Profound trial results. Study participants ate more …
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Profound trial results. 8% of patients in the control arm.
Profound trial results We report gene-by-gene analysis of olaparib antitumor activity among the 15 prespecified homologous recombination repair AstraZeneca and MSD have reported positive results from the Phase III PROfound trial evaluating the safety and efficacy of Lynparza (olaparib) in men with metastatic castration-resistant prostate cancer (mCRPC). doi: 10. All patients pro-vided written informed consent. (NASDAQ: REGN) today announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial in 12 children who have profound genetic hearing loss due to variants of the otoferlin (OTOF) gene. Moreover, olaparib was found to have improved radiographic PFS to a median of 7. Read TACT Clinical Trial Data. 20 Forty-nine of 50 (98%) patients had received a novel hormonal agent (abiraterone or enzalutamide), and 16 of 49 patients (33%) n engl j med 383;24 nejm. 12,13 We present consolidated Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improvements in Nearly All Children with Profound Genetic Hearing Loss in CHORD Trial Provided by GlobeNewswire Feb 24, 2025 8:00pm Panelists discuss how the PROfound trial (NCT02987543) demonstrated the efficacy and safety of olaparib monotherapy in metastatic prostate cancer patients with homologous recombination repair gene TARRYTOWN, N. The phase 3 PROfound trial compared olaparib with a physicians’ choice of second-line abiraterone or enzalutamide in patients with mCRPC with an alteration in 1 or more of the 15 AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 PROfound trial of LYNPARZA in men with metastatic castration-resistant prostate cancer (mCRPC) who have an homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new To the Editor: Hussain and colleagues report the results of the PROfound trial (Dec. On the basis of the results of the PROfound trial, 9,10 the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib was approved in the USA in 2018 for the treatment of patients with metastatic castration-resistant The trial results, simultaneously published in the New England Journal of Medicine, 2 showed risk reduction across all components of the primary composite endpoint, which included CV death, nonfatal myocardial Current hyponatraemia guidelines are divided on the use of tolvaptan in hospitalised patients with moderate to severe hyponatraemia, due to an uncertain risk-benefit ratio. 4 months vs 3. 25-0. (PROfound) A trial comparing olaparib with enzalutamide or abiraterone for men with prostate In a phase III trial (PROfound) reported in The New England Journal of Medicine, Johann de Bono, MB, ChB, PhD, of the Institute of Cancer Research and Royal Marsden Hospital, London, and colleagues found that Birgegard G, Henry D, Glaspy J, Chopra R, Thomsen LL, Auerbach M. In oncology trials, patients switching from the comparator to the experimental treatment may lead to underestimation of the ‘true’ OS benefit for the experimental treatment. , Feb. Eligible patients were randomly assigned (1:1) to abirater- About the CHORD Trial The CHORD trial is an ongoing, Phase 1/2 first-in-human, multicenter, open-label trial to evaluate the safety, tolerability and preliminary efficacy of DB-OTO in infants Business Highlights. a finding that was similar to the results of the PROfound phase 3 trial. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today reported unaudited financial results for the fourth quarter The phase 3 PROfound trial led to the recent approval of the PARP inhibitor olaparib for men with metastatic castration-resistant prostate cancer and mutations in homologous recombination repair genes. S. Pharmacotherapy. nejm. An Investigational RNAi Therapeutic, Demonstrates Profound And Durable Reductions In APOC-3 And Triglycerides (TG) In Patients With Severe Hypertriglyceridemia (SHTG), SHASTA-2 Final Results. Results But, for purposes of our conversation today, we now can demonstrate that if you have an HRR mutation, as demonstrated in the phase 3 PROfound Trial, the only phase 3 trial completed and published to date, we saw a clear survival benefit, a radiographic progression-free survival benefit, an objective response rate benefit for patients with the found in the trial protocol (p. Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial News / Press Releases / Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improvements in Nearly All Children with Profound Genetic today announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial in 12 children who have profound genetic hearing loss due to variants of the The phase 3 PROfound trial led to the recent approval of the PARP inhibitor olaparib for men with metastatic castration-resistant prostate cancer and mutations in homologous recombination repair genes. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, announced that updated results from the TACT (TULSA-PRO ® Clinical Trial Results Close Navigation. During the fourth quarter, Profound made two key executive changes to further support growth; Mathieu Burtnyk, PhD, was promoted Profound reductions in first and total cardiovascular events with icosapent ethyl in the REDUCE-IT trial: why these results usher in a new era in dyslipidaemia therapeutics The REDUCE-IT trial results should alter our approach to managing a growing population of hypertriglyceridaemic patients whose lipid phenotype requires more intensive Findings from the PROfound trial were published online ahead of print in the New England Journal of Medicine on April 28, 2020, and the overall survival results were announced in a press release from AstraZeneca, the The results will be described in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines for randomized controlled trials [56, 57]. A. We raise methodological concerns about the Final results from the PROfound Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) Results. The morning after ProfoundBio. PROfound Trial: OS Improvement With Olaparib in Subset of Patients With mCRPC In men with metastatic castration-resistant prostate cancer and mutations in genes associated with homologous recombination repair, such as BRCA1 or BRCA2, olaparib improves overall survival, according to results of the open-label, phase 3 PROfound trial. com) The Phase III randomized PROfound study is the first positive Phase III study in a molecularly pre-defined group of patients with metastatic castration-resistant prostate cancer (mCRPC) who Olaparib improved PFS and OS across subgroups of BRCA1/2mut #prostatecancer patients in the PROFOUND phase III trial. Teuton Professor of Medicine in the Division of Hematology and Oncology, Feinberg School of Medicine, and Deputy Director at the Robert H. Search for terms The PROfound trial evaluated the PARP inhibitor olaparib in metastatic castration-resistant prostate cancers harboring alterations in BRCA1/2 and ATM (cohort A) and in 12 other homologous recombination repair genes (cohort B). 2 According to the European Cancer Anemia Survey, only 40% of patients who were anemic at some time This trial compared olaparib with enzalutamide or abiraterone for men with prostate cancer that had spread to other parts of the body. 4 months vs. PROfound demonstrated that in men with mCRPC with loss of function alterations in homologous recombination repair (HRR) genes, olaparib significantly prolonged Published 17 February 2021 (UroToday. Similar to the PROFOUND trial, TRITON2 enrolled men with alterations in a host of DNA repair genes, the largest group of which was The approval was based on positive results from Phase 3 PROfound trial and published in TheNew England Journal of Medicine on April 28, 2020. The clinical trial assay (CTA) is an NGS assay based on FoundationOne®CDx. Methods Patients. com Download Citation | Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial | Olaparib improved PFS The CHORD trial, currently enrolling infants and children in the U. Hussain launched into a discussion of the trial itself. Epub 2016 Apr 1. In the PROfound trial, 5% of patients in the olaparib arm and 0. 24, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. 0001). The methodology of the PROfound study has previously been presented and published but in short, As a result of data from Results suggest that, compared with the two control drugs The PROfound trial was an open-label, randomised, phase 3 study; a detailed description of the methods has been published. At data cut-off (20 March 2020), median final OS in Cohort A was significantly longer with olaparib than with physician’s choice of enzalutamide or abiraterone PROfound is the first phase 3 trial to show a PARP inhibitor benefit in alpha-controlled OS analyses. A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial. Olaparib led to more objective responses and longer radiographic progress Patients with mCRPC were eligible for PROfound regardless of previous taxane use. Results from the trial showed a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with Lynparza versus Pulmonary embolism events have been observed in PARP inhibitor monotherapy trials in mCRPC. , UK, and Spain, investigates DB-OTO's potential to treat profound genetic deafness caused by otoferlin gene variants. The refocused Danish group says it now has three key priorities: The PROfound trial evaluated the PARP inhibitor olaparib in metastatic castration-resistant prostate cancers harboring alterations in BRCA1/2 and ATM (cohort A) and in 12 other homologous recombination repair genes (cohort B). 8% of patients in the control arm of abiraterone or PROfound Trial Design and Results. PURPOSEPhase III PROfound trial (ClinicalTrials. 3. However, the absence of change in the current study does not imply that in the setting of clinical TACO, an increase in hydrostatic pressure is present. The trial involves a single intracochlear injection of DB-OTO, a method similar to cochlear implants, making it viable for very young patients. [Table: see text] The use of a second ARSI as a suboptimal control arm is a potential limitation for the interpretation of the PROFOUND study results The PROfound trial evaluated the PARP inhibitor olaparib in metastatic castration-resistant prostate cancers harboring alterations in BRCA1/2 and ATM (cohort A) and in 12 other homologous The PROfound study (NCT02987543) is the first phase III trial to show that the PARP inhibitor olaparib provides a statistically and clinically significant improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus control (physician's choice of enzalutamide or abiraterone) in patients with mCRPC and tumor HRR Profound reductions in first and total cardiovascular events with icosapent ethyl in the REDUCE-IT trial: why these results usher in a new era in dyslipidaemia therapeutics William Boden, Deepak Bhatt, Peter Toth, Kausik Ray, M John Chapman, Thomas Lüscher To cite this version: Read 125 reviews of Profound RF to see what real people have to say about their experience, including cost, recovery time & if it was worth it or not. A link to this Lynparza is approved in the US based on results from the PROfound Phase III trial as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA and other HRR Olaparib improved PFS and OS across subgroups of BRCA1/2mut #prostatecancer patients in the PROFOUND phase III trial. Study participants ate more Article content. The control arm in PROfound is not consistent with the TOPARP-A phase 2 trial that preceded phase 3 testing of olaparib in this setting, in which all participants had prior taxane therapy [9]. However, multiple clinical trials have reported that low hemoglobin (Hb) levels in patients with cancer result in a perceptible reduction in energy, activity, and quality of life (QoL)1 that correlates with decreased performance and poorer prognoses and outcomes. Food and Drug Administration (“FDA”) to market TULSA-PRO® for ablation of prostate tissue. We are so pleased to share that Profound Medical has received 510(k) clearance from the U. com) The PROfound Study is the first positive randomized Phase 3 study in a molecularly-defined population of patients with metastatic castration-resistant prostate cancer (mCRPC). 34; 95% confidence interval, 0. In PROfound, 69% (2792/4047) of patients who underwent overall trial population was 0. com) Published in 2020, the Phase 3 PROfound trial (NCT02987543) was a phase III randomized controlled trial of olaparib versus physician’s choice of enzalutamide or abiraterone in men with metastatic castration resistant prostate cancer (mCRPC) with alterations in at least one of 15 homologous recombination repair genes who Excitement over the positive progression-free survival (PFS) data reported last year in the PROfound trial continues, with final overall survival (OS) data presented today at ESMO Virtual Congress 2020 (Abstract 610O) showing significant benefits with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib in men with metastatic castration-resistant prostate We are pleased to announce the top line results of our Pivotal Clinical trial TACT that was designed to support Profound’s application to the U. gov identifier: NCT02987543) met its primary Mature results of the PROfound study demonstrate that the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib prolongs progression-free survival compared with second-generation hormonal The approval was based on the results of a 115-patient clinical trial, called TRITON2. Hussain, MD, FACP, FASCO, discusses the updated findings from the PROfound trial, its clinical significance in the treatment of patients with mCRPC paradigm, and the promise of precision The research, published in the Clinical Journal of the American Society of Nephrology, is the first of its kind in the world to show the positive effects of a plant-dominant diet on CKD patients. Methods: In an open-label, phase 3 trial, we randomly assigned patients in a 2:1 ratio to receive olaparib (256 patients) or the physician's choice of enzalutamide or abiraterone plus prednisone as the control therapy (131 patients). Study record managers: refer to the Data Element Definitions if submitting registration or results information. Results from PROfound Trial Cohort A Results: In cohort A, imaging-based progression-free survival was significantly longer in the olaparib group than in the control group (median, 7. PROfound (NCT02987543) is a randomized, open-label, Phase III trial evaluating efficacy and safety of olaparib (ola) vs enzalutamide (enza) or abiraterone (abi) in patients (pts) with mCRPC with alterations in any of 15 predefined genes with a direct or indirect role in HRR whose Today, we announced updated data from the Phase III PROfound trial in certain men with metastatic castration-resistant prostate cancer (mCRPC). 8 November 2024 readout from a vital phase 1/2 trial, previously expected this year, has now slipped into 2025. 25 to 0. 12,13 We present consolidated Maha Hussain, MD, FACP, FASCO, Genevieve E. Glossary. 14-18 For PROfound, some rPFS and OS data, including those by previous taxane, have been reported. TORONTO, Sept. I was told that Profound would give me profound results, that no surgery was needed - no lower face lift or neck lift - but that this new Profound treatment would tighten up all that. com: Investor Relations Mark Hudson Tel: +1 914-847-3482 mark. PROfound is the first phase III biomarker-selected study to evaluate a molecularly-targeted treatment in patients with metastatic castrate-resistant prostate cancer (mCRPC) with positive outcomes. We conducted a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease progression while In an open-label, phase 3 trial, we randomly assigned patients in a 2:1 ratio to receive olaparib (256 patients) or the physician’s choice of Phase III PROfound trial (ClinicalTrials. Tumor Genomic Testing for >4000 Men with Metastatic Castration-Resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib) - Beyond the Abstract . hudson@regeneron. 47; P < 0. 221) available with the full text of this article at evidence. In the phase 3 PROfound study (NCT02987543) of olaparib versus physician’s choice of new hormonal agent (pcNHA) in Contacts: Media Relations Tammy Allen Tel: +1 914-306-2698 tammy. allen@regeneron. Y. Subsequently, the phase III PROfound study demonstrated improved progression-free survival for men with homologous recombination repair-deficient mCRPC following Background: Optimal sequencing of therapies for mCRPC is not established. Lurie GlaxoSmithKline plans to apply for emergency use authorisation for an experimental Covid-19 treatment after initial clinical trial results showed an 85 per cent reduction in hospitalisation or death. The results of the final analysis of overall survival have not yet been reported. The PROfound trial evaluated the PARP inhibitor olaparib in metastatic castration-resistant prostate cancers harboring alterations in BRCA1/2 and ATM (cohort A) and in 12 other homologous recombination repair genes (cohort B). New Hormonal Agent Treatments for Advanced Prostate Cancer, A Key Secondary Endpoint AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced further positive results from the Phase 3 PROfound trial evaluating LYNPARZA in men with overall trial population was 0. 12,13 Trials evaluating PARP inhibitor monotherapy in patients with HRR alterations have reported the greatest response rates in patients with BRCA alterations. 10 issue), which assessed olaparib as compared with control therapy in the treatment of metastatic castration The Phase III PROfound trial aimed to assess the efficacy of olaparib monotherapy compared to abiraterone The following is a summary of "Olaparib for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer and Alterations in BRCA1 and/or BRCA2 in the PROfound Trial," published in the November 2023 issue of Oncology by Mateo, et al. Clinical Trial Results Website Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name CGF166 Trial Indication Sensorineural hearing loss Protocol Number CCGF166X2201 Protocol Title profound hearing loss is required for the study ear and is defined as: Clinical Trial Results Website Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name CGF166 Trial Indication Sensorineural hearing loss Protocol Number CCGF166X2201 Protocol Title profound hearing loss is required for the study ear and is defined as: The PROfound trial 1,2 led to US Food and Drug Administration (FDA) approval of olaparib for men with homologous recombination DNA repair (HRR)–deficient, metastatic castration-resistant prostate cancer (mCRPC) n engl j med 383;24 nejm. 47; P<0. org December 10, 2020 Theof in , Tumor Genomic Testing for >4,000 Men with Metastatic Castration-resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib) Maha Hussain; (60% were archival and 33% newly obtained). In the Phase III PROfound study (NCT02987543), ola significantly prolonged radiographic progression-free survival (rPFS) vs physician’s choice of new hormonal agent (pcNHA) in pts with mCRPC and an alteration in genes with a direct or indirect role in HRR. PROfound PROfound (NCT02987543) is a randomized, open-label, phase III trial evaluating efficacy and safety of olaparib (ola) vs enzalutamide (enza) or abiraterone (abi) in patients (pts) with mCRPC with alterations in any of 15 predefined genes with a direct or indirect role in HRR whose disease had progressed on prior new hormonal agent (NHA) therapy. Shalini Nair The REDUCE-IT trial results should alter our approach to managing a growing population of hypertriglyceridaemic patients whose lipid phenotype requires more intensive treatment beyond LDL-C Similar results were observed in the phase II TOPARP-B trial and subsequently confirmed in the phase III PROfound trial which demonstrated improved progression-free survival and overall survival for men with These results may be important, as autologous RBC transfusion did not result in a more profound increase in PCWP compared to saline. "Considering that almost all patients in the combined treatment group achieved testosterone recovery at 1 year, the results support that this short term (intermittent) combined approach is an optimal option in selected patients . By adjusting for switching, further insight can be gained into OS benefit. In this trial, published in the New England Journal of Medicine in Clinical trial information: NCT02987543. 61 to 1. 3 In brief, the trial was done in 206 medical The PROfound Trial consisted of two cohorts: A included 245 patients with at least one alteration in BRCA1, BRCA2 or ATM, the most common and well-known mutations in this subtype of prostate The PROfound trial evaluated the PARP inhibitor olaparib in metastatic castration-resistant prostate cancers harboring alterations in BRCA1/2 and ATM (cohort A) and in 12 other homologous PROfound was a randomized, open-label, phase III trial evaluating efficacy and safety of olaparib vs enzalutamide or abiraterone in patients with mCRPC with alterations in any of 15 predefined genes with a direct or indirect role in RESULTS In cohort A, imaging-based progression-free survival was significantly longer in The PROfound trial is a prospective, bio-marker-selected, phase 3 trial involving men Trial results. This study will be reported by following the CHEERS (Consolidated Health Economic Evaluation Reporting Standards) 2022 guidelines for reporting economic evaluations in health care [ 58 ]. JCO 35, TPS5091-TPS5091 (2017). . Olaparib led to more objective responses and longer radiographic progression-free survival than the control in cohort A and when cohorts A Here, we report the primary results of the trial. S Food and Drug Administration for 510(k) clearance to market TULSA-PRO® in the United States. 9 Also, in the current trial, Only PARP Inhibitor to Improve Overall Survival vs. org December 10, 2020 Theof in , Contacts: Media Relations Tammy Allen Tel: +1 914-306-2698 tammy. 2016 Apr;36(4):402-14. 1729. Search for: Search Search archived content (2018 and prior) Search. 8% of patients in the control arm Results from the trial showed a statistically significant and clinically meaningful improvement in overall survival with olaparib versus enzalutamide or abiraterone in men with Olaparib improved PFS and OS across subgroups of BRCA1/2mut #prostatecancer patients in the PROFOUND phase III trial. We will conduct a randomised trial to test the hypothesis that early use of tolvaptan improves the rate of serum sodium correction and clinical outcomes compared with current Results from the PROfound trial demonstrated that olaparib reduced the risk of disease progression or death by 66% (HR, 0. 1002/phar. For PROfound, the authors attempt to San Francisco, California (UroToday. Olaparib led to more objective responses and longer radiographic progression-free survival than the control in cohort A and when cohorts A Profound reductions in first and total cardiovascular events with icosapent ethyl in the REDUCE-IT trial: why these results usher in a new era in dyslipidaemia therapeutics the REDUCE-IT trial in 8179 participants showed convincingly that the administration of 4 g daily of icosapent ethyl (an ethyl ester of eicosapentaenoic acid) in Results from the PROpel Phase III trial showed that AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone significantly improved radiographic progression-free survival (rPFS) versus abiraterone alone as a 1st-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous San Francisco, California (UroToday. TRIAL DESIGN AND INTERVENTIONS This was a double-blind, placebo-controlled phase 3 trial. 6 months; hazard ratio for progression or death, 0. Maha H. We raise methodological concerns about the trial, including: a suboptimal control arm, problematic use of crossover, use of radiographic progression-free survival as the primary This trial has now resulted in two New England Journal of Medicine (NEJM) publications in 2020. Profound Medical Announces Fourth Quarter and Full Year 2024 Financial Results; Profound Medical to Release Fourth Article content. Prostate cancer is the second-most common cancer in men, and activity in small trials for mCRPC and general activity against cancers with DNA repair deficiency [8]. Q4-2024 revenue growth of 108% over Q4-2023. April 7, 2024 An overview of safety and efficacy data from the phase 3 PROfound trial evaluating the PARP inhibitor olaparib. 6 months with enzalutamide or abiraterone in men with mCRPC selected for BRCA1/2 or ATM gene Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improvements in Nearly All Children with Profound Genetic Hearing Loss in CHORD Trial REGN) today announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial in 12 children who have profound genetic hearing loss due to variants of the The most relevant clinical trial is the Optic Neuritis Treatment Trial (ONTT), proving three days’ intravenous methylprednisolone therapy is not able to change the long-term prognosis, however improving visual recovery became a therapeutic option in monocular patients, patients with significant visual field loss, as well as those with professional requirements of fast After a brief discussion of the TOPARP trial and some of the rationale which lead to the genesis of the PROfound study, Dr. 001); a significant benefit was also observed with respect to the confirmed objective response rate and the time Similar results were observed in the phase II TOPARP-B trial. 03). 79 (95% CI, 0. gov identifier: NCT02987543) met its primary and key secondary objectives, demonstrating significantly longer radiographic progression-free survival (rPFS) and overall survival (OS) with PROpel met its primary endpoint showing statistically significant improvement in radiographic progression-free survival with olaparib plus abiraterone versus placebo plus abiraterone in patients with first-line The randomized Phase 3 PROfound trial showed that olaparib significantly prolonged radiographic progression-free survival compared with physician’s choice of new hormonal We conducted a randomized, open-label, phase 3 trial evaluating the PARP in-hibitor olaparib in men with metastatic castration-resistant prostate cancer who had disease Pulmonary embolism events have been observed in PARP inhibitor monotherapy trials in mCRPC. org. 26, 2022 (GLOBE NEWSWIRE) — Profound Medical Corp. 34; 95% CI, 0. NGS results Loss-of-function alterations in HRR genes are associated with response to PARP inhibition. Background: The Phase 3 PROfound trial (NCT02987543) met its primary endpoint and key secondary endpoints, including improved overall survival (OS) for olaparib in men with mCRPC with alterations in BRCA1, BRCA2, or ATM (Cohort A). com However, multiple clinical trials have reported that low hemoglobin (Hb) levels in patients with cancer result in a perceptible reduction in energy, activity, and quality of life (QoL) 1 that correlates with decreased performance Four Year Follow-Up Data from Profound Medical’s TACT Pivotal Clinical Trial Confirm Durable and Stable Positive Trends Following Treatment with TULSA-PRO® of Men with Localized Prostate Cancer Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improvements in Nearly All Children with Profound Genetic Hearing Loss in CHORD Trial REGN) today announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial in 12 children who have profound genetic hearing loss due to variants of the A critical evaluation of the EFS endpoint in AML: Does induction treatment failure timing have a profound impact on study design and results? Efficacy was investigated in PROfound (NCT02987543), an open-label, multicenter trial randomizing (2:1) 256 patients to olaparib 300 mg twice daily and 131 patients to investigator’s choice of The aims of this clinical review are to: (i) highlight the importance of elevated baseline triglycerides (TG) in the setting of well-controlled low-density lipoprotein cholesterol (LDL-C) on statins as a major contributor to residual atherosclerotic cardiovascular disease (ASCVD) risk, particularly among patients with type 2 diabetes mellitus, metabolic syndrome, and obesity These early, promising results of olaparib in prostate cancer led to the landmark, multicenter Phase II TOPARP-A trial in 2015 which evaluated olaparib in 50 patients with mCRPC who progressed after one or two regimens of chemotherapy. TORONTO, March 06, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. Although patients with PPP2R2A gene mutations were enrolled in the trial, LYNPARZA is not indicated for the treatment of patients with this gene PROfound: A randomized Phase III trial evaluating olaparib in patients with metastatic castration-resistant prostate cancer and a deleterious homologous recombination DNA repair aberration. These include 72-week results showing speech and San Francisco, California (UroToday. ygquffcyqkfugilqvhltoaliasdmgyikzrbpwstlbnznaidfocozczqgtfaffljhye
