Latest news with #Faslodex
Reuters
3 days 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
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
Yahoo
11-03-2025
- Business
- Yahoo
Pfizer and Arvinas's HER2-breast cancer drug extends PFS in certain patients
Pharma giant Pfizer and Arvinas's human epidermal growth factor receptor 2 (HER2) negative breast cancer therapy, vepdegestrant, has seen mixed results after it was only able to extend progression-free survival (PFS) in certain patients in a Phase III trial. Topline results from the company's Veritac-2 trial (NCT05654623) showed a clinically meaningful improvement in PFS in patients with oestrogen receptor 1-mutant (ESR1m) breast cancer. However, the company said that it was not able to improve PFS in the intent-to-treat (ITT) population. The global randomised study enrolled 624 patients at sites in 26 countries who had previously received treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors alongside endocrine therapy. The trial pitted vepdegestrant against AstraZeneca's Faslodex (fulvestrant). Data on overall survival (OS), a key secondary endpoint, was not yet mature with less than a quarter of the required number of events having occurred. Pfizer describes vepdegestrant as a potential first-in-class investigational oral proteolysis targeting chimera (PROTAC) oestrogen receptor degrader. Developed as part of a $2.4bn partnership between Pfizer and Arvinas, the oral drug was designed for a natural protein disposal system to specifically target and degrade oestrogen receptors. Following the announcement of the mixed results, Arvinas' stock price dropped more than 51% from $17.70 per share down to $8.59 at the time of publication (11 March 10am EST). Arvinas president John Houston said: 'The first Phase III data readout for a PROTAC degrader represents a significant achievement and these data show that vepdegestrant has the potential to provide clinically meaningful outcomes for thousands of patients with metastatic breast cancer whose tumours harbour oestrogen receptor 1 mutations.' It follows after the US Food and Drug Administration (FDA) granted fast track designation for the investigation of vepdegestrant as a monotherapy. Research by GlobalData estimates that by the end of next year, the breast cancer therapy could bring in as much as $75m for the two companies, with that figure expected to rise to $841m by the end of 2030. The World Health Organization (WHO) found that breast cancer caused 670,000 deaths globally in 2022. GlobalData is the parent company of Clinical Trials Arena. Pfizer oncology chief development officer Megan O'Meara said: 'Patients with advanced ER+/HER2- metastatic breast cancer face significant clinical challenges, with limited treatment options following disease progression and the development of resistance to available endocrine therapies. 'This data from the Veritac-2 trial supports the potential of vepdegestrant to give patients whose tumours harbour ESR1 mutations additional time without disease progression, compared to Faslodex.' Elsewhere in the field of HER2 breast cancer, NiKang Therapeutics has concluded the first cohort dosing in the open-label Phase I trial of NKT3964. Meanwhile, Phoenix Molecular Designs has started dosing in the Phase II arm of a trial examining its metastatic breast cancer candidate, PMD-026. "Pfizer and Arvinas's HER2-breast cancer drug extends PFS in certain patients" 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. Sign in to access your portfolio
Yahoo
28-01-2025
- Health
- Yahoo
Genentech's Itovebi combo hits overall survival endpoint in HER2- breast cancer
Genentech Therapeutics's Phase III trial of Itovebi in patients with certain types of metastatic breast cancer has met the gold standard oncology endpoint of overall survival (OS) while also delaying disease progression. Further results from the randomised, double-blind trial (NCT04191499) showed that Itovebi, otherwise known as inavolisib, when used in combination with Ibrance (palbociclib) and Faslodex (fulvestrant) met its secondary endpoint by showing a statistical and clinically meaningful benefit in OS in patients living with PIK3CA-mutated, hormone receptor (HR) positive, human epidermal growth factor receptor 2 negative (HER2) negative breast cancers. This news comes three months after the US Food and Drug Administration (FDA) approved the Itovebi combination as a first-line therapy based on this Phase III trial. The combination therapy is approved for patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer. Primary analysis from the INAVO120 trial was published in December 2023 found the Itovebi combination regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and Faslodex alone. At the time of the primary analysis, data on the secondary endpoint of OS was still immature. In the secondary analysis, the company added that no new safety signals have been discovered since publishing its primary analysis. Chief medical officer for the Roche subsidiary, Levi Garraway, said: 'These findings underscore our ambition to improve survival rates for people with breast cancer. The Itovebi-based regimen has the potential to become the new standard of care for these patients. 'The INAVO120 overall survival results show that the Itovebi-based regimen not only delayed disease progression, but also helped people with advanced HR-positive, PIK3CA-mutated breast cancer live longer.' The INAVO120 trial comes as part of a series of trials examining Itovebi with Ibrance and Faslodex against placebo across a number of HER2- and HR-positive cancers. Of the still ongoing trials, INAVO121 (NCT05646862) is examining the combination treatment following cyclin-dependent kinase 4/6 inhibitor and endocrine combination therapy. The INAVO122 trial (NCT05894239) examines the regimen in combination with HER2 blockade versus dual HER2 blockade. Meanwhile, the INAVO123 trial (NCT06790693) was in combination with CDK4/6i and letrozole. Now, the company has said that a full analysis of the secondary endpoint will be discussed at an upcoming meeting. Research by GlobalData estimates that Itovebi is estimated to earn approximately $164m in sales by the end of 2025, with the drug forecasted to reach blockbuster status, with sales set to rise to $1.3bn by the end of 2030. GlobalData is the parent company of Clinical Trials Arena. Elsewhere in the world of HER2-related cancers, MSD and Eisai have announced mixed results from a Phase III trial of a Keytruda (pembrolizumab) combination as a first-line treatment for patients with HER2 negative gastroesophageal adenocarcinoma. "Genentech's Itovebi combo hits overall survival endpoint in HER2- breast cancer" 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. Sign in to access your portfolio
