Latest news with #JulieSteenhuysen
Yahoo
13 hours ago
- Business
- Yahoo
Blood test-guided treatment with AstraZeneca pill cuts breast cancer progression risk
By Julie Steenhuysen CHICAGO (Reuters) -Treating breast cancer patients with AstraZeneca's experimental pill camizestrant at the first sign of resistance to standard therapies cut the risk of disease progression or death by half, a finding that could be practice changing, experts said on Sunday. The results, presented at the American Society of Clinical Oncology meeting in Chicago, mark the first use of a blood test called a liquid biopsy to indicate the need for a change in treatment in women with a common form of breast cancer, even before tumor growth can be detected on imaging. The early switch approach in women with hormone receptor-positive, HER2-negative breast cancer resulted in a 56% reduction in the risk of disease progression or death, said Dr. Eleonora Teplinsky, an oncologist at Valley-Mount Sinai Comprehensive Cancer Care and an ASCO breast cancer expert. "When patients progress on scans, we're already behind," Teplinsky said at a media briefing. She said an early switch approach, before disease progression, allows doctors "to essentially stay ahead of the curve." Camizestrant is not yet FDA-approved, but Teplinsky said she believes the data will likely result in a new treatment paradigm. The trial involved 3,256 patients with advanced hormone receptor-positive, HER2-negative breast cancer, the most common type in which hormones such as estrogen fuel cancer growth. These cancers lack high levels of HER2, another cancer driver. Women in the trial had at least six months of treatment with aromatase inhibitors that block hormones fueling the cancer, as well as targeted drugs called CDK4/6 inhibitors such as Novartis' Kisqali, Pfizer's Ibrance or Eli Lilly's Verzenio, which block an enzyme that fuels cancer growth. About 40% of patients treated with aromatase inhibitors develop mutations in the estrogen receptor 1 gene called ESR1 mutations, a sign of early drug resistance. Camizestrant and similar drugs called selective estrogen receptor degraders, or SERDS, block estrogen receptor signaling in cancer cells. In the trial, researchers used blood tests to look for ESR1 mutations until 315 patients were identified. They were randomly assigned to either switch to camizestrant plus the CDK4/6 inhibitor or continue with standard treatment plus a placebo. The researchers found that it took 16 months for the disease to progress in women who got camizestrant, compared with 9.2 months in those who continued on standard therapy, a statistically significant difference in a measure known as progression-free survival. No new side effects were reported and few patients from either group dropped out due to side effects. "This is going to be very impactful for our patients," said Dr. Hope Rugo, head of breast medical oncology at City of Hope in Duarte, California. The question, she said, is how do doctors incorporate the testing into clinical practice. THE FUTURE OF CANCER TREATMENT AstraZeneca Chief Executive Pascal Soriot in a press briefing acknowledged that monitoring patients for drug resistance before cancer progresses would require a switch in practice, but said it represents the future of cancer treatment. "It will be complicated in the beginning," he said, "but over time, like everything else, we will manage to simplify it and it will become part of what people do." In a separate trial, adding AstraZeneca's immunotherapy Imfinzi to standard treatment before and after surgery in patients with early-stage stomach and esophageal cancers helped delay cancer progression or recurrence compared to chemotherapy alone. The global study of nearly 950 patients tested Imfinzi, known chemically as durvalumab, in combination with a chemotherapy regimen called FLOT given around the time of initial cancer surgery. The durvalumab plus FLOT combination led to a 29% reduction in disease recurrence, progression or death, referred to as event-free survival, compare with those who received the chemotherapy regimen alone. "We demonstrate that immunotherapy works in early-stage disease, which is great," lead study author Dr. Yelena Janjigian of Memorial Sloan Kettering Cancer Center in New York told reporters at the meeting. "We did not see any new safety signals, so this will change practice for our patients, which is exciting to see." Both studies were also published on Sunday in the New England Journal of Medicine.
Yahoo
19 hours ago
- Business
- Yahoo
Blood test-guided treatment with AstraZeneca pill cut risk of breast cancer progression, study finds
By Julie Steenhuysen CHICAGO (Reuters) -Treating breast cancer patients with AstraZeneca's experimental pill camizestrant at the first sign of resistance to standard treatments cut the risk of disease progression or death by half, a finding that could change the way such cancers are treated, cancer experts said on Sunday. The results, presented at the American Society of Clinical Oncology meeting in Chicago, mark the first use of a blood test called a liquid biopsy to indicate the need for a change in treatment in women with a common form of breast cancer, even before tumor growth can be detected on imaging. The early switch approach in women with hormone receptor-positive, HER2-negative breast cancer resulted in a 56% reduction in the risk of disease progression or death, said Dr. Eleonora Teplinsky, an oncologist at Valley-Mount Sinai Comprehensive Cancer Care and an ASCO breast cancer expert. "When patients progress on scans, we're already behind," Teplinsky said at a media briefing. She said an early switch approach, before disease progression, allows doctors "to essentially stay ahead of the curve." Camizestrant is not yet FDA-approved, but Teplinsky believes the data will likely result in a new treatment paradigm. The trial involved 3,256 patients with advanced hormone receptor-positive, HER2-negative breast cancer, the most common type in which hormones such as estrogen fuel cancer growth. These cancers lack high levels of HER2, another cancer driver. Women in the trial had at least six months of treatment with aromatase inhibitors that block hormones fueling the cancer, as well as targeted drugs called CDK4/6 inhibitors such as Novartis' Kisqali, Pfizer's Ibrance or Lilly's Verzenio, which block an enzyme that fuels cancer growth. About 40% of patients treated with aromatase inhibitors develop mutations in the estrogen receptor 1 gene called ESR1 mutations, a sign of early drug resistance. Camizestrant and similar drugs called Selective Estrogen Receptor Degraders (SERDS) block estrogen receptor signaling in cancer cells. In the trial, researchers used blood tests to look for ESR1 mutations until 315 patients were identified. They were randomly assigned to either switch to camizestrant plus the CDK4/6 inhibitor (157 patients) or continue with standard treatment plus a placebo (158 patients). The researchers found that it took 16 months for the disease to progress in women who got camizestrant, compared with 9.2 months in those who continued on standard therapy, a statistically significant difference in progression-free survival. No new side effects were reported and few patients from either group dropped out due to side effects. "This is going to be very impactful for our patients," said Dr. Hope Rugo, head of breast medical oncology at City of Hope in Duarte, California. The question, she said, is how do doctors incorporate the testing into clinical practice. Separately, adding AstraZeneca's immunotherapy durvalumab to standard treatment before and after surgery in patients with early-stage stomach and esophageal cancers helped extend the time patients had without cancer progression or recurrence compared to chemotherapy alone. The global study of nearly 950 patients tested durvalumab, sold under the brand Imfinzi, in combination with a chemotherapy regimen called FLOT given around the time of initial cancer surgery. Patients in the durvalumab plus FLOT arm experienced a 29% better event-free survival than those who received the chemotherapy regimen. "We demonstrate that immunotherapy works in early-stage disease, which is great," lead study author Dr. Yelena Jarnigan of Memorial Sloan Kettering Cancer Center in New York told reporters at the meeting. "We did not see any new safety signals, so this will change practice for our patients, which is exciting to see." Both studies were published on Sunday in the New England Journal of Medicine.
Yahoo
3 days ago
- Business
- Yahoo
Gilead commits to HIV prevention rollout for low-income countries despite funding uncertainty
By Julie Steenhuysen and Deena Beasley (Reuters) -Gilead Sciences says it still plans to supply its twice-yearly injection for preventing HIV infection in low-income countries if it wins U.S. approval despite funding uncertainty over the Trump Administration's pullback in aid spending. Some AIDS experts, including activists and doctors, say the Gilead drug, lenacapavir, could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million. An FDA approval decision is expected by June 19 for lenacapavir, which proved to be nearly 100% effective at preventing HIV in large trials. If the Food and Drug Administration green lights the drug, and its view is seconded by the WHO, the shots could start to roll out early in 2026 to at least 2 million people in 18 low-income countries based on Gilead's agreement with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, a worldwide partnership targeting HIV, tuberculosis and malaria. Gilead agreed to provide lenacapavir at cost for two-to-three years while six generic drugmakers, which were granted licenses to make the medicine for low-income countries, ramp up production. Experts said a successful launch of a long-acting HIV prevention drug could help stall the epidemic. Until recently, the only pre-exposure prophylaxis (PrEP) options for people at high risk of infection were daily pills, requiring careful adherence to be effective. "You can foresee a day where there are no new HIV diagnoses. It doesn't happen if we only do this in the U.S.," Gilead Chief Commercial Officer Johanna Mercier said. "We need to make sure we have a global approach to this launch." PEPFAR being part of the effort is Gilead's intent and goal, Mercier said. "Unfortunately, if they're not part of that mix, our goal is still to meet that objective of 2 million people getting access." Wall Street has a close eye on lenacapavir, one of the highest-profile drugs to undergo FDA review since President Donald Trump named Robert F. Kennedy Jr. as health secretary and promised to upend the status quo. Most of the drug's profits are expected in the U.S., with annual sales reaching $1 billion by next year, according to analysts' estimates compiled by LSEG. 'INCREDIBLE DISMAY' Whether all of the agreed funding for low-income countries - most of which are in Africa - will come through is unclear. Countries that rely on aid are already reeling from funding cuts by the Trump Administration, including to PEPFAR, and AIDS researchers are bracing for the worst. The United Nations program on HIV/AIDS earlier this month said many HIV prevention programs supported by PEPFAR were stalled, although services for pregnant and breastfeeding women were technically exempt from the cuts. Peter Sands, executive director of the Global Fund, told Reuters the group intends to fund as much of the lenacapavir rollout as possible, but it will need to start slowly. "It's not just the uncertainty over PEPFAR's funding that's an issue, but the uncertainty over our funding," Sands said, adding that the group's first priority is treating people already infected with the deadly virus. Much will depend on the success of the Global Fund's effort to raise $18 billion to fund its work from 2027-2029. The U.S. is its largest donor, committing $6 billion in the previous funding round. It is unclear what the U.S. may provide this round, or whether other big governments will step up. UNAIDS estimates that the permanent discontinuation of HIV prevention and treatment programs supported by PEPFAR would lead to an additional 6.6 million new HIV infections between 2025 and 2029. The U.S. State Department, which oversees PEPFAR, did not respond to a request for comment. Gilead declined to comment on its manufacturing cost for lenacapavir, whose U.S. price is likely to be on par with current preventive medications at around $25,000 per year. ViiV Healthcare's Apretude, an injection given every two months, costs about 124.20 pounds ($168) in low- and middle-income countries. Mitchell Warren, executive director of the AIDS nonprofit AVAC, estimates the eventual annual cost at $100-$120. The lower the price, the more people who could receive it, he said. Warren said PEPFAR could still participate, and others may come forward. The Gates Foundation and the Children's Investment Fund Foundation are "actively involved in all of these conversations," he said, as is the Elton John AIDS Foundation. Linda-Gail Bekker of the University of Cape Town, who led lenacapavir clinical trials in South Africa and Uganda, said she was elated when she first saw the findings. "The huge feeling I have now is one of incredible dismay," said Bekker of uncertainty over the Trump administration's commitment to PEPFAR and HIV prevention in poor nations. "It felt like the stars were aligning, and one of the stars has fallen out of the sky."
Yahoo
14-05-2025
- Health
- Yahoo
Americans worry about Trump's handling of current measles outbreak, Reuters/Ipsos poll finds
By Jason Lange and Julie Steenhuysen WASHINGTON (Reuters) - Americans worry about President Donald Trump's administration's ability to contain an ongoing outbreak of measles, while the vast majority of them believe that vaccines for the disease are safe, according to a new Reuters/Ipsos poll. Just 31% of respondents in the two-day poll, which closed on Tuesday, agreed with a statement that the current administration is handling the measles outbreak responsibly, while 40% disagreed and the rest were unsure or did not answer the question. The U.S. is currently facing its largest single outbreak of measles in 25 years, with the number of cases crossing the 1,000 mark last week. The measles, mumps and rubella vaccine prevents 97% of cases after two doses and high adoption of the MMR vaccine resulted in the disease being declared eliminated in 2000 by the World Health Organization. Nonetheless, vaccination rates among U.S. children have fallen in recent years, which experts attribute to vaccine skepticism and misinformation. The vast majority of Americans still see the MMR vaccine as safe. Some 86% of respondents in the latest Reuters/Ipsos poll said it was safe for children, a marginally higher share than the 84% who said the same in a Reuters/Ipsos poll conducted in May 2020, in the early months of the COVID pandemic. Some 13% of respondents in the latest poll said the vaccine was not safe for kids, up marginally from 10% five years earlier. The latest poll, which surveyed 1,163 U.S. adults nationwide, had a margin of error of 3 percentage points. Infectious disease experts worry that comments from vaccine skeptic Robert F. Kennedy Jr., the U.S. Secretary for Health and Human Services who has offered mixed messages about the severity of the disease and the safety and efficacy of vaccine, may further exacerbate vaccine hesitancy. Dr. Sean O'Leary, chair of the Infectious Diseases Committee of the American Academy of Pediatrics, said he was encouraged by the high level of confidence in the MMR vaccine given the messaging from the Trump administration. "I do feel a bit better knowing that the public is recognizing that a lot of the information they're seeing right now from the administration is not accurate," O'Leary said. Kennedy, who became the nation's top health official in February, says he is not opposed to vaccines, which he says are the best way to prevent measles. The White House did not immediately respond to a request for comment. DUTY TO VACCINATE CHILDREN Some 76% of respondents in the Reuters/Ipsos poll - including majorities of both Republicans and Democrats - agreed with a statement that it was the duty of all parents to vaccinate their children against measles. One in four Republicans, however, disagreed. Vaccination rates have been declining in the U.S. In the 2019-2020 school year, 95.2% of kindergarteners nationwide completed their two-dose MMR vaccine series, above the 95% threshold needed to protect unvaccinated individuals against the highly contagious disease through herd immunity, according to the Centers for Disease Control and Prevention. Measles vaccination rates dropped to 92.7% in 2023-2024, according to the CDC. Within states, pockets of unvaccinated populations have even lower vaccination rates. In Gaines County, Texas, the epicenter of an outbreak that has infected more than 700 people and killed two unvaccinated children, only 82% of kindergarteners are fully vaccinated. The Texas outbreak has spread to Kansas, Oklahoma and New Mexico, where one adult died from the disease. Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said most Americans are comfortable with the MMR vaccine, which is reflected in high vaccination rates. The problem, he said, is that national vaccination numbers can mask pockets of very low vaccination coverage. "You really have to look at these pockets," Adalja said. "That's what makes us very vulnerable." Some 55% of respondents in the Reuters/Ipsos poll said they were concerned about measles outbreaks - on par with the number who worried about being laid off from their jobs and well below the 80% who worried about rising inflation. Just 32% of respondents in the poll said they thought the current administration would stop the current outbreak and prevent measles from becoming a common illness again.
Yahoo
24-04-2025
- Health
- Yahoo
As FDA delays Novavax' COVID vaccine approval, patients fight back
By Julie Steenhuysen CHICAGO (Reuters) -Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might still win approval after Health Secretary Robert F. Kennedy Jr cast doubt on its efficacy. The Novavax vaccine is the only COVID-19 booster in the United States that does not use messenger RNA technology - which some states have begun to ban - and the only option for many people who cannot or will not take an mRNA vaccine. While more traditional vaccines, including the Novavax shot, inject a portion of the virus into the body, mRNA vaccines carry instructions for human cells to make the viral protein that triggers an immune response. Novavax has been available since 2022 through a pandemic-era Emergency Use Authorization. A decision on full approval – which rival mRNA shots from Moderna and Pfizer and its partner BioNTech already have - was due from the Food and Drug Administration by April 1, but had been delayed by the FDA without explanation. On Wednesday, the company got word that the FDA would consider approving the vaccine, provided Novavax agrees to produce additional clinical data on the vaccine's efficacy following its approval. Based on its communication, the company said it now believes its application is "approvable." Asked the reason for delay and the request for more data, an HHS spokesperson said the agency remains committed to "ensuring products are safe for the American people and grounded in gold-standard science." Without FDA approval, patients and vaccine experts say a group of people, including many patients with long COVID, will be left without a means of protecting themselves. "It's reassuring to see an update, but we're not celebrating just yet," said Paul Hennessy, 35, an entertainment project manager from Los Angeles and volunteer with Organizing for a Better Tomorrow, a long COVID advocacy group. Hennessy helped organize more than 3,200 people to submit written comments to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices on April 16. The group has also been calling and emailing officials at the FDA. VACCINE PROMISES Kennedy, a longtime vaccine critic and environmental lawyer who in 2021 petitioned the FDA to revoke the emergency use authorization for all COVID vaccines, attributed the delay to the shot's design in an April 10 CBS interview. He said the Novavax shot targets only one antigen or part of the virus to produce an immune response and "single-antigen vaccines have never worked for respiratory illnesses." The comments baffled vaccine experts, who noted many examples of effective single-antigen vaccines against respiratory illnesses. All of the first-generation COVID-19 vaccines were single-antigen vaccines, "so they clearly worked," said one vaccine researcher who requested anonymity for fear of retribution against his university. Kennedy has repeatedly said he would not take away anyone's vaccine, including during his Senate confirmation hearing and most recently in his CBS interview. But patients are wary. "It feels like the complete opposite of that - that he intends to take this option away from many people who need it," said Kaiti Murphy of Brooklyn, New York. Murphy, 32, has long COVID and mast cell activation syndrome, a condition in which the immune system becomes hyperactive, which her doctor believes was triggered by her COVID infection in 2020. "He has advised me not to take any mRNA vaccines," she said. She, like many people with long COVID, relies on COVID boosters to avoid reinfections with the virus, which can cause their symptoms to flare. "Pulling it off the market would really be a threat to my health," said Salvatore Mattera, a finance manager for a technology company who has long COVID, a collection of debilitating symptoms that persist among some people long after a COVID-19 infection. Mattera, 36, of Foster City, California, has had adverse reactions after taking an mRNA vaccine, including numbness in his face severe enough to send him to the hospital ER. After he switched to Novavax - which he has had three times - he has had no negative side effects beyond a sore arm. As with much about long COVID, evidence on the impact of COVID boosters is scant. In a small, soon-to-be published study by Yale immunobiologist Dr. Akiko Iwasaki and colleagues, the team found that while most people with long COVID fared well with an mRNA booster, 3 out of 16 volunteers had worsening symptoms, including one patient who was hospitalized. The Novavax vaccine was not available during the study period, but Iwasaki said because it has lower reactogenicity, or short-term side effects such as arm pain or fatigue, "I suspect that patients with long COVID may have an easier time with it." In written comments to CDC's advisory panel last week, many people gave fewer side effects as their reason for urging approval. Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said that while he thinks the Novavax booster may eventually win approval, "it appears that they are trying to increase the regulatory burden," something he said is to be expected from a department headed by an anti-vaccine advocate such as RFK Jr. Meanwhile, as the current batch of Novavax boosters expires on April 30, many on the social media platform Reddit are swapping information on where to find the scarce last doses ahead of what has become a routine summer wave of COVID. "It's a step in the right direction," Hennessy said of the FDA action, "but we still need access."
