcare advisory boards, have a long track record in working with providers of clinical applications, which has recently seen OnBase collaborating on the implementation of integrated systems for Wrightington, Wigan and Leigh NHS Foundation Trust (WWL) and the Liverpool Heart and Chest Hospital (LHCH).

Adrian Byrne, director of information management & technology of UHS, explained: “This will enable our teaching hospitals to remain exemplar sites for world-class healthcare, research and innovation. The move from paper medical records to electronic records also supports the government’s vision of a paperless NHS by 2020 and provides a firm footing for the future of healthcare in Southampton.

Steve Rudland, customer advocacy & consulting lead – EMEA, of Hyland, creator of OnBase, concluded: “UHS has a clear vision for success. Taking control of their information enables the trust to improve processes, care and outcomes. We look forward to helping them to make this vision a reality.

Proton Partners International bring top cancer technology to Wales

14th December 2015

The equipment fitted at the UK’s first proton beam therapy centre will provide cancer patients with the most advanced cancer technology available, Proton Partners International Ltd CEO Mike Moran said.

Committed to working with renowned international companies, Proton Partners International will be bringing the world’s first and only digital PET CT system to Wales.

Philips’ Vereos PET CT is the first commercially available scanner to offer truly digital PET, significantly improving the visual quality and quantitative accuracy of PET imaging. At the heart of Vereos is a state-of-the-art detector that converts detected photons directly into digital information.

Vereos is designed to improve current clinical practice, as well as broaden the range of imaging techniques that are currently limited by the performance of conventional analogue PET CT systems.

Proton Partners has started working towards opening the UK’s first proton beam therapy centre in Newport, Gwent, which is expected to be operational by 2017.

Mike Moran said: “This digital PET CT scanner will be the first of its kind in the UK and reflects the strength of our commitment to improve the treatment of cancer.

Currently there is only one PET CT scanner in Wales, but it’s not digital. The accuracy of this new PET CT system means that we will be able to produce much clearer imagery to support early diagnosis and determine which patients are responding better to treatment with follow up scans. This means that our patients will receive a better, and more sophisticated, level of care.

Our centres will not only provide imaging, radiotherapy, chemotherapy and proton therapy, but they will also be a hub to drive improvements in cancer treatment in the UK.”

Neil Mesher, Managing Director, Health Systems, Philips UKI, added: “We are delighted to be working with Proton Partners to bring the first Vereos system to the UK. This breakthrough innovation combines exceptional quality and accuracy in imaging at low dose rates helping clinicians get answers first time around enabling them to make more confident diagnoses for patients.

Philips has also been appointed to deliver software and technology tools in the three centres to be opened by Proton Partners, including Philips’ Pinnacle Treatment Planning, which delivers an intuitive planning environment that simplifies workflow. Other leading global partners include Ion Beam Applications (IBA) and Elekta.

Best-of-breed EPRs prove their effectiveness in achieving digital maturity

10th December 2015

Three of the top ten Trusts on the latest CDMI ranking (Liverpool Heart and Chest – joint-first, the Walton Centre and Dorset) have built their clinical systems strategy on an interoperable approach with Silverlink’s PCS PAS as the foundation of their Electronic Patient Record (EPR).

The CDMI was developed specifically for the NHS in order to measure the availability and capabilities of clinical systems in the Trusts throughout England. The CMDI is based on a wide number of measures that are readily accessible and allow for better, more informed decision-making about strategies and investment by providing a clear view into the success of individual Trust’s eHealth approach.

According to CDMI, digitally mature environments support improvements in patient outcomes and experience, increased efficiencies in service administration, and create a paperless workspace – a goal that NHS England hopes to achieve by 2018. As demonstrated by three Trusts on the CDMI rankings list, an interoperable approach using best-of-breed solutions underpinned by PCS PAS can successfully deliver breadth and depth of clinical maturity.

When decision-makers consider strategic approaches, integrated EPRs are often assumed as the quickest way to gain digital maturity but, as demonstrated by the latest CDMI rankings, this is not always the case. An integrated EPR solution can be very costly and is not necessarily the most pragmatic approach to addressing the complex clinical, technological and organisational needs of a Trust.

Implementing a best-of-breed solution allows for a greater choice of systems and can be implemented at the timings and pace most suitable to your organisation.  Furthermore, access to best-of-breed departmental solutions delivers a wider spectrum of specialist and comprehensive clinical functionality, which increases overall compliance with NHS best practice.

The NHS’s mandate to improve the healthcare system by 2020 is underpinned by the need for the effective use of technology. By using Silverlink’s PCS PAS technology, Trusts have shown that they can meet this mandate and lay the foundation for advanced frameworks that can be used across acute, community, mental health, ambulance and social care settings.

Orion Health announces global launch of Amadeus

9th December 2015

Orion Health, the global technology company at the forefront of the revolution in healthcare, is firing up its offering by launching Amadeus, a platform that will enable highly personalised healthcare and the implementation of Precision Medicine.

CEO Ian McCrae says Amadeus is at the forefront of Precision Medicine – the newest frontier in modern healthcare.

Precision Medicine is enabled when all information unique to an individual is combined to identify preventative care and treatments, which will be effective for them based on genetic, environmental and lifestyle factors,” says Mr McCrae.

Today many factors impact health outcomes, yet currently, only a few will be taken into account when healthcare decisions are being made. Amadeus will enable doctors to get the insights they need to help them make accurate diagnoses and provide the optimal treatment,” he says.

In addition, patients will increasingly have the information they need to be active participants in their own healthcare.

Amadeus is a secure open-data platform that scales to aggregate and manage different types of health-related data. Orion Health has evolved its industry-leading population health management platform to accommodate huge data file sizes, including genomic (the genetic makeup of the patient) information.

What is particularly exciting is that we are delivering Amadeus as an open platform, upon which third parties can innovate. The platform’s APIs (Application Program Interfaces) will enable third-party applications to have access to rich data and services so that they can provide additional services that will benefit both doctors and their patients,” says Mr McCrae.

Patient privacy is of paramount importance, which is why Amadeus features an advanced privacy service that provides granular access to data elements based on user roles and the sensitivity of the data.

EVP EMEA Wayne Oxenham believes that Precision Medicine will dramatically change healthcare as we know it today.

Current models of care delivery focus on applying treatments to conditions, not individuals. The consequence of that “one size fits all” approach is that individuals don’t receive treatments that take into account factors that make them unique – their family and clinical history, environmental and social factors, and importantly their genome, which when combined with their clinical information can reveal treatment and prevention strategies right for them,” says Oxenham.

Amadeus combines Orion Health’s extensive data integration experience with the scalability and performance of its modern technologies Cassandra™, Spark™ and ElasticSearch™. It has a distributed architecture to handle massive volumes of high velocity data.

The modern data platform incorporates predictive modelling to identify the most at-risk patients in a population to drive rapid decision-making, and will leverage machine learning to make predictions on its immense data.

Orion Health is already making strides into Precision Medicine and last week joined up with fellow New Zealand medical technology company Medtech and Computer Sciences Corporation (CSC) to work together to deliver a world-leading Precision Medicine solution for New Zealand.

McCrae says that Amadeus goes beyond delivering the technology for today’s integrated care and population health management needs – it future-proofs organisations for emerging models of care.

This is a critical evolution of our business, and for healthcare generally. Imagine a world where everyone receives the treatment that’s perfect for them. That’s what we’re aiming for,” says Mr McCrae.

Takeda presents data from Phase III TOURMALINE-MM1 study for NINLARO®

7th December 2015

Takeda Pharmaceutical Company Limited announced results from the TOURMALINE-MM1 trial presented at the 57th Annual Meeting and Exposition of the American Society of Hematology (ASH), showing that treatment with Ninlaro® (ixazomib) capsules is effective in extending progression free survival (PFS) with a manageable tolerability profile in patients with relapsed and/or refractory multiple myeloma.

The TOURMALINE-MM1 trial is an international, randomised, double-blind, placebo-controlled Phase III clinical trial designed to evaluate once-weekly oral ixazomib plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone.

Ninlaro was recently approved by the US Food and Drug Administration (FDA) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The approval was based on the Phase III TOURMALINE-MM1 data, which were highlighted at the ASH press briefing. Ixazomib data will be featured in 18 presentations at this year’s ASH meeting, including an oral presentation on Phase II data from an investigational study evaluating the all-oral combination of ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) in newly diagnosed multiple myeloma patients.

The data presented at ASH this year are the first major output from the comprehensive ixazomib clinical trial program, TOURMALINE, demonstrating Takeda’s ongoing commitment to providing effective and convenient treatment options for patients with multiple myeloma,” said Andy Plump, MD, PhD, Takeda Chief Medical and Scientific Officer. “The breadth and depth of the TOURMALINE programme allows us to gather important data across a broad range of patients that live with multiple myeloma and to expand on the efficacy and safety profile of our oral proteasome inhibitor, ixazomib. We will continue this and other important clinical trials and look forward to sharing results over the next few years.

The comprehensive ixazomib clinical development program, TOURMALINE, includes a total of five pivotal trials – four investigating every major multiple myeloma patient population and one in light-chain amyloidosis.

Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in Combination with Lenalidomide and Dexamethasone (IRd), Significantly Extends Progression-Free Survival (PFS) for Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (RRMM): The Phase III Tourmaline-MM1 Study  (Abstract #727).

TOURMALINE-MM1 (n= 722) is the first double-blind, placebo-controlled trial with a proteasome inhibitor and has met the primary endpoint at the first interim analysis. Trial results demonstrate a statistically significant (35%) improvement in PFS, with patients treated in the ixazomib arm living for a significantly longer time without their disease worsening compared to patients in the control arm (20.6 months versus 14.7 months in control group; Hazard Ratio [HR] 0.742; p=0.012). Overall response rate (ORR) was 78.3% in the ixazomib arm and median duration of response was 20.5 months, versus 71.5% and 15 months in the control group. Median PFS in high-risk patients (HR 0.543; HR 0.596 in patients with del(17p)) was similar to that in the overall patient population and in standard-risk patients. Adverse events observed with IRd were consistent with reported safety profiles for the individual agents. The most common gr ≥3 adverse events included neutropenia, anaemia, thrombocytopenia, and pneumonia. Gastrointestinal events included diarrhoea, nausea, and vomiting. Peripheral neuropathy (PN) rates were 28% in the IRd arm versus 21% in the control arm, 35% vs. 21% had rash events, 8% versus 10% had acute renal failure, and 4% versus 3% had heart failure.

The TOURMALINE-MM1 trial evaluated ixazomib plus lenalidomide and dexamethasone in some of the most common patient types in the relapsed/refractory multiple myeloma setting who are in urgent need of new treatment options due to the complex nature of this disease. This trial enabled us to gather efficacy and safety data across a large variety of patients such as older patients, patients with moderate renal impairment, light chain disease, and high risk cytogenetics,” said lead investigator and presenter Philippe Moreau, MD, University of Nantes, France.

The TOURMALINE-MM1 trial is currently ongoing. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes.

Takeda has submitted additional review applications for ixazomib to regulatory authorities around the world, including the European Medicines Agency (EMA), based on the TOURMALINE-MM1 data.