Latest news with #clinicaltrials
The Independent
8 hours ago
- Business
- The Independent
‘Breakthrough' breast cancer treatment can help women live longer
A 'breakthrough' new three-drug combination offers hope for women battling an aggressive form of breast cancer, potentially extending their lives and delaying the need for chemotherapy, according to new research. Experts suggest the treatment could become the "new go-to option" for individuals with PIK3CA-mutated hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer, a condition where a mutation in the PIK3CA gene leads to uncontrolled cell division. The findings come from the INAVO120 study, led by researchers at The Institute of Cancer Research, London, and the Royal Marsden NHS Foundation Trust. The results, which included 325 patients from 28 countries, were published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. More than half had metastatic breast cancer that had spread to three or more organs and the majority had already had chemotherapy. Researchers used a blood test known as a liquid biopsy, which detects tumour DNA in the blood, to test for the PIK3CA mutation. Of the total, 161 were given a three-drug combination comprising two targeted drugs – palbociclib, a type of cancer growth blocker, and a new drug called inavolisib, which blocks the activity of the PI3K protein – as well as the hormone therapy fulvestrant. The placebo group, which included 164 patients, was given a dummy pill plus palbociclib and fulvestrant. The study found the median overall survival in the inavolisib group was 34 months, compared with 27 months in the placebo group. The three-drug therapy also delayed disease progression by 17.2 months, compared with 7.3 months in the placebo group, with patients also able to delay chemotherapy treatment by almost two years longer. The latest results come after previous analysis of the study, published in October, showed the three-drug therapy delayed disease progression by an average of 15 months compared with 7.3 months in the placebo group. Lead author Nick Turner, a professor of molecular oncology at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said: 'The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. 'It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible. 'These results give us confidence that this treatment could become the new go-to option for patients who have HR+, HER2- breast cancer with a PIK3CA mutation, as it has shown significant improvements in both survival and quality of life.' It is estimated that about 55,000 women are diagnosed with breast cancer in the UK every year, some 70% of whom will have HR+, HER2- breast cancer. PIK3CA mutations are found in 35-40% of HR+ breast cancers. The three-drug therapy of inavolisib, palbociclib and fulvestrant is not approved in the UK. However, the combination of palbociclib and fulvestrant has been available as an option for patients with certain types of breast cancer on the NHS since 2022. Prof Kristian Helin, chief executive of The Institute of Cancer Research, London, added: 'If we are to continue improving cancer survival rates, we need to tackle treatment resistance head on. 'This research demonstrates how this triple combination approach effectively shuts down cancer's escape routes, giving people with metastatic breast cancer the opportunity to live well for longer. 'One of the challenges with combination therapies is ensuring the right drug dosages and understanding their individual effects. 'It is extremely encouraging that this study not only demonstrates the effectiveness of this approach but also shows that the therapy was generally well tolerated by patients.' Reacting to the findings, Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, said: 'This is a significant breakthrough and we're proud that it builds on a series of discoveries that our funded scientists have been making at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research, London, since it opened 25 years ago. 'We now hope to see this new combination therapy can be licensed by the MHRA (Medicines and Healthcare Products Regulatory Agency) and assessed by Nice (the National Institute for Health and Care Excellence) and the Scottish Medicine Council as soon as possible so that it can reach the NHS patients who could benefit from it.'
Yahoo
8 hours ago
- Business
- Yahoo
Tempus AI announces 10 abstracts accepted for presentation at 2025 ASCO meeting
Tempus AI (TEM) announced that ten abstracts have been accepted for presentation at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting. The event will take place May 30 – June 3 in Chicago, Illinois. Tempus will present its cutting-edge clinical findings and innovative technologies, highlighting the company's use of AI-driven solutions to advance precision oncology. 'At ASCO 2025, we are proud to showcase a diverse portfolio of studies that highlight how our cutting-edge technologies, including tumor-naive and tumor-informed MRD monitoring, whole genomic sequencing for hematologic malignancies, and multi-omic biomarker profiling, are providing clinicians and researchers with actionable insights to personalize treatment and improve outcomes for patients,' said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. 'We are excited to share these advancements and collaborate with the oncology community to shape the future of precision medicine.' Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on TEM: Disclaimer & DisclosureReport an Issue Tempus AI Stock (TEM) Could See 'Tesla or Nvidia-Type Inflection,' Claims Short Seller Cathie Wood's ARK Investment bought 251K shares of Tempus AI today AI Daily: Nvidia suppliers accelerate production of Blackwell AI server racks Tempus AI down 3% after Spruce Point short report Spruce Point short Tempus AI, sees 50%-60% potential downside risk Erreur lors de la récupération des données Connectez-vous pour accéder à votre portefeuille Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données Erreur lors de la récupération des données
Reuters
9 hours ago
- Business
- Reuters
Pfizer-Arvinas breast cancer drug tops AstraZeneca's in delaying progression
May 31 (Reuters) - An experimental treatment by Pfizer (PFE.N), opens new tab and Arvinas (ARVN.O), opens new tab delayed progression of breast cancer by more than three months compared to AstraZeneca's (AZN.L), opens new tab Faslodex in patients with a specific gene mutation, according to trial results announced on Saturday. The findings were presented in Chicago at the annual meeting of the American Society of Clinical Oncology and published in The New England Journal of Medicine. The trial found the experimental drug vepdegestrant increased survival without progression of the disease in patients with ESR1 mutations by five months, compared to about two months for Faslodex. The findings followed initial results of the study in March. Those showed the benefit of vepdegestrant in patients with the mutations but failed to show benefit in a larger set of patients, sending Arvinas' shares to a record low. Saturday's more detailed data showed vepdegestrant increased survival in the larger group of patients by 3.8 months, versus 3.6 months for Faslodex. The late-stage study enrolled 624 previously treated patients with a type of breast cancer that accounts for nearly 70% of all such cancers. Erica Hamilton, one of the authors of the study, said that Faslodex "clearly has some challenges now," adding that it is injected into a muscle, versus vepdegestrant's more convenient oral dosing. Vepdegestrant belongs to a novel class of drugs called PROTAC ER degraders, which are designed to harness the body's natural protein disposal system to specifically target and degrade proteins that spur tumor growth. Breast cancer accounts for about one-third of all new female cancers each year in the U.S., according to the American Cancer Society. Approved treatments for this type of advanced breast cancer include Eli Lilly's (LLY.N), opens new tab Verzenio, Pfizer's Ibrance and Novartis' (NOVN.S), opens new tab Kisqali. Leerink Partners analyst Andrew Berens expects vepdegestrant to earn $576 million in peak sales in 2032. Earlier this month, Arvinas said that it will not move forward with two other planned late-stage studies of the drug.
Yahoo
9 hours ago
- Business
- Yahoo
Three-drug therapy helps women with aggressive breast cancer live longer
A new three-drug combination could help women with a common form of aggressive breast cancer live longer, research suggests. The treatment could also delay the need for gruelling chemotherapy, according to a trial. Researchers are hopeful the combination could become the 'new go-to option' for women with PIK3CA-mutated hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer. This mutation in the PIK3CA gene causes cells to divide and replicate uncontrollably. The final results from the INAVO120 study, led by experts at The Institute of Cancer Research, London, and the Royal Marsden NHS Foundation Trust, have been published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. The trial included 325 patients from across 28 countries. More than half had metastatic breast cancer that had spread to three or more organs and the majority had already had chemotherapy. Researchers used a blood test known as a liquid biopsy, which detects tumour DNA in the blood, to test for the PIK3CA mutation. Of the total, 161 were given a three-drug combination comprising two targeted drugs – palbociclib, a type of cancer growth blocker, and a new drug called inavolisib, which blocks the activity of the PI3K protein – as well as the hormone therapy fulvestrant. The placebo group, which included 164 patients, was given a dummy pill plus palbociclib and fulvestrant. The study found the median overall survival in the inavolisib group was 34 months, compared with 27 months in the placebo group. The three-drug therapy also delayed disease progression by 17.2 months, compared with 7.3 months in the placebo group, with patients also able to delay chemotherapy treatment by almost two years longer. The latest results come after previous analysis of the study, published in October, showed the three-drug therapy delayed disease progression by an average of 15 months compared with 7.3 months in the placebo group. Lead author Nick Turner, a professor of molecular oncology at The Institute of Cancer Research, London, and consultant medical oncologist at The Royal Marsden NHS Foundation Trust, said: 'The key findings from this study showed that the inavolisib-based therapy not only helped patients live longer but it more than doubled the time before their cancer progressed or worsened. 'It also gave them more time before needing subsequent chemotherapy which we know is something that patients really fear and want to delay for as long as possible. 'These results give us confidence that this treatment could become the new go-to option for patients who have HR+, HER2- breast cancer with a PIK3CA mutation, as it has shown significant improvements in both survival and quality of life.' It is estimated that about 55,000 women are diagnosed with breast cancer in the UK every year, some 70% of whom will have HR+, HER2- breast cancer. PIK3CA mutations are found in 35-40% of HR+ breast cancers. The three-drug therapy of inavolisib, palbociclib and fulvestrant is not approved in the UK. However, the combination of palbociclib and fulvestrant has been available as an option for patients with certain types of breast cancer on the NHS since 2022. Prof Kristian Helin, chief executive of The Institute of Cancer Research, London, added: 'If we are to continue improving cancer survival rates, we need to tackle treatment resistance head on. 'This research demonstrates how this triple combination approach effectively shuts down cancer's escape routes, giving people with metastatic breast cancer the opportunity to live well for longer. 'One of the challenges with combination therapies is ensuring the right drug dosages and understanding their individual effects. 'It is extremely encouraging that this study not only demonstrates the effectiveness of this approach but also shows that the therapy was generally well tolerated by patients.' Reacting to the findings, Dr Simon Vincent, director of research, support and influencing at Breast Cancer Now, said: 'This is a significant breakthrough and we're proud that it builds on a series of discoveries that our funded scientists have been making at the Breast Cancer Now Toby Robins Research Centre at The Institute of Cancer Research, London, since it opened 25 years ago. 'We now hope to see this new combination therapy can be licensed by the MHRA (Medicines and Healthcare Products Regulatory Agency) and assessed by Nice (the National Institute for Health and Care Excellence) and the Scottish Medicine Council as soon as possible so that it can reach the NHS patients who could benefit from it.'
Yahoo
12 hours ago
- Business
- Yahoo
Fulcrum Therapeutics, Inc. (FULC): A Bull Case Theory
We came across a bullish thesis on Fulcrum Therapeutics, Inc. (FULC) on Stock Pursuit's Substack. In this article, we will summarize the bulls' thesis on FULC. Fulcrum Therapeutics, Inc. (FULC)'s share was trading at $6.44 as of 23rd May. FULC's trailing P/E was 312.50 according to Yahoo Finance. A scientist in a lab conducting research on cell-based therapeutics and biotechnology. Fulcrum Therapeutics (FULC) recently surged over 110% from around $3.30 to $7.00, reflecting growing optimism but also presenting a prime opportunity to take profits. The company's lead candidate, Pociredir (FTX-6058), is an oral small molecule in Phase 1b trials aimed at treating Sickle Cell Disease (SCD) by increasing fetal hemoglobin expression. While early data are encouraging, larger trials are needed to confirm efficacy and safety, especially following a prior clinical hold related to concerns over EED inhibitors. Analysts have raised their peak sales forecasts to roughly $600 million with a 50% probability of success, and Fulcrum's cash runway extends into 2027. Market dynamics favor Pociredir due to Pfizer's withdrawal of Oxbryta and slow adoption of gene therapies, creating scarcity value for new oral treatments. Beyond SCD, Fulcrum is developing programs for inherited aplastic anemias, with an Investigational New Drug application for Diamond-Blackfan anemia expected in late 2025. Despite this promise, history shows that small-cap pharma stocks can experience volatile reversals after big gains, so locking in profits while retaining a small position for potential upside on drug results seems prudent. The broader biotech sector, historically avoided by the author, has recently become more attractive due to technological advances and compelling net cash positions, as demonstrated by previous successes like Somalogic. Overall, Fulcrum represents a high-risk, high-reward opportunity in a niche with growing unmet medical needs, but caution and disciplined profit-taking remain essential given the sector's volatility. Fulcrum Therapeutics, Inc. (FULC) is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 21 hedge fund portfolios held FULC at the end of the first quarter which was 23 in the previous quarter. While we acknowledge the risk and potential of FULC as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than FULC but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. This article was originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
