5-year follow-up from SEQUOIA study demonstrated treatment with BRUKINSA reduced the risk of progression or death by 71% compared to bendamustine-rituximab in patients with treatment-naïve CLL, further solidifying its position as the leader in new patient starts in both frontline and relapsed/refractory (R/R) CLL with the broadest label of any BTK inhibitor
At a median follow-up of 1.5 years, promising data from the 320 mg expansion cohort of phase 1/1b study shows no progression in patients with treatment-naïve CLL treated with sonrotoclax, a next-generation BCL2 inhibitor, in combination with BRUKINSA highlighting the potential of this fixed-duration, oral-only combination as a best-in-disease option
Data for BTK degrader BGB-16673 from phase 1/2 study highlight its potential in both treatment-resistant CLL and other B-cell malignancies representing high unmet needs
Arcellx(ACLX) stock reversed lower Monday despite positive results for its rival toLegend Biotech's (LGND) multiple myeloma treatment, Carvykti.
On Sunday, Arcellx said 97% of patients responded to treatment with its CAR-T drug, anito-cel, up from 95% in its prior data cut.
Across 86 patients that could be evaluated, 62% had complete responses — meaning all evidence of their cancer disappeared. And 93% of patients lived for six months before their cancer worsened. By a year, that number was 79%.
Leerink Partners analyst Daina Graybosch called the results a "best-case efficacy scenario."
She also noted that Arcellx's Gilead Sciences (GILD)-partnered anito-cel could be safer than Legend's Carvykti, developed in partnership with Johnson & Johnson (JNJ). There were no cases of Parkinsonism among anito-cel recipients. Parkinsonism refers to a group of neurological movement problems. It cropped up in a single-digit percentage of Carvykti patients in Legend's clinical studies.
Arcellx stock reversed lower, falling 1.9% to close at 82.95. That pulled back from a premarket gain of nearly 9%. Legend stock, on the other hand, rose a fraction, closing at 41.63.
Arcellx Stock: Rivaling Legend's Carvykti
The companies are bitter rivals in the multiple myeloma space. Over the weekend, Arcellx released the updated results from its anito-cel test at the same time Legend held an analyst meeting to discuss real-world use of Carvykti.
It's anyone's guess who will lead the space in the coming years.
Part of the problem stems from the differences in Arcellx's and Legend's studies. Legend seemingly enrolled sicker patients with Arcellx, analysts said. But Arcellx's CAR-T drug looks safer.
"We expect debates on patient selection and delayed neurotoxicity events are likely to take years to resolve," Leerink's Graybosch said in a client note.
The investment bank has an outperform rating on Arcellx stock.
Real-World Use Of Carvykti
During the Legend event, two doctors discussed real-world use of Carvykti.
Only one patient out of the roughly 200 they've treated with Carvykti has experienced Parkinsonism.
Management of cytokine release syndrome, or CRS, is also improving in the commercial world. CRS is an inflammatory condition that occurs when the immune system becomes overactive. CAR-T drugs involve stoking the immune system and, so, commonly cause CRS.
In Arcellx's study, CRS occurred in 83% of patients. Just 2% had serious events. That topped the 95% and 4%, respectively, in Legend's Carvykti studies. But, in the real world, academic centers and aligning on how to treat CRS, RBC Capital Markets analyst Leonid Timashev said in a report.
Timashev ultimately expects Carvykti to reach a peak $10 billion in sales. He expects $2 billion in sales next year, above Legend Biotech's own guidance for $1.9 billion.
He kept his outperform rating on Legend stock, but didn't list a rating for Arcellx stock.
Nestled in the mountains of Yancey County in western North Carolina, Burnsville looks like a town that might feature in a Norman Rockwell painting or a Hallmark Christmas movie.
Even before Thanksgiving, the town square was decorated for Christmas. Antique shops, cafes, and coffee houses dot Main Street, bustling with activity. On the surface, it appears to be a typical holiday season, but all is not as it seems. Two months after Hurricane Helene struck the region, Burnsville and Yancey County are still on a long path to recovery.
Crystal Capps, a real estate agent whose family has lived in Yancey County for several generations, said immediate and long-term assistance is essential for ensuring locals’ safety and enabling them to remain in the region.
“There is a sense of urgency. Winter weather is here. People are tough in these mountains, but it’s cold— too cold for people to be sleeping in tents and in their cars,” Capps told The Epoch Times. “I saw houses floating down the river when Helene hit. I’ll never forget that. For those who survived but are displaced, they need help.”
Capps is one of several Burnsville natives, including many friends from Mountain Heritage High School, who serve on the board of the Appalachian Disaster Coalition.
“We have a lot of work to do, but we have hope, and we are doing all we can to give hope to people who are struggling,” she said.
Bradley Honeycutt was born and raised in Yancey County. His parents live on a 48-acre mountainside property and have cattle and horses.
Honeycutt helped start the Appalachian Disaster Coalition just days after the storm. He was born and raised here and graduated in 2006 from Mountain Heritage High School.
Helene made landfall in Florida’s Big Bend region on Sept. 26 as a Category 4 hurricane. It left a swath of destruction throughout the Southeast extending to western North Carolina and eastern Tennessee.
Raging floodwaters and landslides from Hurricane Helene reached western North Carolina on Sept. 27, devastating urban and rural communities and severely damaging roads, homes, and power sources.
Just before Helene hit, storms drenched Asheville and surrounding western North Carolina towns when a weather front stalled over the Appalachian Mountains. Some areas received more than a foot of rain, saturating the land before Helene arrived.
Hundreds of roads were blocked or completely washed away, requiring rescue crews to reach victims by mule, horseback, and on foot. Search and rescue efforts, and delivery of supplies, were challenging because many residents who live on a mountainside only have one way in and one way out.
Honeycutt heard about what was happening in western North Carolina on the news. He tried to reach his parents all day on Sept. 27.
Finally, a cousin connected a Starlink terminal to a generator, enabling internet access, and contacted him through Facebook Messenger, he told The Epoch Times.
“It’s really bad,” he was told. “We don’t know what the rest of the county looks like, and we have not heard from your mom and dad,” his cousin said.
Honeycutt booked a flight to Charlotte and arrived at his parents’ property on Sept. 28.
“They weren’t there when I got to the house. I knew they were safe because the generators were running and the lights were on. When they pulled into the driveway, we hugged and talked for around an hour. Then I said, ‘I gotta go and see what I can do.’” he said.
Honeycutt contacted friends who had experience with search and rescue after disasters. They traveled to Yancey County to help.
Friends in Dallas, where he is finishing a degree in architecture and design with the intent to return to Burnsville and open a business, established social media accounts under the name “Bradley Loves Burnsville.”
The accounts gained followers, and Honeycutt outlined the area’s immediate needs to them.
“We needed propane. We needed gas. Before we knew it, a tanker with 11,000 gallons of gas arrived. Necessities and other items like generators started coming in. It was chaos,” Honeycutt said. “There was no outside communication since cell phones didn’t work. No water. No power. It was dark, and we were on our own.”
Recognizing immediate and long-term needs for temporary and permanent housing, and trauma therapy, Honeycutt established an incorporated nonprofit called Appalachian Disaster Coalition.
The current priority is getting displaced residents into campers and temporary homes, Honeycutt said. The group has partnered with other nonprofits to expand their capabilities. Eventually, they plan to build 30 three-bedroom, two-bath, single-family homes for locals in Yancey County.
Appalachian Disaster Coalition and other independent groups are important in ensuring the town isn’t forgotten, Honeycutt said.
Change is finally coming to America’s failing healthcare system.
If RFK Jr. is confirmed as Secretary of Health and Human Services (HHS), the Trump administration is set to truly shake things up for the first time in modern history.
HHS is a gigantic beast, with 13 divisions under its roof including the FDA, CDC, CMS, and NIH.
CMS’ Medicare spending alone reached over $840 billion in 2023, making up about 14% of the total federal budget. HHS as a whole has an annual budget of around $1.54 trillion. So if RFK is confirmed, the implications are massive.
Over the last 40 years, corruption in our healthcare system has spun out of control. This is a rare chance to clean up one of the most wasteful and harmful areas of government.
Poor management by HHS has created widespread fraud in Medicare and Medicaid. The FDA’s clinical trials and research have been corrupted by Big Pharma. And Tony Fauci’s NIH disgraced the entire medical field.
Obamacare worsened an already horrid health insurance landscape, and has caused premiums to skyrocket.
Bad behavior has been rewarded time and time again, twisting the entire system’s incentive structures into knots.
We should soon see the first real progress in this area in more than 4 decades.
RFK Jr. and Team
RFK Jr’s MAHA (Make America Healthy Again) movement was a key part of Trump’s victory. I was pleasantly surprised when the two candidates joined forces.
But RFK Jr’s not the only exciting appointment Trump has announced. The NIH will be ripped away from Tony Fauci’s suffocating grip and handed over to Dr. Jay Bhattacharya (pending confirmation).
Bhattacharya is a refreshing choice for NIH. He’s a Stanford professor who spoke out early and often against the COVID lockdowns. He also warned about the rushed deployment of the mRNA vaccines and treatments such as Remdesivir. I’ve followed Jay since early 2020, and as NIH Director he will be a breath of fresh air.
There’s also Marty Makary, Trump’s pick to lead the FDA. He’s a prominent critic of the government’s COVID response, dangerous pesticides, fluoride in drinking water, overuse of antibiotics, and other important issues. Marty understands the value of modern medicine, but also its perils.
What a change from the status quo this team would be! Any Republicans who attempt to prevent their confirmation should be called out loudly and shunned.
Restoring Sanity
President Trump’s second term is poised to revolutionize America’s health care system. Bad actors will finally be punished. Crazy policies like fluoridation of drinking water will (hopefully) be canceled. Dangerous pesticides like Atrazine could be banned or restricted.
Ridiculous policies like the one that requires baby formula to have unhealthy seed oils (soybean, canola) as a primary component should disappear. Harmful food ingredients such as artificial colors may be banned, as they are in many other developed countries.
Highly processed foods will also come under new scrutiny. And it’s likely we’ll see significant changes to the FDA’s food pyramid, which should be inverted or trashed altogether.
Over time, I believe the U.S. will become far healthier under Trump and RFK Jr’s leadership. Even if one or more of Trump’s picks are not confirmed, the public has woken up to the state of our healthcare system and there’s no going back. Change is coming, and Americans are finally ready to embrace it.
Biotech Renaissance?
In an interesting twist of fate, these upcoming changes don’t mean sectors like biotech should be written off. This shift should actually be a positive for small disruptive companies.
For too long the largest pharma companies have maintained an iron grip over the FDA and other regulators. It’s been a 40+ year stretch favoring insiders and power brokers.
Soon we should have a relatively fair and level playing field for the first time in decades. The rampant favoritism and nepotism that has controlled the healthcare field for far too long is finally ending.
Clinicians need to be aware of the 3 classic presentations of myocarditis: chest pain, heart failure (HF)/shock, and/or symptoms related to arrhythmia (eg, presyncope or syncope). In a young person, the history of an antecedent viral infection, or other risk factors that define stage A at-risk for myocarditis, followed by any of these cardiovascular symptoms should raise the suspicion of this diagnosis.
2.
High-sensitivity cardiac troponin (hs-cTn) is a common diagnostic test in patients with suspected myocarditis; however, some patients with myocarditis will not have an elevated hs-cTn. Further research is needed to determine whether a normal level below the limits of detection of current fifth-generation assays can serve as an effective rule-out strategy for this diagnosis, and the prognostic utility of serial measurements.
3.
Cardiac magnetic resonance (CMR) imaging and endomyocardial biopsy (EMB) are considered pivotal tests in the diagnosis of myocarditis. The former often allows the noninvasive diagnosis of stage B or symptomatic myocarditis. When CMR is performed, the diagnosis of myocarditis is based on detection of abnormalities in both T1 and T2 imaging; however, in patients with certain presentations—typically those with reduced ventricular function, deranged hemodynamics/symptomatic HF, or electrical instability—an EMB is warranted to diagnose specific conditions that require etiology-directed therapies, including immunosuppressive agents.
4.
A novel 4-stage classification of myocarditis is proposed. Stage A refers to those having or exposed to risk factors; stage B to those asymptomatic but with evidence of myocardial inflammation; stage C to those with symptomatic myocarditis; and stage D to those with advanced myocarditis (hemodynamic or electrical instability requiring intervention).
5.
Research is needed to define the trajectories of the 4 stages of myocarditis, including their risk of progression to chronic HF. Other key unanswered questions include the rate of progression from stage A to higher stages; how commonly stage B myocarditis occurs either during the development or resolution of myocarditis; what explains the variable rates of progression and improvement among patients; and when does stage D become irreversible?
6.
Risk stratification in patients with symptomatic myocarditis guides the decision whether to refer to an advanced HF center with a multidisciplinary myocarditis team. There should be a low threshold to transfer patients with high-risk features, such as severely reduced ventricular function, symptomatic HF, hemodynamic instability, or electrical instability (either ventricular arrhythmias or heart block).
7.
The follow-up of patients with myocarditis does not end after 2 to 3 weeks, even with resolution of symptoms. Two cardiac imaging studies are advised during follow-up. At an early interval after diagnosis (eg, 2-4 weeks), a repeat echocardiogram allows detection of new or progressive deterioration of left ventricular function suggestive of a diagnosis of giant cell myocarditis (GCM). A second follow-up imaging study, either a repeat echocardiogram (low-risk stage C myocarditis) or a CMR (if > low-risk stage C myocarditis or if stage D myocarditis), is advised at 6 months. Advocacy for insurance coverage of these tests is needed.
8.
Given the increasing recognition of genetic predisposition to myocarditis, genetic counseling and testing is advised for all consenting patients. Discovery of a pathogenic variant should be followed by cascade screening of family members, thereby affording undiagnosed relatives the opportunity for clinical surveillance and, when appropriate, guideline-directed management and therapy.
9.
Safety for return to strenuous physical activity is guided by a follow-up CMR, 24-hour monitoring for arrhythmia, and exercise testing, typically at 6 months after diagnosis. In some athletes, these assessments can be made as early as 3 months after the initial episode of myocarditis for consideration of return to competitive sports.
10.
Further research on a wide range of factors is needed. These include how social determinants of health impact the development and progression of myocarditis; a need for international registries with diverse stakeholder involvement; improved phenotyping by novel biomarkers, imaging strategies, and refined pathological interpretation of EMB specimens, including the role of viral polymerase chain reaction (PCR) testing; the benefits of immunosuppression in lymphocytic myocarditis assessed in large prospective randomized clinical trials; whether unloading of the left ventricle for those on extracorporeal membrane oxygenation (ECMO) improves outcomes; and a greater understanding of the psychological burden on patients and caregivers following an episode of myocarditis.
The U.S. Preventive Services Task Force (USPSTF) plans to add self-collected human papillomavirus (HPV) testing to its recommendations forcervical cancer screening
Task Force Chair Wanda Nicholson, MD, MPH, MBA, of the Milken Institute School of Public Health and George Washington University School of Medicine in Washington D.C., said evidence shows that patient self-collection and clinician collection yields similar results.
"There's no difference in accuracy, and in fact, the self-collection can promote higher screening rates among women who are either under-screened or [have] never been screened," Nicholson told MedPage Today.
While self-collection was on the Task Force's radar for many years, it has not previously been part of the USPSTF cervical screening recommendations. In May, the FDA approved swab-based self-collectionopens in a new tab or window for HPV testing in healthcare settings, though ob/gyns told MedPage Today this option does not entirely replaceopens in a new tab or window the utility of Pap smears and the U.S. still lags behind other nations in self-collection outside healthcare facilities.
Nicholson also noted that most women with cervical cancer are either under-screened or had never been screened, and that African American, Hispanic, American Indian, and Alaska Native women -- as well as women living in rural areas -- die from cervical cancer at higher rates. The Task Force hopes that adding self-collection will improve screening among these at-risk populations.
Jessica Kingston, MD, of UC San Diego Health, who was not part of the Task Force, told MedPage Today that self-collection makes screening more inclusive to people wary of the speculum or who have had traumatic experiences.
"Most healthcare professionals think [getting a Pap test] should be just part of someone's routine of staying healthy, but many people find that a big hurdle to come over," Kingston noted. "With self-collection, we're really kind of combining what we know about what causes cervical cancer and making it much more feasible for a wider population."
Much of the rest of the draft recommendation statement aligns with previous recommendations, which were last updated in 2018opens in a new tab or window. There are no planned changes for women ages 21 to 29, who still should be screened for cervical cancer every 3 years with cervical cytology, the draft statement said.
Women ages 30 to 65 should be screened with an HPV test every 5 years, either with clinician or patient-self collection. However, the Task Force also emphasized that getting a Pap test every 3 years, or co-testing with a combined HPV and Pap test every 5 years, are effective alternative screening options for this group. In the updated draft recommendation statement, all these options still received an A grade recommendation.
"What's new and different is that we have identified HPV as being an optimal screening test in the sense that it has the best balance of benefits and harms," Nicholson said, meaning it detected early signs of cervical cancer with fewer unnecessary follow-up tests.
Additionally, some groups still don't need to be screened for cervical cancer. This includes women younger than 21, women who have had a total hysterectomy and don't have a history of cervical cancer or a high-grade precancerous lesion, and women older than 65 who previously had regular screenings with normal results and are not otherwise at high risk for cervical cancer, all of which get a D grade recommendation.
For this review, the task force considered 81 fair- to good-quality studies. Of these, 19 looked at benefits or harms of HPV-based screening strategies, 22 looked at the accuracy of self-collection in HPV tests, 42 reported on uptake of self-collected HPV tests, and one trial assessed diagnostic accuracy and uptake.
The recommendations apply to cisgender women and people assigned female at birth, including transgender men and some nonbinary people. They do not apply to people with increased risk of developing cervical cancer, including women with HIV, those with compromised immune systems, or those with a history of precancerous lesions or cervical cancer. People with these risk factors should receive condition-specific management.
A federal court in North Dakota has blocked Affordable Care Act (ACA) coverage for immigrants that came into the U.S. illegally as children, also known as “Dreamers.”
U.S. District Judge Daniel M. Traynor on Monday granted Kansas, alongside 18 other states, a stay regarding a final rule from the Biden administration allowing some Dreamers access to the ACA marketplace, according to court documents. He also granted Kansas and the other states a preliminary injunction barring the federal government “enforcing the Final Rule against” them.
In May, the Biden administration announced the final rule, from the Centers for Medicare and Medicaid Services (CMS) that would let active recipients of Deferred Action for Childhood Arrivals (DACA) enroll in a qualified or basic health plan under the ACA, as well as forms of financial assistance.
DACA recipients have been considered not “lawfully present” when it comes to health care law due to prior CMS rules, resulting in some recipients to fall out of coverage.
“The authority granted to CMS by the ACA is to ascertain whether an individual meets the requirements for lawful status. It by no means allows the agency to circumvent congressional authority and redefine the term “lawfully present,” Traynor said in his Monday ruling.
“This decision is a big win for the rule of law,” Kobach said. “Congress never intended that illegal aliens should receive Obamacare benefits. Indeed, two laws prohibit them from receiving such benefits. The Biden administration tried to break those laws. But we fought back and defeated the Biden Justice Department.”
In a statement, a CMS spokesperson said the agency “is reviewing the court’s decision; however, the agency does not comment on litigation.”
The Hill has reached out to the Department of Justice for comment.
