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Yahoo
29-07-2025
- Business
- Yahoo
Celcuity shares triple on late-stage results for breast cancer therapy
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Biotechnology firm Celcuity said Monday a late-stage trial testing its experimental breast cancer therapy in combination with other drugs succeeded, positioning the Minneapolis-based company to submit an approval application to the Food and Drug Administration later this year. Treatment involving the biotech's drug, called gedatolisib, significantly reduced the risk of disease progression or death in patients with a certain kind of advanced breast tumor that continued to grow despite initial therapy. Researchers observed this progression-free survival benefit in both patients given a 'doublet' drug combination including gedatolisib and a 'triplet' combination. In a statement, Celcuity said the trial achieved 'several new milestones' in testing of treatments for breast cancer that's positive for hormone receptors but negative for another protein called HER2. Co-principal investigator Sara Hurvitz, head of the hematology and oncology division at the University of Washington's Department of Medicine, called the results 'potentially practice-changing' in the company's statement. With results in hand, Celcuity plans to file in the fourth quarter for FDA approval. Shares in the company tripled in early trading Monday, before settling back to trade higher by almost 200%. The share price gain inflated Celcuity's market value to about $1.5 billion. Celcuity's study enrolled patients with HR+, HER2- tumors that tested negative for common mutations in a gene called PI3KCA. In one group, the company paired gedatolisib with Pfizer's Ibrance and AstraZeneca's Faslodex, which is available as generic fulvestrant. Treatment with the triplet reduced the risk of disease progression by 76% compared to fulvestrant alone. Progression-free survival reached a median of 9.3 months in the triplet group versus just 2 months for those on fulvestrant. Given with just fulvestrant, gedatolisib treatment reduced progression by 67%, leading to a median progression-free survival of 7.4 months. The company said patient discontinuation rates due to treatment-related adverse events was lower in this study than in Phase 3 trials for approved drug combinations for this patient population. Full data from the trial will be presented at an upcoming medical conference later this year. Andrew Berens, an analyst at Leerink Partners, wrote in a client note Monday that the data 'are likely clinically meaningful across multiple subgroups' and provide rationale to use Celcuity's drug as a second-line breast cancer treatment. 'The 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm-shifting results,' claimed Igor Gorbatchevsky, chief medical officer of Celcuity, in a statement. Other approved drug combinations in the second-line setting are supported by data showing lower median progression-free survival, of about two to four months, compared to the doublet and triplet regimens using gedatolisib. Celcuity expects to have data for gedatolisib in breast cancer patients with PIK3CA mutations by the end of this year. Recommended Reading Full Arvinas, Pfizer data confirm potential, limits of 'Protac' drug in breast cancer 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
Mint
28-07-2025
- Business
- Mint
Celcuity's triple cancer drug combo beats AstraZeneca in halting cancer progression, shows study
Celcuity said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer, sending the biotech firm's shares surging more than twofold in premarket trading. The drug, gedatolisib, in combination with Pfizer's Ibrance and AstraZeneca's endocrine therapy Faslodex, reduced the risk of disease progression or death by 76%, compared to Faslodex alone in previously treated HR /HER2- advanced breast cancer patients in a late-stage study. HR /HER2- breast cancer accounts for about 70% of all breast cancers. The combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex. Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' Afinitor and AstraZeneca's Truqap. The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, Celcuity said, without offering further details. The study also showed that a double combination of gedatolisib and Ibrance reduced the risk of disease progression or death by 67%, compared to Faslodex. This combination increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex. Celcuity plans to report full results from this late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year. It expects to apply for U.S. marketing approval in the fourth quarter. Shares of the Minnesota-based firm jumped nearly 114% to $29.4 before the bell.
Reuters
31-05-2025
- 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
23-05-2025
- Business
- Yahoo
ASCO25: Roche's Itovebi combo reduces risk of death in breast cancer by 33%
Roche's blockbuster vision for phosphoinositide 3-kinase (PI3K inhibitor) Itovebi (inavolisib) has been dealt a boost after the drug demonstrated further positive overall survival (OS) data in a common subtype of breast cancer. In combination with Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and anti-oestrogen drug Faslodex (fulvestrant), Itovebi reduced the risk of death by 33% in patients with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer that has grown during or after hormone therapy treatment. The new OS results came from the Phase III INAVO120 study (NCT05646862) evaluating the triple therapy compared to Ibrance and Faslodex alone. Roche published an abstract containing the data ahead of a presentation at the American Society of Clinical Oncology (ASCO) 2025 meeting taking place from 30 May to 3 June in Chicago, Illinois. Itovebi won US Food and Drug Administration (FDA) approval in this breast cancer indication based on INAVO120's data late last year, although full analysis of the OS has only been completed by Roche now. The study, which enrolled 325 patients, saw Roche's Itovebi combination led to a median OS of 34 months compared to 27 months for those who took a placebo along with Ibrance and Faslodex. The median follow-up was just under three years. The results consolidate previous data that showed adding Itovebi to the treatment regimen more than doubled progression-free survival (PFS) to 15 months. With the full analysis now available, Roche has updated this to 17.2 months, compared to the 7.3 months in the comparator arm. Coupled with the OS data, the results are a landmark moment in the P13KCA landscape. No other pharma company has developed a candidate that reaches the 33% Itovebi has achieved. For example, rival PI3K inhibitor Piqray developed by Novartis, failed to produce a statistically significant difference in OS in breast cancer patients with a PIK3CA mutation. Piqray is FDA-approved as a second-line therapy option, whereas Itovebi is a first-line treatment. HR-positive, HER2-negative breast cancer is the most common subtype of breast cancer. About 40% of these patients have a mutation in the PIK3CA gene. PI3K inhibitors have long been troubled by safety concerns. Roche's Itovebi is no different, with 90.7% of patients experiencing Grade 3 or 4 adverse events (AEs). However, a high rate was also seen in the placebo/Ibrance/Faslodex arm – 84.7%. Hyperglycaemia was an AE singled out in the analysis, being particularly prevalent in the Itovebi group at 63.4%, versus 13.5% in the other arm. Backed by previous survival data, Roche has high hopes for Itovebi, forecasting peak sales of $2.3bn. Analysis by GlobalData, which goes up to 2031, has forecast peak sales of $1.4bn. GlobalData is the parent company of Pharmaceutical Technology and Clinical Trials Arena. 'The INAVO120 trial has identified a targeted treatment regimen that meaningfully improves survival in patients with untreated PIK3CA-mutated hormone receptor-positive metastatic breast cancer – a big step forward for these patients,' said Jane Lowe Meisel, co-director of Breast Medical Oncology at the Winship Cancer Institute of Emory University School of Medicine, and an ASCO Expert in breast cancer. "This study illustrates the importance of genomic testing at the time of diagnosis of hormone receptor-positive metastatic breast cancer so that patients with PIK3CA mutations who qualify for this approach can be readily identified.' "ASCO25: Roche's Itovebi combo reduces risk of death in breast cancer by 33%" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
11-04-2025
- Health
- Yahoo
AstraZeneca's oral breast cancer drug Truqap greenlit for NHS use
AstraZeneca's Truqap (capivasertib) has been approved for use by the National Health Service (NHS) in England and Wales, providing a new targeted therapy option that significantly increases progression-free survival (PFS) in breast cancer patients. National Institute for Health and Care Excellence (NICE), the spending watchdog for the NHS, has recommended the drug to be used in combination with AstraZeneca's already-marketed breast cancer drug Faslodex (fulvestrant). Adults with hormone receptor (HR)-positive HER2-negative breast cancer that has one or more PIK3CA, AKT1 or PTEN gene alterations and is locally advanced or metastatic are eligible for the therapy. NICE estimates around 1,100 patients will be able to take the new twice-a-day tablet, with London's Institute of Cancer Research (ICR) forecasting that the combo therapy will eventually benefit around 3,000 a year. Truqap will likely become a key revenue driver for AstraZeneca. The drug is forecast to reach blockbuster status by 2027, whilst 2031 global sales are expected to hit nearly $2bn, as per GlobalData's Pharma Intelligence Centre. As well as the UK, Truqap is also approved in the US, the European Union (EU), and Japan, amongst others. GlobalData is the parent company of Pharmaceutical Technology. The HR-positive HER2-negative breast cancer drug market also includes Pfizer's Ibrance (palbociclib), Eli Lilly's Verzenio (abemaciclib), and Novartis' Kisqali (ribociclib). Breast cancer is the most common cancer in the UK, affecting one in seven women. Treatments have progressed over the past few decades, meaning 75% of patients survive for 10 years or more after diagnosis. HR-positive HER2-negative breast cancer is the most common type of breast cancer. Results from the Phase III CAPItello-291 trial (NCT04305496) showed that Truqap doubled the time it took for cancer to progress in 708 women with HR-positive HER2-negative breast cancer patients. The median PFS was 7.3 months in those who received Truqap and Faslodex, compared to 3.1 months in patients who received hormone therapy alone. The NHS availability of Truqap is a 'triumph' according to Professor Kristian Helin, chief executive of ICR. "This announcement is a triumph that will improve treatment for these patients with the most common type of advanced breast cancer. Around half of patients with this kind of breast cancer have mutations in one or more of the genes and for these patients, Truqap can halt disease progression. I'm delighted that access to the drug is being expanded to NHS patients in England and Wales who are in desperate need of better options,' Professor Helin commented. Patients with advanced HR-positive HER-2 negative breast cancer in the UK are currently offered the option to continue Faslodex or chemotherapy. Faslodex on its own is often ineffective and chemotherapy carries side effects, the ICR stated. 'People with advanced breast cancer would value treatments like [Truqap] that can be given when limited options exist and because it may delay the need for chemotherapy and its associated side-effects,' NICE's director of medicines evaluation Helen Knight said. Truqap works by inhibiting all three isoforms of the AKT protein. AKT kinases enable cancer cell growth and multiplication. NICE said that whilst there have been no clinical trials directly comparing the new combo therapy to existing approved regimens, indirect comparisons suggest non-inferiority. The recommendation by NICE represents a U-turn after the agency initially rejected the therapy due to uncertainties over its cost-effectiveness. Breast Cancer Now's chief executive Claire Rowney said this meant 'patients faced unnecessary delays in accessing' the treatment. She added that 'NHS England must now put in place prompt genetic testing to ensure those eligible to receive [Truqap] without further delay.' "AstraZeneca's oral breast cancer drug Truqap greenlit for NHS use" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
