Latest news with #Kuykendall
Medscape
6 days ago
- Business
- Medscape
Rusfertide: First Self-Injected Drug to Cut Phlebotomy
Rusfertide, an investigational, first-in-class, self-injected peptide targeting the hepcidin pathway, shows efficacy in significantly reducing the need for phlebotomy in patients with polycythemia vera (PV) while improving quality-of-life symptoms, potentially representing an important new standard of care for the commonly undertreated condition. 'Rusfertide is the first agent to prospectively demonstrate a statistically significant improvement in the PROMIS Fatigue SF-8a and MFSAF patient-reported outcomes in patients with PV,' said lead investigator Andrew Tucker Kuykendall, MD, of the Moffitt Cancer Center, in Tampa, Florida, in presenting the findings at American Society of Clinical Oncology (ASCO) 2025 annual meeting. 'Rusfertide had a safety and tolerability profile consistent with rusfertide in prior studies.' In PV, characterized by the overproduction of red blood cells, patients have an increased risk for thromboembolic events, along with symptoms ranging from pruritus, night sweats, difficulty concentrating and fatigue. Patients with PV, characterized by an overproduction of blood cells in bone marrow, are at an increased risk for cardiovascular and thrombotic events, while also experiencing symptoms including potentially severe fatigue. The traditional standard treatment includes phlebotomy to reduce excess red blood cells, and patients also often receive cytoreductive agents, mainly hydroxyurea, but also including interferon alfa-2b, ruxolitinib, and busulfan. Despite those efforts, the treatment is often not sufficient in achieving or maintaining hematocrit control of < 45%, which is recommended to reduce the risk for a thromboembolic event. Furthermore, phlebotomy is not just burdensome in requiring reliance of the health system, but the treatment can exacerbate iron deficiency, posing further quality of life issues. If achieved, however, maintaining hematocrit control is associated with as much as a fourfold decreased risk for major events, Kuykendall explained. Rusfertide, a hepcidin-mimetic compound, is meanwhile designed to mimic endogenous hepcidin, key in regulating levels of iron in the body. With the drug showing favorable hematocrit control in the phase 2 REVIVE study, Kuykendall conducted the phase 3, double-blind VERIFY trial, enrolling 293 patients who required frequent phlebotomy, with or without stable cytoreductive therapy to control hematocrit. The patients were randomized to treatment either with once-weekly rusfertide (n = 147) or placebo (n = 146) for the first 32 weeks of the study. All who completed that phase were eligible to join the open-label rusfertide phase from weeks 32 to 52. About half of the patients in the study were treated with cytoreductive therapies to prevent thrombotic events. In weeks 0 through 32, 56.5% of patients in the rusfertide group and 55.5% in the placebo group received concurrent cytoreductive therapy. During the period from weeks 20 to 32, as many as 76.9% of patients receiving rusfertide achieved a clinical response compared with 32.9% of those who had received placebo ( P < .0001). During weeks 0-32, those receiving rusfertide had a mean number of 0.5 phlebotomies vs 1.8 with placebo ( P < .0001). As many as 72.8% of patients in the rusfertide group required no phlebotomies during the first 32 weeks compared with only 21.9% in the placebo group. Of note, the responses were consistent across subgroups, including based on level of risk or the type of concurrent cytoreductive therapy. 'Rusfertide reduced the mean number of phlebotomies vs placebo in weeks 0 through 32 by a statistically significant margin across subgroups, including PV risk category, geographic region and the use of concurrent cytoreductive therapy,' Kuykendall said. For the key secondary endpoint, 62.6% of patients in the rusfertide group were able to successfully maintain hematocrit below 45% from weeks 0 to 32 compared with just 14.4% of those in the placebo group ( P < .0001). Patients treated with rusfertide also demonstrated statistically significant improvement in measures of fatigue and other symptoms, as assessed on the PROMIS Fatigue SF-8a total T-score and MFSAF Total Symptom Score ( P < .03). The most common treatment-emergent adverse events (AEs) in the rusfertide and placebo groups, respectively, were injection site reactions (55.9% and 32.9%), anemia (15.9% and 4.1%), and fatigue (15.2% and 15.8%). Serious AEs occurred in 3.4% of those on rusfertide and 4.8% of patients on placebo; however, none were considered related to rusfertide treatment. Importantly, cancer events were reported in just 1 patient on rusfertide and 7 patients on placebo. Kuykendall noted that ongoing research will evaluate longer-term outcomes. 'Given this chronic malignancy, we are very focused on more long-term treatment outcomes such as transformation, safety as well as thrombosis, and ultimately we'll have to follow patients in this ongoing study during [subsequent phases] to see how these play out,' he said. 'Rusfertide demonstrated a manageable safety profile; it was consistent with prior studies, and based on this data we believe it represents a potential new treatment option for polycythemia vera,' Kuykendall added, noting that 'these data will ultimately be used to file marketing authorizations throughout the world.' Reduction of Phlebotomy 'Highly Important' to Patients Commenting on the study at the meeting, discussant Katherine Walsh, MD, an associate professor of medicine in the Division of Hematology and Oncology, Vanderbilt University Medical Center, in Nashville, Tennessee, called the results 'practice changing,' agreeing that 'rusfertide should become a standard of care for us for our patients in the near future.' 'The ability to reduce the need for phlebotomy, which can carry a heavy burden, causing severe fatigue, visual disturbances and iron deficiency, is a highly important goal for patients with PV,' she explained. 'These patients live with a high risk of thrombosis over time and that has significant impact on their survival, impact on quality of life, and can be fatal in and of itself from those thrombotic events.' In discussing further potential benefits, Kuykendall noted that rusfertide is of interest to patients who may not be responding well to cytoreductive therapy. 'I think our cytoreductive therapy options are limited in what they can offer to patients,' he noted in discussion of the study. 'They certainly reduce thrombotic events, they can control some blood counts, but they do have long term side-effect profile issues, tolerability issues and they don't do as much as I would like for patients on in terms of quality of life,' he added. 'So I think this is where we can add to our current cytoreductive therapies that brings something else to the table.' Walsh agreed, noting that 'I have a number of patients who are referred because they don't want to go on a cytoreductive agent if they can avoid it, and I think having this option with this different mechanism of action will be appealing to [those] patients wanting to avoid cytoreduction.' Adding to the Chorus of Support for New Standard of Care Further commenting on the study in an ASCO Daily News report, Julie Gralow, MD, ASCO's chief medical officer, noted the importance of the cancer results. 'We know that acute myeloid leukemia (AML) and other malignancies can occur in patients with polycythemia,' she explained. 'AML occurs in about 3% of these patients over 10 years.' 'With just one cancer in the rusfertide group, and seven in the placebo arm, [AML] clearly did not increase and may, although not significantly, have decreased.' Considering the reductions in the need for phlebotomy and other benefits, Gralow agreed that 'this really should become a new standard of care for patients who are requiring phlebotomy that have polycythemia.'
Yahoo
28-03-2025
- Business
- Yahoo
Leaders in Career, Technical Education encourages school districts to maintain strong programs amid budget shortfalls
EL PASO, Texas (KTSM) — Leaders in Career and Technical Education (CTE) encourage local school districts to seek their support amid funding issues and to continue providing students ample access and resources to CTE training. Canutillo ISD recently approved a move to make district-wide staff and program cuts to address a nearly $6 million shortfall. One of those cuts will involve the district's CTE Department. Canutillo ISD moves forward with staff layoffs, program cuts Gustavo Reveles, CISD's communications director, said they will be able to continue providing all of their CTE courses, but they had to significantly reduce the department's administration to make it work. 'Our CTE funding has been reduced by the state. CTE courses — which includes engineering, healthcare, law enforcement and other career preparation classes — are an important part of our offerings. To offset the reduction in funding and retain all course offerings, we have made the decision to eliminate a central office position in the CTE Department,' Reveles said. 'Additionally, the remaining CTE administrator will be moved to Canutillo High School, where he will be better able to serve the majority of the students in CTE courses,' Reveles added. CEO for Western Technical College, Brad Kuykendall, said they already have a partnership with Anthony, Tornillo, and Socorro ISD. The three districts send their students under a dual enrollment program to Western Tech to learn under their instructors in different trades programs, while also obtaining credit for high school and college. 'I know the school districts are in difficult positions where they're having to make cuts in areas where they may not want to, but they're being forced to. I would say we have to think outside the box,' Kuykendall said. 'Students that come to us from a variety of school districts get experience with the wide array of equipment we have. Whether it's automotive, HVAC & refrigeration, physical therapist assistants, nursing, welding. All of these trades programs that we have can go to support that. We have an excess capacity of resources in the afternoon. And so, if we can set up an agreement with the school district where students can come in the afternoon, we already have teachers as resources, we have equipment as resources. I think that can help to solve some of the budget shortfalls that the school districts are working on.' Data from the Texas Workforce Commission shows that many CTE occupations are projected to be in high demand in the Borderplex through 2032, namely registered nurses and software developers. Borderplex-WDA-CTEDownload 'The trade jobs in particular and technical jobs that we go with, they're middle skill trade jobs that go to support the entire industry. When the COVID-19 Pandemic occurred, the essential jobs that were crucial for continuing the economy and supporting us that were working from home were the trade and skill jobs,' Kuykendall said. Scott Herndon, director and owner of Sun City Welding Academy, agreed with Kuykendall that the trades workforce is essential to the Borderland, and is a vital alternate career path for many students who don't want to pursue the traditional university route. 'A lot of our graduates are graduating debt-free because of the payment plans that we offer. They graduate, they get out there, and they find a job. We can't graduate them fast enough. Skilled tradesmen are essential to this region,' Herndon said. Herndon said that while there are many opportunities out in El Paso for students to seek a CTE education, he said it is crucial for local public schools to continue to offer that first experience and intrigue for students who are still unsure of what career to pursue. 'High school is where it starts. Getting them young, where they have that open mind. Capturing them early, getting them intrigued and showing them that there's a future in welding, where they can actually start researching and exploring what welding can do for them, and that's where we come in,' Herndon said. Meanwhile, Kuykendall urged state legislators to reconsider how their decisions affect regions like the Borderland. 'At a time when there's a significant amount of budget shortfalls, I think there needs to be a balance of accountability for those budgets, but also ensuring that we have the support. We're already in a socio-economically disadvantaged area,' Kuykendall said. 'Ample consideration needs to be given to properly fund and budget many of these initiatives that we have. Otherwise, our region is going to continue to fall behind in terms of funding, in terms of education, in terms of training, and in terms of overall opportunity. We need to provide the opportunity, and we need to make sure that those opportunities are kept here within the Borderplex region to support us.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
