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Yahoo
an hour ago
- Health
- Yahoo
Florida Cancer Specialists & Research Institute introduces liquid biopsy test
Florida Cancer Specialists & Research Institute (FCS) in the US has introduced liquid biopsy, a blood test that rapidly identifies cancerous tumours and circulating cells in the bloodstream. This test may be used to evaluate colorectal, lung, prostate, breast, and blood cancers. Liquid biopsy represents an advancement in cancer diagnosis and treatment, utilising a simple draw of blood to test for circulating tumour DNA (ctDNA). The introduction of liquid biopsy at FCS underscores the practice's focus on expanding its comprehensive genomic testing offerings, thereby improving diagnostic accuracy, guiding physicians in treatment decisions, and the patients' clinical outcomes. FCS claims to have broadened its testing options for the 250 physicians serving more than 102,000 individuals across Florida, since the introduction of next-generation sequencing (NGS) offerings at its centralised in-house laboratory in 2021. The practice has seen over 4.2 million annual visits and recently surpassed over 16,000 molecular tests processed at its Fort Myers lab facility. FCS genetics laboratory associate director Jennifer Gass said: 'Liquid biopsy is especially effective for providing genetic information quickly for various types of advanced cancers to help physicians assess and better target treatments that may work best and monitor patient response. 'Additionally, because it is minimally invasive and easy to repeat on an ongoing basis, liquid biopsy is significantly more comfortable for patients.' The expansion of the NGS testing menu at the FCS includes the addition of homologous recombination deficiency (HRD) testing, which analyses tumour DNA to determine potential treatment responses to poly (ADP-ribose) polymerase (PARP) inhibitors. This class of drugs specifically targets cancer cells. Other additions include a small heme NGS panel that identifies mutations related to myeloproliferative neoplasms and a quantitative assay for monitoring BCR-ABL gene fusions post-treatment in specific blood cancers. "Florida Cancer Specialists & Research Institute introduces liquid biopsy test" was originally created and published by Medical Device Network, 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
7 days ago
- Business
- Yahoo
ASCO 2025: GSK's Jemperli fails to show OS benefit in 1L advanced ovarian cancer
At the American Society of Clinical Oncology (ASCO) Annual Meeting 2025, held from 31 May to 3 June in Chicago, Illinois, updated efficacy and safety data from the international, double-blind, randomised Phase III FIRST clinical trial were presented on 1 June. The trial evaluated the combination of GSK's Jemperli (dostarlimab), a monoclonal antibody targeting programmed cell death protein 1, and Zejula (niraparib), a poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with platinum-based chemotherapy (PtCh) as a first-line therapy in patients with stage III and IV epithelial ovarian cancer (OC). OC is a deadly gynaecological malignancy, with approximately 90% of cases classified as epithelial. According to GlobalData's Ovarian Cancer: Opportunity Assessment and Forecast report, the number of diagnosed incident cases of OC in the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US) is expected to rise from 67,762 in 2025 to 71,308 by 2032. In the FIRST/ENGOT-OV44 study, a total of 1,138 patients with advanced OC were randomised (1:1:2) to experimental arm 1 (PtCh + placebo and placebo maintenance; dropped from the study due to PARP inhibitor approval), arm 2 (PtCh + placebo and Zejula maintenance; n=385), and comparator arm 3 (PtCh + Jemperli and Jemperli/Zejula maintenance; n=753). The efficacy of arms 2 and 3 (intention-to-treat population) was evaluated based on the primary endpoint - investigator-assessed progression-free survival (PFS). The PFS showed a statistically significant difference between arm 3 and arm 2 (median 20.6 months versus 19.2; hazard ratio [HR] 0.85, 95% confidence interval [CI], 0.73–0.99, P = 0.0351), with a median duration follow-up of 53.1 months. The key secondary endpoint, overall survival (OS), had reached 57% maturity and was not statistically significant (median 44.4 versus 45.4 months; HR 1.01, 95% CI, 0.86–1.19, P = 0.9060). In the maintenance period, treatment-related adverse events above Grade 3 were reported in 41.1% of patients in arm 3 and 37.2% in arm 2. The study concludes that adding Jemperli to PtCh and Zejula provides a statistically significant but clinically modest PFS benefit, with no improvement in OS for newly diagnosed advanced OC patients. The result was not unexpected, as immune checkpoint inhibitors have shown limited efficacy in OC, which is considered poorly immunogenic. At the end of 2024, Merck & Co's Keytruda (pembrolizumab) and AstraZeneca's Lynparza (olaparib) also failed to meet expectations in the KEYLYNK-001 study as a first-line therapy for OC, showing no OS benefit, similar to findings from the FIRST/ENGOT-OV44 study. Currently, no anti-PD-(L)1 therapies are approved for OC, and demonstrating a positive OS outcome is critical to gaining market share in this broad indication. A key difference between the two studies lies in patient selection. KEYLYNK-001 enrolled patients with breast cancer gene (BRCA) mutations, whereas the FIRST/ENGOT-OV44 trial included all-comers. To improve its chances of success, GSK made multiple modifications to the FIRST/ENGOT-OV44 trial design, including delaying readouts by several years. Initially, the primary endpoint was PFS in PD-L1-positive patients. In 2020, it was split into two groups, PFS in all-comers and PD-L1 expressers, before ultimately shifting the focus solely to all-comers. Another concern is the Jemperli and Zejula combination in the second-line setting for OC. A Phase III trial (NSGO-AVATAR) evaluating this combination was withdrawn due to a lack of financial support, suggesting GSK may not be optimistic about its prospects in the broader gynaecological cancer space. According to GlobalData's analyst consensus forecast, global sales for Jemperli and Zejula are projected to reach $2.56 billion and $1.26 billion, respectively, by 2030. In comparison, AstraZeneca's Lynparza and blockbuster PD-1 blocker Merck's Keytruda are expected to reach global sales of $2.4 billion and $22.71 billion, respectively. GSK acquired both Jemperli (co-developed with AnaptysBio) and Zejula through its $5.31 billion acquisition of Tesaro in 2019. After the FDA's accelerated approval in 2021 for patients with mismatch repair-deficient endometrial cancer as a second-line treatment, Jemperli has become a cornerstone of GSK's cancer portfolio alongside Zejula. In its most recent financial report, Jemperli sales increased 15% to $285 million in Q1 2025 due to broad-label expansion in first-line endometrial cancer regardless of biomarker status in the US. However, Jemperli holds a distinct advantage with its OS data over its main competitor, Keytruda, which also secured broad expansion in 2024. To expand Jemperli's success beyond endometrial cancer, GSK will need to wait for positive Phase III results from other ongoing clinical trials: GALAXIES LUNG 301, AZUR-2, MITO 33, JADE, ROCSAN and COSTAR Lung. "ASCO 2025: GSK's Jemperli fails to show OS benefit in 1L advanced ovarian 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. 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
Yahoo
03-06-2025
- Business
- Yahoo
J&J data support earlier use of combo pill in prostate cancer
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic mutations, according to newly unveiled data from a Phase 3 clinical trial. Results from this trial, named Amplitude, were released Tuesday at the American Society of Clinical Oncology's meeting in Chicago. They could potentially expand the number of people able to receive J&J's Akeega, a pill that combines the active ingredients from the medicines Zejula and Zytiga. Akeega, along with hormone therapy, kept men with so-called BRCA mutations from getting sicker for longer than Zytiga and hormone therapy, reducing the relative risk of disease progression by nearly half. The combination also reduced by 56% the risk that BRCA-positive participants in the study experienced symptoms of disease progression. Akeega is already approved for men whose disease stops responding to hormone therapy if they have BRCA mutations, which often signal a more aggressive cancer. This stage of disease, classified as 'castration resistant,' is considered to be advanced. Akeega's constituent drug components target the proteins PARP and CYP17, respectively. Drugs aimed at CYP17 have been used in prostate cancer for more than a decade, while PARP inhibitors are more recent arrivals. However, in prostate cancer, PARP blockers are largely used in the castration-resistant setting, where testosterone suppression no longer keeps the disease in check. Some physicians and drugmakers have explored moving treatment to early-stage disease as a way of helping patients live longer. Amplitude was set up to test that hypothesis. 'The challenge is that when we use PARP inhibitors as monotherapy at the end of the treatment sequence, resistance rapidly develops, and the median time to radiographic progression-free survival is shorter than 12 months,' said Gerhardt Attard, a professor of medical oncology at University College London and lead author of the study, in a press conference presenting the data. 'This group of patients have poor outcomes, significantly worse outcomes than other patients.' Bradley McGregor, a genitourinary specialist with Dana-Farber Cancer Institute, said the study results will help clear up debate over where PARP inhibitors fit into treatment of people with hormone-sensitive disease. 'This data is quite compelling for the BRCA 1/2 patients where that magnitude of benefit is higher,' he said. Amplitude enrolled men with a broader set of mutations to homologous recombination repair, or HRR, genes, of which BRCA is one. The benefit in the overall population was smaller, with Akeega reducing the risk of radiographic progression by 37% and symptomatic progression by half. Akeega is currently approved only for the narrow BRCA-mutated population. Of the PARP inhibitors on the market, only AstraZeneca's Lynparza has won clearance for the broader HRR population, but its use is reserved for castration-resistant disease. Mark Wildgust, J&J's global medical affairs vice president for oncology, said the HRR results from Amplitude should stimulate some discussion with the Food and Drug Administration. The company must keep working with regulators 'to see if there is room or comfort to expand to that broader population,' he said. Trial investigators also analyzed results by specific HRR mutations beyond BRCA. With some, like one called PALB2, patients didn't see any benefit, Wildgust said. 'I think with smaller patient groups, it's a bit more difficult,' he added. Physicians will need to be able to identify the patients most likely to benefit, should Akeega gain an expanded approval in earlier-stage prostate cancer. 'You don't know if you don't test,' McGregor said. Akeega first won approval in 2023. Johson & Johnson didn't report annual sales for the drug in 2024. GSK has some rights to Zejula, Akeega's PARP-inhibiting ingredient, by way of its 2019 acquisition of the drug's developer, Tesaro Bio. J&J had previously licensed rights to niraparib in prostate cancer specifically, allowing it to market Akeega.
Medscape
29-05-2025
- Business
- Medscape
FDA Slams Pfizer for Talzenna Biomarker-Free Push
Pfizer was taken to task at a recent meeting of the US Food and Drug Administration (FDA)'s Oncologic Drugs Advisory Committee (ODAC) for attempting to expand the use of its prostate cancer drug talazoparib (Talzenna) to men lacking a key biomarker without providing sufficient evidence of benefit. 'It's tantamount to somebody shooting an arrow on the wall and then painting a target around it,' and that the attempt 'is not consistent with a large pharmaceutical company presentation to an advisory committee,' said Richard Pazdur, MD, head of FDA's Oncology Center of Excellence, during the May 21 meeting. The FDA approved the poly ADP ribose polymerase (PARP) inhibitor in June 2023 in combination with enzalutamide for men with homologous recombination repair (HRR) mutated metastatic castration–resistant prostate cancer based on a progression-free survival (PFS) benefit vs placebo in the TALAPRO-2 trial. The application for a mutation-agnostic indication was filed in December 2024 after the company reported better overall survival (OS) not only in men who had the mutation but also in 805 individuals whose HRR mutation status wasn't known at baseline. In an exploratory analysis, the company found a trend toward better OS among the men in the group who didn't have the mutation. Pfizer is seeking an 'all comers' approval based on the results; if granted, the indication for talazoparib would effectively be expanded to include the 70% of patients with metastatic castration–resistant prostate cancer who are HRR mutation free. Study Design and Increased Toxicity Among FDA's Concerns Among FDA's concerns, is that agency analysts found no OS benefit among nonmutated men when they used a different HRR status measurement than Pfizer (HR, 0.99; 95% CI, 0.67-1.47). They also noted that adding talazoparib to enzalutamide markedly increases toxicity; approximately 40% of men on the combination, for instance, require blood transfusions for anemia. The risks mean that the benefit of treatment must be shown to be substantial. However, the FDA's main concern with Pfizer's efforts is that TALAPRO-2 wasn't specifically designed and powered to show that talazoparib works in men who don't have an HRR mutation. There was no prespecified alpha-controlled testing plan, meaning that 'the favorable trend in [radiographic] PFS and OS in this subgroup can be a random false positive,' the agency said in a meeting document. 'To put the elephant in the room,' Pazdur explained, Pfizer's attempt to gain a mutation-agnostic indication based on TALAPRO-2 'is like somebody coming to us with a randomized study, having it completed, and saying 'oops, I forgot to do a statistical analysis plan.' We do not have confidence' in the results. 'This is not just a pin-headed issue of statistics,' he continued. 'It's really where the rubber meets the road. As a federal agency, we have to protect the patient's rights,' and 'people have a right to know' how well a treatment is expected to work for them. FDA presenters noted instances of studies with promising subgroup findings like TALAPRO-2 that fell apart in later randomized trials. That's why to expand an indication to include 'a huge' number of new patients, 'you need robust proof,' Pazdur said. Pfizer argued during the meeting that the efficacy and safety of talazoparib support the indication expansion. Panellists Voted Unanimously Against Use Expansion ODAC was convinced by the FDA's arguments. The eight panellists voted unanimously that TALAPR0-2 is not sufficient to conclude a favorable benefit-risk profile for talazoparib in patients with prostate cancer who aren't HRR mutated. They also agreed with FDA's broader assertion that cancer drug 'efficacy should be formally evaluated in a biomarker-negative population when the biomarker is predictive of response and the prevalence of the biomarker-negative group is high.' 'This is such an important question across all oncology,' said Panellist Neil Vasan, MD, PhD, a medical breast oncologist at New York University, New York City. 'We need to commit to formally evaluating whether targeted therapies benefit patients without the biomarker and not try to ascertain this in some sort of ad hoc way,' he said. As for the benefit of talazoparib in men who don't have an HRR mutation, 'we just don't know from this dataset,' said Heidi McKean, MD, a community oncologist in Sioux Falls, South Dakota. FDA usually follows ODAC's advice.
Egypt Today
11-05-2025
- Business
- Egypt Today
OECD praises Egyptian reforms in latest report
Cairo – May 11, 2025: A recent OECD report has lauded Egypt's strides in reforming its public sector, highlighting progress made under the revamped Egypt Vision 2030 and the updated Public Administration Reform Plan (PARP). The assessment points to major institutional improvements, particularly in digitizing government services, modernizing the civil service, and advancing gender and youth inclusion in policymaking. Despite these achievements, the OECD emphasized the importance of adopting a unified, government-wide strategy to strengthen coordination and ensure that decisions are guided by robust data and analysis. These frameworks, it noted, offer a strong foundation for long-term institutional transformation, but continued momentum and improved coordination across government are essential. Despite clear progress, the OECD emphasized that further work is needed to ensure these ambitious reforms meet citizens' needs and translate into tangible outcomes. On implementation challenges, the OECD stressed the importance of empowering the Ministry of Planning, Economic Development, and International Cooperation (MPEDIC) to better coordinate across sectors. It noted, 'With the present transition to a new planning system, it will be necessary to enhance and formalize co-ordination arrangements with relevant sectors to strengthen the alignment of mid-term programs and sectoral strategies with the strategic objectives outlined in Egypt Vision 2030.' The Central Agency for Organization and Administration (CAOA), which leads implementation of the PARP, was recognized for spearheading reforms. The OECD stated, 'Egypt has made progress towards a more modernized and fit-for-purpose public administration through various priority initiatives targeting the effectiveness of public institutions, digitalization, civil service and public services.' Still, the report urged CAOA to 'translate its strategic objectives into action plans, enhance co-ordination mechanisms and bolster capabilities to steer, co-ordinate, implement and monitor reforms across sectors and levels of government.' The report also highlighted Egypt's digitalization efforts through the Digital Egypt strategy, describing them as 'significant strides using digital solutions to improve the efficiency, accessibility and transparency of public services and procedures.' Yet, it cautioned that 'these strategic frameworks should provide details on how objectives within Digital Egypt can be operationalized.' On transparency and citizen engagement, the OECD noted that Egypt's constitution enshrines the right to access information, but progress remains incomplete: 'More efforts are needed to promote transparency, notably by proactively disclosing information in a systematic manner through a more coordinated and institutionalized approach, until a law on the right of access to information is adopted.' The report also encouraged broader public participation, urging Egypt to 'enhance citizen and stakeholder participation by establishing more impactful councils, conferences and advisory boards at the national and local levels; and exploring innovative participatory processes, including digital participation.' In terms of inclusion, the OECD acknowledged advances in gender and youth policies but recommended bolder steps. It advised the government to 'further integrate gender and youth mainstreaming in sectoral policy planning and in the PARP, as well as to promote women's and youth representation in the public sector.' Additionally, the report called for a dual strategy to 'target specific gender gaps while integrating gender equality across all policies.' The OECD concluded by affirming Egypt's potential to lead effective and inclusive governance reform: 'The OECD Public Governance Review of Egypt aims to help the Government translate its ambitious reforms into more effective, coordinated, evidence-based and citizen-driven policy outcomes.'
