98 Clinical R&D
DARZALEX® (DARATUMUMAB) APPROVED FOR REIMBURSEMENT IN IRELAND Janssen, the Pharmaceutical Companies of Johnson & Johnson has announced Darzalex® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) has been granted reimbursement in Ireland for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The announcement follows EC approval of daratumumab based on results from Part one of the Phase 3 CASSIOPEIA (MMY3006) study, published in The Lancet5 in June 2019 and presented at the 2019 American Society of Clinical Oncology (ASCO) Meeting.
Professor Philip Murphy, Consultant Haematologist, Beaumont Hospital said, “For Irish patients newly diagnosed with multiple myeloma, the importance of early intervention with effective first-line treatments to maximise response cannot be emphasised enough. Improvements in the standard of care to provide patients with valuable extra time are vital. Data from the CASSIOPEIA study demonstrates that the addition of daratumumab in combination with VTd can lead to deep remissions and prolong PFS.” Dr Thorsten Giesecke, General Manager, Commercial Business, Janssen Sciences Ireland UC, said, “Janssen is committed to providing access for patients to daratumumab in earlier disease stages of multiple myeloma, a type of blood cancer that can have a devastating impact on the lives of those affected. Every year in Ireland about 350 people are diagnosed with this condition, and today’s reimbursement provides those who are newly diagnosed and transplant eligible, with a long-awaited additional frontline therapy.”6 The Phase 3 CASSIOPEIA trial is a two-part study. Results from this first part of the trial showed that after consolidation, the stringent complete response (sCR) rate was significantly higher in the daratumumab-VTd arm (29 percent) compared to VTd alone (20 percent) (Odds Ratio [OR] = 1.60; 95 percent confidence interval [CI], 1.21-2.12; P<0.0010).2 At a median follow-up of 18.8 months, PFS was significantly improved in the daratumumabVTd group compared to VTd alone (Hazard Ratio [HR] = 0.47; 95 percent CI, 0.33-0.67; P<0.0001), and the median PFS was not reached in either arm.2 The addition of daratumumab to VTd resulted in an 18-month PFS rate of 93 percent compared to 85 percent for VTd alone.2
The most common (≥10%) Grade 3/4 treatment-emergent adverse events (TEAEs) for daratumumabVTd and VTd, respectively, were neutropenia (28 percent vs. 15 percent), lymphopenia (17 percent vs. 10 percent), stomatitis (13 percent vs. 16 percent) and thrombocytopenia (11 percent vs. 7 percent).2 In the daratumumabVTd combination arm, infusionrelated reactions occurred in 35 percent of patients.2 91% OF IRISH ADULTS SUFFER FROM BACK PAIN Minister of State, Patrick O’Donovan, T.D., officially opened the new Spine Excellence clinic in Limerick, a collaboration between Mater Private Network and the Poynton Spine Care Institute, bringing advanced spine care directly to patients in Limerick and Munster. The new clinic is a centre of excellence delivering comprehensive assessment, diagnosis, treatment and rehabilitation of spine conditions. Spinal pain is a complex and multifactorial condition that is often poorly understood, incorrectly assessed, and inadequately treated. At Spine Excellence, the expert team have a deep understanding of all aspects of spinal pathology and work with patients to develop a bespoke plan. The extent to which Irish people suffer from back pain was made clear in a survey commissioned in conjunction with the official opening of the clinic. Conducted by Bounce Insights for Mater Private Network, the survey among 500 Irish adults (28% of whom were from the Munster region) Minister of State, Patrick O’Donovan TD with Spine Excellence Clinical Director and leading Irish spine surgeon, Mr. Ashley Poynton, David Slevin, Deputy Chief Executive of Mater Private Network
AUGUST 2022 • HPN | HOSPITALPROFESSIONALNEWS.IE
found that 91% of respondents suffered from back pain, while 46% reported missing either work or college because of their pain. Furthermore, 61% percent of respondents said they have visited their GP as a result of back pain and 53% said that their pain has impacted personal time with family and friends. Spine Excellence Clinical Director and leading Irish spine surgeon, Mr. Ashley Poynton, said, “I am incredibly proud of our team here at Spine Excellence. They will be able deliver a uniquely comprehensive approach to spine care in a stateof-the-art facility and rapid access to the Mater Private Network high tech spinal facilities in the Cork and Dublin hospitals, when needed. Our team has a broad and deep knowledge of spinal pathology from highly complex surgical cases to the most challenging rehabilitation patients and everything in between. “Most spinal pain can be treated successfully by regaining movement, flexibility, and strength, and building confidence in functional movement and exercise. While many people with spinal pain do not need any intervention other than rehabilitation, others may have underlying conditions that require deeper intervention, up to and including surgery. At Spine Excellence in Limerick, we have assembled an expert team, from specialist consultants and surgeons to spine expert physiotherapists to deal with all eventualities and all spinal pathologies. “Our philosophy is centred around the patient understanding the nature of the problem and building confidence in their own ability to recover.” David Slevin, Deputy Chief Executive of Mater Private Network, said, “Mater Private Network is delighted to deepen our collaboration with the Poynton Spine Care Institute through the establishment of Spine Excellence
in Limerick. Along with our hospitals in Cork and Dublin, we already have a presence in Limerick as the operator of the Mid-Western Radiation Oncology Centre at University Hospital Limerick. We understand how important it is to make best in class healthcare services more accessible to patients in the region. We are delighted to be part of Spine Excellence in Limerick with outstanding surgeons Mr. Ashley Poynton, Mr. Deb Roy, Mr. Islam Gawish along with the expert team.” GSK ON BEHALF OF VIIV HEALTHCARE LAUNCHES AND REKAMBYS VOCABRIA IN IRELAND
GSK Ireland on behalf of ViiV Healthcare is pleased to announce that eligible people living with Human Immunodeficiency Virus (HIV) in Ireland now have access to Vocabria (cabotegravir longacting injection) developed by ViiV Healthcare in combination with Rekambys (rilpivirine long-acting injection) developed by Janssen Sciences Ireland UC (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Vocabria and Rekambys is indicated for the treatment of HIV type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL), on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.1 This marks the first time that people living with HIV in Ireland can access a complete, longacting regimen once every two-months. This could reduce the number of days receiving treatment from 365 to 6 per year, when on the continuation injection phase of treatment. Professor Sam McConkey, Head of the Department of International Health and Tropical Medicine at the Royal College of Surgeons said: “Over the last 20 years great progress has been made in developing effective treatments for HIV that can suppress the virus in the body to undetectable levels, however until now it has required daily treatment. The introduction of a long-acting injectable treatment means that eligible people living with HIV will only need to be treated every two months, rather than every day. This approach has the potential to help lessen the burden of treatment and reduce the worry and stigma that comes with having to take treatments daily. We have used IM cabotegravir in the context of a phase III clinical trial in Ireland
