AstraZeneca has announced impressive results for its STRIDE regimen, delivering significantly improved outcomes for advanced liver cancer patients. The treatment regimen was evaluated in the ongoing HIMALAYA Phase III study (NCT03298451), conducted with 1324 hepatocellular carcinoma (HCC) patients. Participants were randomised to receive either STRIDE or sorafenib, one of the tyrosine kinase inhibitors that comprise the current standard of care for various liver, kidney, and thyroid cancers. After four years of follow-ups, AstraZeneca announced that STRIDE reduced the risk of death by 22% compared to sorafenib, with 25.2% of patients alive at the four-year mark compared to 15.1% with sorafenib. While a one-in-four survival rate may not be comparable, advanced-stage HCC carries a poor prognosis. Five-year survival rates for the condition are only 7%, one of the lowest across all oncology, so even minor improvements in overall survival can make a major difference. Despite this improvement, adverse events recorded during ...
Chronic kidney disease (CKD) affects around 37 million Americans, but this disease, which does not get the attention other conditions often do, can go undetected for years, boosting the risks of organ failure and even death.AstraZeneca, maker of blockbuster diabetes drug Farxiga that recently nabbed an expanded label in CKD, wants more to be done to find those who have this disease. The pharma cited new, real-world evidence that shows the prevalence of undiagnosed stage 3—moderate—CKD is 85% to 97% across Australia, Brazil, Canada and Spain. The study was shared this month at the European Renal Association 2023 Congress in Milan, Italy. This is a “staggeringly low rate” of diagnosis in CKD, according to an accompanying release from AstraZeneca, with these data showing “that an urgent need exists for improved screening.” Improved screening can lead to earlier diagnosis and thus potentially better outcomes, given that once kidney damage sets in ...
AstraZeneca (AZ) has announced that it will stop its post-marketing study of bleeding reversal agent Andexxa (andexanet alfa) after the trial met its primary endpoint earlier than planned. The phase 4 ANNEXA-I study has been assessing the safety and efficacy of the drug versus standard care in more than 450 patients experiencing an intracranial haemorrhage who have received oral Factor Xa-inhibitor treatment, including apixaban and rivaroxaban. Results from a planned interim analysis of the trial showed that Andexxa-treated patients experienced superior haemostatic efficacy – the ability to limit the expansion of a potentially life-threatening bleed in the brain – compared with the control arm, leading the data monitoring board to recommend that the study be ended. Millions of people worldwide depend on Factor Xa inhibitors to manage their risk of blood clots developing, but these medicines carry a small but significant risk of an acute major bleed. AZ reports that ...
Seeking to launch their respiratory syncytial virus (RSV) prevention antibody for infants later this year, Sanofi and AstraZeneca have cleared one more regulatory hurdle.Thursday, experts on the FDA’s Antimicrobial Drugs Advisory Committee voted 21 to 0 that nirsevimab boasts a favorable benefit-risk profile to protect against RSV-associated lower respiratory disease in infants born during or entering their first RSV season. On a separate question of whether the drug has a favorable benefit-risk profile in children up to 24 months of age who remain vulnerable through their second RSV season, the vote was 19 to 2 in favor of the drug. “Most babies hospitalized with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact,” Sanofi’s executive vice president of vaccines, Thomas Triomphe, said in a Thursday statement. “We are encouraged by the Advisory Committee’s positive ...
AstraZeneca (AZ) has shared positive results from a late-stage study evaluating Tagrisso (osimertinib) as an additional treatment for certain lung cancer patients. The phase 3 ADAURA trial enrolled 682 patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who had undergone surgery to remove their primary tumour. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence. The results, which were presented at the American Society of Clinical Oncology annual meeting, showed that the drug reduced the risk of death by 51% compared to placebo in both the primary analysis population (patients with stages 2 to 3a EGFRm NSCLC) and in the overall trial population (stages 1b to 3a). In the primary analysis population, an estimated 85% of Tagrisso-treated patients were alive at five years compared to 73% in the placebo cohort. In the overall trial population, around 88% of ...
Bayer has blockbuster hopes for prostate cancer med Nubeqa, and a new endorsement from the U.K.’s National Institute for Health and Care Excellence (NICE) provides another milestone toward that goal. After an approval last November to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC), Bayer inked a deal with officials in England to make the drug available to certain patients under an early access program. Now, thanks to NICE’s endorsement in combination with androgen deprivation therapy and the chemotherapy docetaxel, the drug will be available to more patients in England and Wales, Bayer said in a release. Already, a “few hundred” patients with mHSPC have received the drug, according to Bayer. The drug scored its mHSPC approval in England last November thanks to late-stage data showing that the combination cut the risk of death by 32.5% compared with placebo. Previously, the drug had carried a NICE endorsement to treat patients ...
Treatment concerns up to 150,000 patients in England with chronic heart failure The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AstraZeneca’s dapagliflozin. The therapy, also known as Forxiga, is as an option among adults with symptomatic chronic heart failure with mildly reduced or preserved ejection fraction. Currently, there are no disease-modifying treatments for this specific condition and, thus, dapagliflozin becomes the first NICE-recommended treatment for this population. Meanwhile, evidence from a clinical trial demonstrated that adding dapagliflozin to standard care with diuretics effectively decreases the combined risk of dying from cardiovascular causes or the need attend hospital with heart failure. This was compared during the study with placebo in addition to standard care. Helen Knight, director of medicines evaluation at NICE, reflected: “Until now there have been no treatments available to delay or slow the progression of this type of heart failure. “The ...
AstraZeneca’s (AZ) Farixga (dapagliflozin) has been approved for extended use in the US, meaning adult patients with heart failure (HF) can benefit from the treatment regardless of their left ventricular ejection fraction status (LVEF). Farxiga, sold as Forxiga in certain markets, was previously approved in the US for HF patients with reduced ejection fraction (HFrEF) which is equal to or less than 40%. HF affects approximately seven million people in the US and is associated with substantial morbidity and mortality, with chronic HF the leading cause of hospitalisation for those over the age of 65. Roughly half of all HF patients have mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), with few therapeutic options available. As well as the greater risk of death and hospitalisations, patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations. The US Food and Drug Administration’s (FDA) ...
[GSK already has concerns with cancer drug Zejula, which is under scrutiny as a member of the PARP inhibitor class. Not the company has taken a loss in court as it will have to surrender added royalties to AstraZeneca for the drug which rolled up sales of 463 pound sterling ($571 million) last year. (GSK)] When Emma Walmsley took over as CEO at GSK in 2017, one of her first moves was to beef up the company’s oncology portfolio with a $5.1 billion acquisition of cancer specialist Tesaro and its newly approved drug Zejula. The ovarian cancer treatment generated 463 pound sterling ($571 million) in 2022, representing a 17% increase from the previous year. So far, so good, right? Well, not exactly. After losing a patent case in court on Wednesday, GSK will have to surrender a portion of its sales of Zejula to Tesaro’s partner on ...
Cambridge-based biotech company Alchemab has announced a new collaboration with British pharma AstraZeneca (AZ), aiming to accelerate research for prostate cancer. As part of the collaboration, Alchemab and AZ will collaborate on a proof-of-concept study to improve understanding of the ‘fundamental biology’ of prostate cancer. Alchemab will utilise its novel drug discovery platform as a diagnostic tool through the identification of disease biomarkers, with the potential to inform the development of new antibody-based medications. Under the agreement, Alchemab will sequence and explore antibody repertoires in patient samples gathered from a clinical trial of an undisclosed immuno-oncology agent within AZ’s pipeline. Alchemab may also be able to identify antibody sequence patterns that could be used as biomarkers for early detection and patient stratification by classifying patients into two groups – responders and non-responders. The overall purpose of the collaboration is to identify novel and disease-relevant antibodies which may generate therapeutic insights into ...
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