Latest news with #Johnson&Johnson
Yahoo
18 hours ago
- Business
- Yahoo
Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer
Pasritamig, a first-in-class bispecific T-cell-engaging antibody, shows potential in mCRPC with outpatient dosing designed for the community setting Data show low rates of treatment-related adverse events, signaling human kallikrein 2 (KLK2) as a novel, highly specific target CHICAGO, June 1, 2025 /PRNewswire/ -- Johnson & Johnson announced today new data from a Phase 1 study evaluating pasritamig (JNJ-78278343), a first-in-class bispecific antibody that activates T-cells to harness the body's immune system against prostate cancer cells, showing promise in patients with advanced disease who have progressed after multiple lines of therapy. These first data on pasritamig, from the first-in-human study, demonstrate that pasritamig appears well-tolerated and exhibits a promising antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC), highlighting the potential of KLK2 as a novel target for T-cell engagement in advanced disease.1 These data were presented as an oral presentation (Abstract #5017) at the 2025 American Society of Clinical Oncology Annual Meeting and published simultaneously in The Journal of Clinical Oncology. Pasritamig is a novel T-cell engager designed to bind both CD3 on T-cells and KLK2—a prostate-specific antigen with minimal expression outside of the prostate. Pasritamig activates T-cells by binding to CD3 and directing them to KLK2- expressing tumor cells, engaging the body's immune system to specifically target these cancerous cells. This differentiated approach aims to deliver a targeted treatment for patients with advanced prostate cancer, while potentially reducing the high-grade toxicities historically associated with T-cell engagers. "These first-in-human results for pasritamig are highly encouraging, demonstrating that KLK2 is a viable target for T-cell engagers in metastatic castration-resistant prostate cancer," said Capucine Baldini*, M.D., Ph.D., Drug Development Department (DITEP), Institut Gustave Roussy, and presenting author. "The data show a promising safety profile, with manageable adverse events and no AEs leading to treatment discontinuations or ICANS observed, with 40 percent of patients having no treatment-related AEs at all. Given the limited treatment options for mCRPC, these findings support further investigation of pasritamig and the role of KLK2-targeted T-cell therapies as a potential new approach for patients with aggressive disease." "Metastatic castration-resistant prostate cancer remains one of the most difficult stages of prostate cancer to treat, particularly for patients who haven't responded well to previous treatments," said Jeff Infante, M.D., Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine. "This investigational approach underscores our commitment to developing innovative and practice-changing medicines that are well-tolerated and can be easily administered in community practice settings." The Phase 1 first-in-human study (NCT04898634) evaluated 174 patients with ages ranging from 36 to 89 years old and on average having received four prior therapies (range 1-13). The recommended phase 2 dose (RP2D) of pasritamig was 3.5mg on day 1, 18mg on day 8, 300mg intravenously on day 15 and then once every six weeks. The RP2D safety group also included patients treated once every three weeks as the toxicity profiles were very similar. The RP2D efficacy group only included patients treated at the RP2D once every six weeks.1 Within the RP2D safety group (n=45), treated once every three or six weeks, 100 percent had previously received androgen receptor pathway inhibitors, 75.6 percent had undergone taxane chemotherapy, and 37.8 percent had been treated with Lutetium 177 vipivotide tetraxetan prostate-specific membrane antigen radioligand therapy.1 The most common treatment- related adverse events (TRAEs) were Grade 1/2 infusion-related reactions (24.4 percent), Grade 1 cytokine release syndrome (CRS) presenting as fever only (8.9 percent, no steroid or tocilizumab was administered) and no reports of higher grade CRS. No TRAEs leading to treatment discontinuation or dose reduction were reported and no immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. Grade 3 TRAEs were infrequent with 4.4 percent of patients reporting transient AST/ALT increases and neutropenia. There were no dose-limiting toxicities reported. The favorable safety profile of the RP2D regimen enabled convenient outpatient administration on a patient-friendly, once-every-six-weeks schedule.1 Of the patients in the RP2D efficacy group (n=33), treated once every six weeks, 42.4 percent achieved a 50 percent or greater reduction in their prostate-specific antigen (PSA) levels with a median rPFS of 7.9 months (95 percent confidence interval [CI] 2.9, not estimable [NE]) and 21.2 percent of patients continuing therapy. Treatment with pasritamig showed durable disease control and rPFS that compares favorably to historical data in heavily pretreated patients with mCRPC.1 Metastatic castration-resistant prostate cancer occurs in a significant portion of prostate cancer patients, with many progressing despite initial therapies.2 Overall survival from diagnosis of mCRPC patients ranges from 13.5 to 31.6 months, and lower in patients who have progressed on therapy.3 Treatment options remain limited, underscoring the urgent need for safer and more effective therapies.4 About Pasritamig (JNJ-78278343)Pasritamig (JNJ-78278343) is an investigational T-cell-engaging bispecific antibody (bsAb) targeting human kallikrein 2 (KLK2) on prostate cancer cells and CD3 on T-cells. This approach is being evaluated in heavily pretreated patients with metastatic castration-resistant prostate cancer (mCRPC), a patient population with limited treatment options. About Metastatic Castration-Resistant Prostate Cancer (mCRPC)Metastatic castration-resistant prostate cancer (mCRPC) is a challenging and aggressive stage of prostate cancer where the disease progresses despite androgen deprivation therapy.2 Patients often experience metastasis to bones and lymph nodes, leading to poor outcomes and limited treatment options, including chemotherapy and second-line hormone therapies.5 The median overall survival ranges from 13.5 to 31.6 months depending on the site of metastasis, with a typical range of 15–36 months across the broader population.3,6 Survival rates can vary significantly depending on factors such as prior treatment history, disease burden, and response to therapy. The need for more effective treatments is critical, as the disease continues to impact a large number of men globally, with mCRPC being responsible for a substantial number of prostate cancer-related deaths. About Johnson & JohnsonAt 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 or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen Global Services, LLC and Janssen Scientific Affairs, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking StatementsThis 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 JNJ-78278343. 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 materialize, 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; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior 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. Source: Johnson & Johnson *Dr. Capucine Baldini has provided consulting, advisory, and speaking services to Johnson & Johnson; Dr. Baldini has not been paid for any media work. 1 Baldini, C., et al. Phase 1 Study Results of Pasritamig (JNJ-78278343) in Metastatic Castration-Resistant Prostate Cancer. 2025 American Society of Clinical Oncology Annual Meeting. June 2025.2 Scher, H. I., et al. (2016). "Treatment of castration-resistant prostate cancer: Current and future strategies." Nature Reviews Clinical Oncology, 13(10), 577-590.3 Wallace KL, Landsteiner A, Bunner SH, Engel-Nitz NM, Luckenbaugh AN. Increasing prevalence of metastatic castration-resistant prostate cancer in a managed care population in the United States. Cancer Causes Control. 2021;32(12):1365-1374. doi:10.1007/s10552-021-01484-44 Ravi P, Mateo J, Lorente D, et al. Clinical prognostic factors and management of metastatic castration-resistant prostate cancer: a population-based study. PLoS One. 2015;10(10):e0139440. doi:10.1371/ Ryan, C. J., et al. (2015). "Abiraterone acetate in metastatic prostate cancer: A new era." Journal of Clinical Oncology, 33(10), 1051-1060.6 Kawahara, T., Saigusa, Y., Yoneyama, S. et al. Development and validation of a survival nomogram and calculator for male patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate and/or enzalutamide. BMC Cancer 23, 214 (2023). Media contacts:Oncology Media Relations oncology_media_relations@ Investor contact:Lauren Johnsoninvestor-relations@ U.S. Medical Inquiries +1 800 526-7736 View original content to download multimedia: SOURCE Johnson & Johnson Sign in to access your portfolio
Yahoo
3 days ago
- Business
- Yahoo
When the Status Quo Doesn't Cut It
This is an edition of the Books Briefing, our editors' weekly guide to the best in books. Sign up for it here. Why are so many Americans so eager to find alternatives—political, medical, vocational—to the status quo? By many measures, the 9-to-5 workplace, the medical industry, and other mainstays of American life seem to have served the country's population very well: The United States has the world's largest economy, and its population is far healthier and wealthier than it was before World War II. Yet in 2023, North Americans spent an average of $5,800 each on 'wellness' treatments whose efficacy has not always been backed by research. One in 13 Americans have participated in multilevel marketing, even though research has shown that 99 percent of them lose money in the process, and 30 percent supported a Cabinet position for Robert F. Kennedy Jr., the leader of the movement to 'make America healthy again,' who has falsely claimed that vaccines cause autism. This state of affairs has animated several stories in The Atlantic's books section over the past two weeks, and all of them identify the same basic answer: The status quo is no longer working. First, here are four new stories from The Atlantic's books desk: A reality check for tech oligarchs The world that Wages for Housework wanted Five books that will redirect your attention 'I Remember': A poem by William H. McRaven As Adam M. Lowenstein wrote in his essay on Gardiner Harris's No More Tears, an exposé about the pharmaceutical giant Johnson & Johnson's persistent efforts to downplay the risks of some of its products, evidence that the health-care system puts profits first may have 'left some people so disillusioned and distrustful that they were willing to try anything else.' Cases of pharmaceutical wrongdoing give a message like Kennedy's—that the medical industry is corrupt—an understandable appeal. This same message underlies the $6.3 trillion wellness industry, with its array of purported miracle cures. Sheila McClear, in an essay on Amy Larocca's new book, How to Be Well, wrote this week that 'Americans are exhausted from navigating a health-care system so costly and inconvenient that it has sent many of them scrambling for alternatives.' Those who can't find a therapist who takes insurance can instead buy a '$38 jar of adaptogenic 'dust' that claims to improve your mood,' for example, while the wealthy can enroll in boutique health services that make house calls. This deep distrust in American institutions—and the parade of disruptive entrepreneurs eager to take advantage of it—extends far beyond the medical arena. Last week, Lora Kelley wrote about Bridget Read's book Little Bosses Everywhere, a history of MLMs—companies that hire salespeople who earn commissions by signing up more salespeople. These businesses first proliferated during the Great Depression, and it felt like no coincidence to Kelley that they resurged online a few years ago during the 'Great Resignation,' when growing numbers of workers were laid off or quit out of frustration. Many modern MLMs, Kelley writes, 'promise what American jobs used to: security, freedom, dignity. Those promises have consistently failed to materialize. But the fact that so many are desperate to get in on the schemes each year is not a credit to the broader job market.' She summarizes Read's argument like so: 'MLMs are a toxin masquerading as a cure.' McClear, in her article, writes that the second Trump administration has opened the gates to medical skeptics. Casey Means, a wellness influencer, is the current nominee for surgeon general, and Kennedy now leads the Department of Health and Human Services. McClear notes that some of Kennedy's policy positions, such as curbs on microplastics, unhealthy foods, and unscrupulous pharmaceutical companies, could be productive reforms, and others, such as reducing access to vaccines and fluoride, feel like dubious solutions in search of a problem. It's not so hard to argue that the current state of the nation has left many people disappointed—in some cases, desperate for something that works. But this doesn't mean that any alternative is necessarily better. Some are proving to be demonstrably worse. The Perilous Spread of the Wellness Craze By Sheila McClear A new book reveals how health-care inequality fueled the spread of anti-science conspiracy theories. Read the full article. , by Denis Johnson Johnson's drama of the American frontier is barely a novel; the thin paperback can be started on a hot afternoon and finished by happy hour. Yet it has accrued a devoted following in the nearly 15 years since it was published, because it conjures a great expanse—the mythic West. Its main character, Robert Grainier, works as a contract laborer for the railroads running through Idaho and Washington State. Sweating and straining, he hauls down giant conifers in the region's old-growth forests. He feels a sweet freedom while riding over freshly laid rail, watching the wilderness blur by through a boxcar's slats. Train Dreams is not overly romantic about its time and place: In the first chapter, Grainier's boss orders him to throw a Chinese laborer off an unfinished bridge. A curse later seems to fall upon Grainier. He experiences God's cosmic vengeance, a cleansing fire racing across the dry landscape. Johnson has a cinematic style, lingering on images. But the novella barrels forward with the locomotion evoked in its title, until the end of Grainier's days, and the end of the Old West. Give it a few hours in June, and it may hold on to your imagination until August. — Ross Andersen From our list: The 2025 summer reading guide 📚 Atmosphere, by Taylor Jenkins Reid 📚 Baddest Man: The Making of Mike Tyson, by Mark Kriegel 📚 Charlottesville: An American Story, by Deborah Baker The Talented Mr. Vance By George Packer J. D. Vance poses a problem, and at its core is a question about character. In the years after the 2016 election, he transformed himself from a center-right memoirist and public speaker, offering a complex analysis of America's social ills and a sharp critique of Donald Trump, into a right-wing populist politician whose illiberal ideas and vitriolic rhetoric frequently out-Trump the original. According to Vance and his supporters, this change followed a realization during Trump's first term that the president was lifting up the fallen working class of the heartland that had produced young J. D. To help his people, Vance had to make his peace with their champion. According to his critics, Vance cynically chose to betray his true values in order to take the only path open to an ambitious Republican in the Trump era, and as a convert under suspicion, he pursued it with a vengeance. In one account, a poor boy from the provinces makes good in the metropole, turns against his glittering benefactors, and goes home to fight for his people. In the other, the poor boy seizes every opportunity on his way up, loses his moral compass, and is ruined by his own ambition. Read the full article. When you buy a book using a link in this newsletter, we receive a commission. Thank you for supporting The Atlantic. Sign up for The Wonder Reader, a Saturday newsletter in which our editors recommend stories to spark your curiosity and fill you with delight. Explore all of our newsletters. Article originally published at The Atlantic
Atlantic
3 days ago
- Health
- Atlantic
When the Status Quo Doesn't Cut It
This is an edition of the Books Briefing, our editors' weekly guide to the best in books. Sign up for it here. Why are so many Americans so eager to find alternatives—political, medical, vocational—to the status quo? By many measures, the 9-to-5 workplace, the medical industry, and other mainstays of American life seem to have served the country's population very well: The United States has the world's largest economy, and its population is far healthier and wealthier than it was before World War II. Yet in 2023, North Americans spent an average of $5,800 each on 'wellness' treatments whose efficacy has not always been backed by research. One in 13 Americans have participated in multilevel marketing, even though research has shown that 99 percent of them lose money in the process, and 30 percent supported a Cabinet position for Robert F. Kennedy Jr., the leader of the movement to 'make America healthy again,' who has falsely claimed that vaccines cause autism. This state of affairs has animated several stories in The Atlantic 's books section over the past two weeks, and all of them identify the same basic answer: The status quo is no longer working. First, here are four new stories from The Atlantic 's books desk: As Adam M. Lowenstein wrote in his essay on Gardiner Harris's No More Tears, an exposé about the pharmaceutical giant Johnson & Johnson's persistent efforts to downplay the risks of some of its products, evidence that the health-care system puts profits first may have 'left some people so disillusioned and distrustful that they were willing to try anything else.' Cases of pharmaceutical wrongdoing give a message like Kennedy's—that the medical industry is corrupt—an understandable appeal. This same message underlies the $6.3 trillion wellness industry, with its array of purported miracle cures. Sheila McClear, in an essay on Amy Larocca's new book, How to Be Well, wrote this week that 'Americans are exhausted from navigating a health-care system so costly and inconvenient that it has sent many of them scrambling for alternatives.' Those who can't find a therapist who takes insurance can instead buy a '$38 jar of adaptogenic 'dust' that claims to improve your mood,' for example, while the wealthy can enroll in boutique health services that make house calls. This deep distrust in American institutions—and the parade of disruptive entrepreneurs eager to take advantage of it—extends far beyond the medical arena. Last week, Lora Kelley wrote about Bridget Read's book Little Bosses Everywhere, a history of MLMs—companies that hire salespeople who earn commissions by signing up more salespeople. These businesses first proliferated during the Great Depression, and it felt like no coincidence to Kelley that they resurged online a few years ago during the ' Great R esignation,' when growing numbers of workers were laid off or quit out of frustration. Many modern MLMs, Kelley writes, 'promise what American jobs used to: security, freedom, dignity. Those promises have consistently failed to materialize. But the fact that so many are desperate to get in on the schemes each year is not a credit to the broader job market.' She summarizes Read's argument like so: 'MLMs are a toxin masquerading as a cure.' McClear, in her article, writes that the second Trump administration has opened the gates to medical skeptics. Casey Means, a wellness influencer, is the current nominee for surgeon general, and Kennedy now leads the Department of Health and Human Services. McClear notes that some of Kennedy's policy positions, such as curbs on microplastics, unhealthy foods, and unscrupulous pharmaceutical companies, could be productive reforms, and others, such as reducing access to vaccines and fluoride, feel like dubious solutions in search of a problem. It's not so hard to argue that the current state of the nation has left many people disappointed—in some cases, desperate for something that works. But this doesn't mean that any alternative is necessarily better. Some are proving to be demonstrably worse. The Perilous Spread of the Wellness Craze By Sheila McClear A new book reveals how health-care inequality fueled the spread of anti-science conspiracy theories. What to Read Train Dreams, by Denis Johnson Johnson's drama of the American frontier is barely a novel; the thin paperback can be started on a hot afternoon and finished by happy hour. Yet it has accrued a devoted following in the nearly 15 years since it was published, because it conjures a great expanse—the mythic West. Its main character, Robert Grainier, works as a contract laborer for the railroads running through Idaho and Washington State. Sweating and straining, he hauls down giant conifers in the region's old-growth forests. He feels a sweet freedom while riding over freshly laid rail, watching the wilderness blur by through a boxcar's slats. Train Dreams is not overly romantic about its time and place: In the first chapter, Grainier's boss orders him to throw a Chinese laborer off an unfinished bridge. A curse later seems to fall upon Grainier. He experiences God's cosmic vengeance, a cleansing fire racing across the dry landscape. Johnson has a cinematic style, lingering on images. But the novella barrels forward with the locomotion evoked in its title, until the end of Grainier's days, and the end of the Old West. Give it a few hours in June, and it may hold on to your imagination until August. — Ross Andersen 📚 Baddest Man: The Making of Mike Tyson, by Mark Kriegel 📚 Charlottesville: An American Story, by Deborah Baker Your Weekend Read The Talented Mr. Vance By George Packer J. D. Vance poses a problem, and at its core is a question about character. In the years after the 2016 election, he transformed himself from a center-right memoirist and public speaker, offering a complex analysis of America's social ills and a sharp critique of Donald Trump, into a right-wing populist politician whose illiberal ideas and vitriolic rhetoric frequently out-Trump the original. According to Vance and his supporters, this change followed a realization during Trump's first term that the president was lifting up the fallen working class of the heartland that had produced young J. D. To help his people, Vance had to make his peace with their champion. According to his critics, Vance cynically chose to betray his true values in order to take the only path open to an ambitious Republican in the Trump era, and as a convert under suspicion, he pursued it with a vengeance. In one account, a poor boy from the provinces makes good in the metropole, turns against his glittering benefactors, and goes home to fight for his people. In the other, the poor boy seizes every opportunity on his way up, loses his moral compass, and is ruined by his own ambition.
CNBC
3 days ago
- Business
- CNBC
Watch CNBC's full interview with Johnson & Johnson chairman and CEO Joaquin Duato
CNBC's Angelica Peebles and Johnson & Johnson chairman and CEO Joaquin Duato join 'Squawk Box' to discuss the company's 5-year multiple myeloma treatment study, the company's cancer treatments, M&A outlook, 'most favored nation' pricing, and more.
CNBC
3 days ago
- Business
- CNBC
J&J CEO Joaquin Duato on cancer treatments, M&A outlook and 'most favored nation' policy
CNBC's Angelica Peebles and Johnson & Johnson chairman and CEO Joaquin Duato join 'Squawk Box' to discuss the company's 5-year multiple myeloma treatment study, the company's cancer treatments, M&A outlook, 'most favored nation' pricing, and more.
