On Memorial Day, we should also remember, honor veterans who died from war-related causes
In this May 2020 photo, flags are placed at each gravesite at the Idaho State Veterans Cemetery in Boise to honor veterans for Memorial Day. ()
Memorial Day is a time to set aside our differences and join together in remembering and thanking those brave souls who gave their last full measure for their fellow Americans. They deserve that honor even for serving in what some thought to be an ill-advised conflict. Vietnam turned out to be such a war, but that cannot take away from the fact that the 58,220 service personnel who died in that war were answering the call of their country and doing it well.
On Memorial Day, we think of the almost 1,355,000 service personnel who have perished in the nation's conflicts, starting with the 70,000 who died in the Revolutionary War. Since then, about 655,000 died on both sides of the Civil War. The death toll in World War I was 116,516, and 406,399 died in World War II. The vicious and almost forgotten Korean War saw 36,574 deaths. After Vietnam, 2,325 died in the War in Afghanistan and 4,492 in the Iraq War. May they all rest in peace.
But there are others we should hold in our hearts in addition to those who died in the war theaters. War has a way of inflicting mortal injuries that only take their toll on veterans after the guns are silenced. They include illnesses caused by exposure to toxins, like poisonous gas in WWI, Agent Orange in Vietnam and burn pit fumes in the Gulf War, Afghanistan and Iraq. Those toxins have resulted in untold deaths from a variety of cancers and other diseases. They are not counted on the official death tallies, but they nevertheless are directly attributable to combat conditions.
Many veterans have experienced health problems attributable to wartime conditions or know of others who have. It has been estimated that about 300,000 Vietnam veterans have died because of exposure to Agent Orange. The late Dan Eismann, my colleague of 12 years on the Idaho Supreme Court, received substantial exposure to Agent Orange during two tours in Vietnam. While on the ourt, he developed non-Hodgkin lymphoma and metastatic melanoma, passing away with honor last year.
I was also exposed during my Vietnam service and developed pancreatic cancer in 2017. With surgery, chemo and a great deal of luck, I've been cured.
More recently, about 60,000 veterans of the Iraq and Afghanistan wars are suffering and dying from medical ailments caused by exposure to toxins emanating from burn pits used to destroy all sorts of trash. Congress finally passed the PACT Act in 2022 to provide the necessary medical care, but the act has not been funded for the current fiscal year. That is a serious breach of the country's duty to those veterans.
There are many other serious problems that our veteran community faces on an all-too-frequent basis, including mental health issues, chronic substance abuse, suicide, traumatic brain injury and post-traumatic stress. There is obviously a lot of intermingling of these problems, but they present serious issues for many veterans.
While we can only honor the memories of the veterans who died in war zones, everyone concerned about our living veterans can take action to address problems presently confronting them. That could help to prevent future war-related deaths. When we see veterans in distress, we can reach out to them, provide a voice of caring and make a referral to a helpline for expert assistance.
Everyone can provide a service to our community of living veterans by speaking out on their behalf in public. We should inform members of our congressional delegation, as well as state and local leaders, that we expect them to advocate for preserving and protecting veterans and the benefits they have rightfully earned.
The message must be that we will not put up with massive cuts of medical and support staffing at VA medical facilities. The lives and health of our veteran population must not be sacrificed based on unsupported claims of wasteful spending in veterans programs.
Our senators and congressmen should take aggressive action to maintain the current level of VA spending and to ensure funding of the PACT Act in the current budget fight. Funding must be restored for important programs designed to halt the war-related deaths of our veterans, including lifesaving cancer trials, mental health care, and suicide prevention.
These essential programs, along with many others, must be restored, stabilized and adequately funded, in order to address war-related injuries and illnesses in our veteran population. They deserve nothing less.
On Memorial Day, May 26, let's remember, honor and mourn those gallant Americans who gave their lives in service to this great country. We should also pay tribute to the veterans who died off of the battlefield because of war-related causes. And let's resolve to do our utmost to prevent future loss of life for that veteran population.
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By GlobeNewswire Published on June 12, 2025, 11:00 IST In the Phase IIIB APPULSE-PNH study, adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who switched to Fabhalta experienced clinically meaningful improvements in hemoglobin (Hb) levels of 2.01 g/dL on average 1,2 APPULSE-PNH evaluated Fabhalta in a population with higher baseline hemoglobin (Hb) levels than those enrolled in the pivotal Phase III program, expanding the clinical evidence base 1 ,2 No patients treated with Fabhalta required transfusions, experienced breakthrough hemolysis (BTH) or had any major adverse vascular events during the treatment period 1 Patients treated with Fabhalta reported an average improvement in fatigue from baseline of 4.88 points at Day 84 and 4.29 points at Day 168 of the study (as measured by FACIT-Fatigue score) 1 Basel, June 12, 2025 – Novartis announced positive results from APPULSE-PNH, a Phase IIIB study evaluating the efficacy and safety of twice-daily oral monotherapy Fabhalta® (iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) with Hb levels ≥10g/dL who switched from anti-C5 therapies (eculizumab or ravulizumab)1. After 24 weeks of treatment with Fabhalta, the Hb level improved on average by 2.01 g/dL (95% CI, 1.74, 2.29) with most patients achieving normal or near-normal levels 1. Data will be presented at the European Hematology Association (EHA) Congress 2025. 'Today, some patients living with PNH have unmet needs not addressed by eculizumab or ravulizumab,' said Austin Kulasekararaj, Consultant Hematologist, Kings College Hospital and Kings College London. 'The positive results from APPULSE-PNH reinforce that Fabhalta can provide clinically meaningful improvements in hemoglobin among patients with higher baseline hemoglobin levels than those enrolled in previous trials, while offering an oral monotherapy for patients.' No patients required transfusion during the study, and the vast majority (92.7%) achieved Hb ≥12g/dL, reaching normal or near-normal levels1. Patients treated with Fabhalta also reported clinically meaningful improvements in fatigue (as measured by FACIT-Fatigue score) through Day 168, reaching absolute levels similar to those reported in the general population1,3,4. Furthermore, patients treated with Fabhalta maintained intravascular hemolysis control and resolved extravascular hemolysis control, as demonstrated by lactate dehydrogenase levels (<1.5 upper limit of normal) and a reduction in absolute reticulocyte count1. 'Novartis is dedicated to advancing research and innovation that can transform care and significantly improve the lives of people living with PNH and those who support them,' said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. 'New data from APPULSE-PNH, combined with findings from the Phase III roll-over extension of the APPLY-PNH and APPOINT-PNH studies, reinforce the efficacy and safety profile of Fabhalta in delivering real benefits to patients. Fabhalta is the first and only oral monotherapy currently available for the treatment of adults with PNH, regardless of previous treatment experience.' Alongside APPULSE-PNH, longer-term data from patients initially included in the APPLY-PNH and APPOINT-PNH Phase III studies will be presented at EHA1. In APPULSE-PNH and the Phase III roll-over extension study of the APPLY-PNH and APPOINT-PNH studies, Fabhalta was well-tolerated with no new safety signals, consistent with previously reported data1,5. About paroxysmal nocturnal hemoglobinuria (PNH) PNH is a rare, chronic and serious complement-mediated blood disorder6. People with PNH have an acquired mutation in some of their hematopoietic stem cells (which are located in the bone marrow and can grow and develop into red blood cells [RBCs], white blood cells and platelets) that causes them to produce RBCs that are susceptible to premature destruction by the complement system6,7. This leads to intravascular hemolysis (destruction of RBCs within blood vessels) and extravascular hemolysis (destruction of RBCs mostly in the spleen and liver), which cause anemia (low levels of circulating RBCs), thrombosis (formation of blood clots), fatigue and other debilitating symptoms6,7. It is estimated that approximately 10-20 people per million worldwide live with PNH6. Although PNH can develop at any age, it is often diagnosed in people between 30-40 years old8,9. PNH has a significant unmet need not addressed by anti-C5 therapies (eculizumab or ravulizumab). Anti-C5 therapies (eculizumab or ravulizumab) are commonly administered every 2-8 weeks as intravenous infusions, and treatment visits (including journey, waiting, infusion and recovery time) can take approximately 4 to 5 hours10. Despite treatment with anti-C5 therapies, a large proportion of people with PNH remain anemic, and some dependent on blood transfusions7,11–16. About APPULSE-PNH APPULSE-PNH (NCT05630001) is a Phase IIIB, multinational, multicenter, single-arm, open-label study to evaluate the efficacy and safety of twice-daily oral Fabhalta® (iptacopan) monotherapy (200mg) in adults with PNH who were switched from anti-C5 therapies (eculizumab or ravulizumab)2. The trial enrolled 52 participants who received Fabhalta for 24 weeks2. Participants enrolled were required to be on a stable regimen with anti-C5 therapies (eculizumab or ravulizumab) for at least 6 months prior to screening with average hemoglobin (Hb) ≥10g/dL and no red blood cell transfusions in this period2,17. The primary endpoint is change from baseline Hb levels after 24 weeks of treatment with Fabhalta2,17. About APPLY-PNH APPLY-PNH (NCT04558918) is a Phase III, randomized, multinational, multicenter, active-comparator controlled, open-label trial to evaluate the efficacy and safety of twice-daily, oral Fabhalta® (iptacopan) monotherapy (200mg) for the treatment of PNH by demonstrating the superiority of Fabhalta compared to anti-C5 therapies (eculizumab or ravulizumab) in adult patients presenting with residual anemia (Hb <10 g/dl) despite a stable regimen of anti-C5 treatment in the last six months prior to randomization5,18. About APPOINT-PNH APPOINT-PNH (NCT04820530) is a Phase III, multinational, multicenter, open-label, single-arm study to evaluate the efficacy and safety of twice-daily, oral Fabhalta® (iptacopan) monotherapy (200mg) in adult PNH patients who are naïve to complement inhibitor therapy, including anti-C5 therapies (eculizumab or ravulizumab)19,20. About Fabhalta® (iptacopan) Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway21,22. Discovered at Novartis, Fabhalta received US Food and Drug Administration (FDA) and European Commission (EC) approval in December 2023 and May 2024 respectively for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) and accelerated approval in the US in August 2024 for the reduction of proteinuria in adults with primary IgA nephropathy (IgAN) at risk of rapid disease progression (generally UPCR ≥1.5 g/g 1.5 g/g)1,23,24. In 2025, Fabhalta received FDA and EC approval for the treatment of adults with C3 glomerulopathy (C3G) to reduce proteinuria, making it the first and only treatment approved for this condition25–31. Fabhalta is being studied in a broad range of rare kidney diseases, including atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN). Studies are ongoing to evaluate the safety and efficacy profiles in these investigational indications and support potential regulatory submissions32-35. Disclaimer This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'plan,' 'may,' 'could,' 'would,' 'expect,' 'anticipate,' 'look forward,' 'believe,' 'committed,' 'investigational,' 'pipeline,' 'launch,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Novartis. Data on file. NCT05630001. Single Arm, Open Label Trial With Iptacopan Treatment for 24 Weeks, in Patients on Stable Regimen of Anti-C5 Who Switch to Iptacopan. (APPULSE). Available from: Accessed May, 2025. Montan I, Löwe B, Cella D, Mehnert A, Hinz A. General Population Norms for the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale. Value Health. 2018;21(11):1313-1321. doi:10.1016/ Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer. 2002;94(2):528-538. doi:10.1002/cncr.10245 Peffault de Latour R, Röth A, Kulasekararaj AG, et al. Oral Iptacopan Monotherapy in Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2024;390(11):994-1008. doi:10.1056/NEJMoa2308695 Cançado RD, Araújo ADS, Sandes AF, et al. Consensus statement for diagnosis and treatment of paroxysmal nocturnal haemoglobinuria. Hematol Transfus Cell Ther. 2021;43(3):341-348. Dingli D, Matos JE, Lehrhaupt K, et al. The burden of illness in patients with paroxysmal nocturnal hemoglobinuria receiving treatment with the C5-inhibitors eculizumab or ravulizumab: results from a US patient survey. Ann Hematol. 2022;101(2):251-263. Hill A, DeZern AE, Kinoshita T, Brodsky RA. Paroxysmal nocturnal haemoglobinuria. Nat Rev Dis Primers. 2017;3:17028. Röth A, Maciejewski J, Nishimura JI, Jain D, Weitz JI. Screening and diagnostic clinical algorithm for paroxysmal nocturnal hemoglobinuria: Expert consensus. Eur J Haematol. 2018;101(1):3-11. Levy AR, Dysart L, Patel Y, et al. Comparison of Lost Productivity Due to Eculizumab and Ravulizumab Treatments for Paroxysmal Nocturnal Hemoglobinuria in France, Germany, Italy, Russia, Spain, the United Kingdom, and the United States. Blood. 2019;134(Supplement_1):4803. McKinley CE, Richards SJ, Munir T, et al. Extravascular Hemolysis Due to C3-Loading in Patients with PNH Treated with Eculizumab: Defining the Clinical Syndrome. Blood. 2017;130(Supplement 1):3471. Risitano AM, Marotta S, Ricci P, et al. Anti-complement Treatment for Paroxysmal Nocturnal Hemoglobinuria: Time for Proximal Complement Inhibition? A Position Paper From the SAAWP of the EBMT. Front Immunol. 2019;10:1157. Shammo J, Kim J, Georget M, et al. P796: Hospitalization in patients with paroxysmal nocturnal hemoglobinuria: a retrospective analysis of observational study data from the United States. Hemasphere. 2023;7(Suppl):e22585a2. Debureaux PE, Kulasekararaj AG, Cacace F, et al. Categorizing hematological response to eculizumab in paroxysmal nocturnal hemoglobinuria: a multicenter real-life study. Bone Marrow Transplant. 2021;56(10):2600-2602. Schrezenmeier H, Kulasekararaj A, Mitchell L, et al. One-year efficacy and safety of ravulizumab in adults with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy: open-label extension of a randomized study. Ther Adv Hematol. 2020;11:2040620720966137. Young NS, Meyers G, Schrezenmeier H, Hillmen P, Hill A. The management of paroxysmal nocturnal hemoglobinuria: recent advances in diagnosis and treatment and new hope for patients. Semin Hematol. 2009;46(1 Suppl 1):S1-S16. Risitano AM, Araten DJ, Kuter D, et al. Pb2063: APPULSE-PNH: A phase IIIB trial to evaluate the efficacy and safety of switching to iptacopan in patients with paroxysmal nocturnal hemoglobinuria (PNH) on anti-c5 therapy with hemoglobin >10g/dl. Hemasphere. 2023;7(Suppl):e08587b7. NCT04558918. Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment (APPLY-PNH). Available from: Accessed May, 2025. Risitano AM, Han B, Ueda Y, et al. Oral Complement Factor B Inhibitor Iptacopan Monotherapy Improves Hemoglobin to Normal/Near-Normal Levels in Paroxysmal Nocturnal Hemoglobinuria Patients Naïve to Complement Inhibitors: Phase III APPOINT-PNH Trial. Presented at: 49th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT); April 23-36, 2023; Paris, France. NCT04820530. Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy (APPOINT-PNH). Available from: Accessed May, 2025. Kavanagh D, Bomback A, Vivarelli M, et al. Efficacy and Safety of Iptacopan in Patients with C3 Glomerulopathy: Results from the Phase 3 APPEAR-C3G Trial. Presented at European Renal Association (ERA) Congress; May 25, 2024; Stockholm, Sweden. Smith RJ, Kavanagh D, Vivarelli M, et al. Efficacy and safety of iptacopan in patients with C3 glomerulopathy: 12-Month results from the Phase 3 APPEAR-C3G study. Presented at American Society of Nephrology (ASN) Kidney Week 2024; October 23-27, 2024; San Diego, CA. Novartis. Press release. Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH. Available from: Accessed May, 2025. Novartis. Press release. Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN). Available from: Accessed May, 2025. Novartis. Press release. Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G). Available from: Accessed May, 2025. Novartis. Press release. Novartis oral Fabhalta® (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy (C3G). Available from: Accessed May, 2025. Fabhalta®. US FDA Prescribing information. East Hanover, NJ:Novartis Pharmaceuticals Corp; 2024. Available from: Accessed May, 2025. Fabhalta®. EMA Summary of Product Characteristics. Novartis Europharm Limited; 2024. Available from: Accessed May, 2025. Martín B, Smith RJH. C3 Glomerulopathy. In: Adam MP, Feldman J, Mirzaa GM, et al, eds. GeneReviews® [Internet]. Seattle, WA: University of Washington, Seattle; 1993-2025. Updated April 5, 2018. Available from: Accessed May, 2025. Schena FP, Esposito P, Rossini M. A Narrative Review on C3 Glomerulopathy: A Rare Renal Disease. Int J Mol Sci. 2020;21(2):525. Caravaca-Fontán F, Lucientes L, Cavero T, Praga M. Update on C3 Glomerulopathy: A Complement-Mediated Disease. Nephron. 2020;144(6):272-280. NCT04578834. Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN). Available from: Accessed May, 2025. NCT04889430. Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy (APPELHUS). Available from: Accessed May, 2025. NCT05755386. Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN (APPARENT). Available from: Accessed May, 2025. NCT05268289. Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V. Available from: Accessed May, 2025. # # # Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
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Patients who met the AMPLIFY inclusion criteria from both the Phase 3 GLOW (NCT03462719) and Phase 2 CAPTIVATE (NCT02910583) studies were included in this analysis, and, after matching and balancing the treatment cohorts, comparative analyses between the trials suggested that I+V significantly reduced the risk of progression or death by 47 percent when compared to patients treated with A+V (hazard ratio [HR]: 0.53; 95 percent confidence interval [CI]: 0.33-0.85; p =0.0085).1,3,4,5 The results also suggested that patients treated with I+V were almost twice (95 percent CI: 1.47-2.41; p <0.0001) and 2.4 times (95 percent CI: 1.78-3.12; p <0.0001) more likely to achieve uMRD than A+V at EOT+3, in PB and BM, respectively.1 The GLOW and CAPTIVATE FD cohorts were based on individual patient-level data with a median follow-up of approximately 4.5 years, while the A+V cohort used aggregate level data from the AMPLIFY study with a median follow-up of approximately 3.4 years.1 Results from final analysis of CAPTIVATE Long-term follow-up results from the Phase 2 CAPTIVATE study data were presented as a poster at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting (Poster presentation #219) and will also be presented as an encore oral presentation at EHA 2025 (Oral presentation #S156).6 The data reinforced the durable clinical benefit of frontline I+V.2 Phase 2 CAPTIVATE results demonstrated patients in the I+V FD cohort displayed a clinically meaningful PFS and overall survival (OS) vs the MRD-guided cohort.2 After a median follow-up of 68.9 months, the 5.5-year PFS and OS rates for all treated patients were 66 percent (95 percent CI: 58-72) and 97 percent (95 percent CI: 93-99), respectively.2 Additionally, the 5.5 year PFS rate in patients who achieved uMRD in the PB at the EOT was 71 percent (95 percent CI: 60-80).2 Furthermore, 1-year PFS and OS rates from the start of retreatment (with single-agent ibrutinib or FD I+V) were both 100 percent, whilst 2-year PFS and OS rates from the start of retreatment were 91 percent and 96 percent, respectively.2 No new safety signals were observed during the CAPTIVATE study since the previous follow-up, with COVID-19, diarrhoea and hypertension being the most frequently reported adverse events (AEs).2 In the total pooled CAPTIVATE population, 32 percent (n=64/202) of patients had progressive disease following 5.5 years of follow-up.2 Of the 53 patients with available samples, none had acquired resistance-associated mutations in BTK or PLCG2 .2 'The final analysis of CAPTIVATE highlights how ibrutinib continues to raise the bar in the treatment of chronic lymphocytic leukaemia, with durable minimal residual disease response, extended treatment-free intervals, and a tolerable safety profile,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 'With the longest follow-up of any oral fixed-dose regimen, ibrutinib is setting a new standard for what patients and clinicians can expect from targeted therapies. We remain committed to advancing science in complex blood cancers and improving outcomes across the cancer care landscape.' 'The updates presented at EHA add to the growing body of evidence in support of ibrutinib, the most extensively studied Bruton's tyrosine kinase inhibitor, as the standard of care in the frontline treatment of chronic lymphocytic leukaemia,' said Jessica Vermeulen, Vice President, Lymphoma & Leukemia Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. 'Offering patients not only more time, but also the option for treatment-free remissions continues to be our goal and we are proud of the incredible contribution ibrutinib has made since its first European approval in 2014.' About the MAIC analysis The objective of this analysis was to compare the progression-free survival (PFS) and undetectable minimal residual disease (uMRD) data from the fixed-duration (FD) ibrutinib + venetoclax (I+V) cohorts from the Phase 3 GLOW (NCT03462719) and Phase 2 CAPTIVATE (NCT02910583) studies against the Phase 3 AMPLIFY (NCT03836261) data.1 In absence of prospective head-to-head trials investigating different Bruton's tyrosine kinase inhibitors (BTKis) plus B-cell lymphoma 2 (Bcl-2) strategies, this study utilised matching-adjusted indirect comparison (MAIC) to obtain useful insights on comparative efficacy.1 Individual patient data from the FD I+V cohorts of the GLOW and CAPTIVATE studies were pooled and compared to aggregate published Intent-to-Treat (ITT) data of the acalabrutinib plus venetoclax (A+V) arm of the AMPLIFY study.1,3,4,5 A MAIC was performed following method published by Signorovitch et al. and guidelines from the National Institute for Health and Care Excellence (NICE).1,7 Patients who did not meet the inclusion criteria of AMPLIFY were excluded from the I+V pooled cohort to establish the I+V patient population for analysis.1 The remaining I+V patients were then reweighted so that the average baseline characteristics of the pooled I+V cohort matched those of the A+V patients in AMPLIFY.1 The reweighted outcomes from I+V were then compared to the reported outcomes for A+V using indirect treatment comparison.1 Relative effects were quantified using relative risk (RR) and hazard ratios (HR) with 95 percent confidence intervals.1 There are potential sources of bias that cannot be accounted for in MAIC, that should be considered when interpreting such data. Specifically, in this comparison, the measurement of progression was stricter in GLOW and CAPTIVATE, requiring computer or magnetic imaging regardless of suspected progression and the median follow-up was longer in I+V population.1 Both may have biased the PFS results in favour of A+V.1 Additionally, AMPLIFY reported multicolour flow cytometry use but with no details on the number of colours and comparability is assumed with the 8-colour assay used in I+V studies.1 As in any non-randomised comparison there may be additional unreported clinically important prognostic patient baseline characteristics which cannot be accounted for.1 For example, Cumulative Illness Rating Scale score data was not collected in CAPTIVATE and therefore could not be used in matching.1 About CAPTIVATE The Phase 2 CAPTIVATE study ( NCT02910583 ) evaluated previously untreated adult patients with chronic lymphocytic leukaemia (CLL), who were 70 years or younger, including patients with high-risk disease, in two cohorts with combined median age of 60 years: a minimal residual disease (MRD)-guided cohort (n=43) and an FD cohort (n=159; median age).2,4,8 Patients in the FD cohort received three cycles of ibrutinib lead-in followed by 12 cycles of I+V (oral ibrutinib [420 mg/d]; oral venetoclax [five-week ramp-up to 400 mg/d]) and the primary endpoint was complete response rate.4 In the MRD cohort, after completion of three cycles ibrutinib lead-in followed by 12 cycles I+V, patients with confirmed uMRD were randomly assigned to double-blind treatment with placebo, or continuous ibrutinib.4 The primary endpoint was one-year disease-free survival.4 About the GLOW study The GLOW study ( NCT03462719 ) is a randomised, open-label, Phase 3 trial that evaluated the efficacy and safety of frontline, FD I+V versus chlorambucil plus obinutuzumab in adult patients with CLL who are (a) ≥65 years old, or (b) 18-64 years old with a Cumulative Illness Rating Scale score of greater than six or creatinine clearance less than 70 mL/min, who had active disease requiring treatment per the International Workshop on CLL criteria.3 About ibrutinib Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.9 Ibrutinib blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread.10 By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation.11 Ibrutinib is approved in more than 100 countries and has been used to treat more than 325,000 patients worldwide.12 There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib.10,13 In October 2021, ibrutinib was added to the World Health Organization's Model Lists of Essential Medicines (EML), which refers to medicines that address global health priorities and which should be available and affordable for all.14 Ibrutinib was first approved by the European Commission (EC) in 2014, and approved indications to date include:10 As a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated CLL As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy As a single agent for the treatment of adult patients with relapsed or refractory (RR) mantle cell lymphoma (MCL) As a single agent for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. In combination with rituximab for the treatment of adult patients with WM For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics . About Chronic Lymphocytic Leukaemia CLL is typically a slow-growing blood cancer of the white blood cells.15 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and it is about 1.5 times more common in men than in women (based on individuals diagnosed 2000-2002).16 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.17 While patient outcomes have dramatically improved in the last few decades, the disease is still characterised by consecutive episodes of disease progression and the need for therapy.18 Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.19 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Talha Munir, M.D., Consultant in Clinical Haematology at St James's Hospital, Leeds, United Kingdom, has provided consulting, advisory, and speaking services to Janssen-Cilag International NV; he has not been paid for any media work. 1 Munir T, et al., Cross-Study Comparison of Ibrutinib in Combination with Venetoclax (I+V) vs Acalabrutinib in Combination with Venetoclax (A+V) in Subjects with Previously Untreated Chronic Lymphocytic Leukemia (CLL). Poster presentation at 2025 European Hematology Association (EHA) Congress; June 12–15, 2025. [Poster PF587]. 2 Ghia P, et al. Final Analysis of Fixed-Duration Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) in the Phase 2 CAPTIVATE Study. Oral presentation at 2025 European Hematology Association (EHA) Congress; June 12–15, 2025. [Oral S156]. 3 A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (GLOW). Available at: Last accessed: June 2025. 4 Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) (CAPTIVATE). Available at: Last accessed: June 2025. 5 Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL (AMPLIFY). Available at: Last accessed: June 2025. 6 Ghia P, et al. Final Analysis of Fixed-Duration Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Phase 2 CAPTIVATE Study. Poster presentation at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025. [Poster #219]. 7 Signorovitch JE, et al. Matching-adjusted Indirect Comparisons: A New Tool for Timely Comparative Effectiveness Research. Value Health, 2012; 15: 940-947. 8 Jacobs R, et al., Outcomes in High-risk Subgroups After Fixed-Duration Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Up To 5.5 years of Follow-up in the Phase 2 CAPTIVATE Study. Poster presentation at 2024 European Hematology Association (EHA) Hybrid Congress; June 13–16, 2024. [Poster P675]. 9 European Medicines Agency. IMBRUVICA Summary of Product Characteristics. April 2025. Available at: Last accessed: June 2025. 10 Turetsky A, et al. Single cell Imaging of Bruton's tyrosine kinase using an Irreversible Inhibitor. Sci Rep. 2014; 4: 4782. 11 de Rooij MF, et al. The Clinically Active BTK Inhibitor PCI-32765 targets B-cell Receptor- and Chemokine-controlled Adhesion and Migration in Chronic Lymphocytic Leukemia. Blood. 2012; 119(11): 2590-2594. 12 J&J Data on File (RF-465355). Patients Treated on Imbruvica Worldwide. May 2025. 13 Pollyea DA, et al. A Phase I Dose Escalation Study of the Btk Inhibitor PCI-32765 in Relapsed and Refractory B Cell Non-Hodgkin Lymphoma and Use of a Novel Fluorescent Probe Pharmacodynamic Assay. Blood. 2009; 114(22): 3713. 14 World Health Organization. WHO Prioritizes Access to Diabetes and Cancer Treatments in New Essential Medicines Lists. Available at: Last accessed: June 2025. 15 American Cancer Society. What is Chronic Lymphocytic Leukemia? Available at: Last accessed: June 2025. 16 Sant M, et al. Incidence of Hematologic Malignancies in Europe by Morphologic Subtype: Results of the HAEMACARE project. Blood. 2010; 116:3724–34. 17 Eichhorst B, et al. Chronic Lymphocytic Leukaemia: ESMO Clinical Practice Guidelines for Diagnosis, Treatment and Follow-up Ann Oncol. 2021; 32(1): 23-33. 18 Moreno C. Standard Treatment Approaches for Relapsed/refractory Chronic Lymphocytic Leukemia after Frontline Chemoimmunotherapy. Hematology Am Soc Hematol Educ Program. 2020; 2020: 33-40. 19 Bewarder M, et al. Current Treatment Options in CLL. Cancers (Basel). 2021;13(10): 2468. CP-523458 June 2025 Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
