Tag: mCRPC

Lantheus Holdings And POINT Biopharma Announced Lu-PNT2002 Phase 3 SPLASH Study Results

(RTTNews) – Lantheus Holdings, Inc. (LNTH) and POINT Biopharma Global Inc. have jointly announced that the Phase 3 SPLASH study evaluating the efficacy and safety of Lu-PNT2002, has met its primary endpoint. Lu-PNT2002 is a PSMA-targeted, lutetium 177-based radioligand therapy (RLT) candidate, in patients with metastatic castration-resistant prostate cancer (mCRPC)…

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Expert Guidelines Detail Optimal Sequencing of Emerging Therapies for Metastatic Castration-Resistant Prostate Cancer, Journal Club

Read the Full Video Transcript Rashid Sayyid: Hello everyone and thank you for joining us in this UroToday recording. I’m Rashid Sayyid, the Urologic Oncology Fellow at the University of Toronto, and along with Zach Klaassen, Associate Professor Program Director at Wellstar MCG Health, we’ll be discussing the recently amended…

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Serial Next Generation Sequencing and the Role of PARP Inhibitor Therapy in 2024

(UroToday.com) The 2023 Society of Urologic Oncology (SUO) annual meeting held in Washington, D.C. between November 28th and December 1st, 2023, was host to a prostate cancer course. Dr. Alan Bryce provided an overview of the use and application of serial next generation sequencing (NGS) in the castrate-resistant prostate cancer disease…

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Phase 3 Clinical Trials with ODM-208 (MK-5684) posted to

ORION CORPORATION INVESTOR NEWS 21 NOVEMBER 2023 at 08:30 EET                      Phase 3 Clinical Trials with ODM-208 (MK-5684) posted to ClinicalTrials.gov database Two new Phase 3 clinical trials to evaluate the safety and efficacy of ODM-208 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) have been posted to the…

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Phase 3 study launches exploring TLX591 in mCRPC

The first patient has been dosed in the phase 3 ProstACT GLOBAL study (NCT04876651) exploring the investigational prostate-specific membrane antigen (PSMA) targeting radio-antibody drug conjugate TLX591 (177Lu-rosopatamab tetraxetan) in patients with PSMA-positive metastatic castrate-resistant prostate cancer (mCRPC), announced Telix Pharmaceuticals, the developer of the agent, in a news release.1 “Dosing…

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Whole genome sequencing in high-grade cervical intraepitheli… : Medicine

1. Introduction Cervical cancer (CC) is the third most common cancer in women worldwide and has a high mortality rate among women. In 2008, CC was responsible for 275,000 deaths, thereby being the fourth leading cause of cancer death in females worldwide.[1,2] In China, CC is the second most…

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2023-11-07 | NDAQ:ARVN | Press Release

– Enrollment continues in the 2L Phase 3 VERITAC-2 trial and study lead-in for the VERITAC-3 1L Phase 3 trial with vepdegestrant; Top-line data readout for VERITAC-2 remains on-track for 2H 2024 – – Bavdegalutamide mCRPC data presented at ESMO showed median rPFS of 11.1 months in patients with AR…

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Impact of germline DNA repair gene variants on prognosis and treatment of men with advanced prostate cancer

In this study, we demonstrate an independent effect of germline DNA repair gene variants on the outcomes of patients with advanced PC. Despite carrier numbers being limited, we were able to identify germline DRG carrier status as an independent prognostic factor for PFS on first-line ARSI treatment, time to progression…

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177Lu-PSMA-617 drug shortage is resolved, FDA determines

The FDA has marked the 177Lu-PSMA-617 (Pluvicto) drug shortage status as resolved given unconstrained supply of the prostate cancer agent, announced Novartis, the developer of the therapy, in a news release.1 177Lu-PSMA-617 was approved in 2022 based on findings from the phase 3 VISION trial. According to the release, Novartis…

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Dr. Sartor shares phase 3 trial data on 117Lu-PSMA-617 in mCRPC

In this video, Oliver Sartor, MD, highlights findings from the phase 3 PSMAfore (NCT04689828) trial exploring 177Lu-PSMA-617 in patients with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC), which he presented at the 2023 European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain. Sartor is the director of radiopharmaceutical trial…

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Phase 3 Trial Results Show Lutetium Can Reduce Risk of Disease Progression in Patients With Prostate Cancer

Data from the phase 3 clinical trial PSMAfore (NCT04689828) show lutetium (Pluvicto; Novartis) met its primary endpoint with a clinically meaningful and statistically significant benefit in radiographic progression-free survival (rPFS) in patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen receptor pathway inhibitor (ARPI)…

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PSMAfore Phase 3 Trial of [177Lu]Lu-PSMA-617 in Taxane-Naive Patients with Metastatic Castration Resistant Prostate Cancer

(UroToday.com) The 2023 ESMO annual meeting included a Presidential session, featuring a presentation by Dr. Oliver Sartor discussing results of PSMAfore, a phase 3 trial of 177Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 is a targeted radioligand therapy for PSMA-positive mCRPC with the following mechanism of…

Continue Reading PSMAfore Phase 3 Trial of [177Lu]Lu-PSMA-617 in Taxane-Naive Patients with Metastatic Castration Resistant Prostate Cancer

rPFS End Point Met with 177Lu-PSMA in Phase 3 Trial for mCRPC

PC-3 human prostate cancer cells: © heitipaves – stock.adobe.com The primary end point of radiographic progression-free survival (rPFS) was met in the phase 3 phase 3 PSMAfore (NCT04689828) trial investigating 177-Lu-PSMA (prostate-specific membrane antigen)-617 (Pluvicto) in patients with metastatic castration-resistant prostate cancer (mCRPC) who were taxane-naïve.1 The data were presented…

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177Lu-PSMA-617 meets rPFS end point in phase 3 trial for mCRPC

Results from the phase 3 PSMAfore (NCT04689828) trial indicate that treatment with 177-Lu-PSMA [prostate-specific membrane antigen]-617 (Pluvicto) met its primary end point of radiographic progression-free survival (rPFS) and showed a favorable safety profile in patients with metastatic castration-resistant prostate cancer (mCRPC) who were taxane-naive.1 The data were presented at the…

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Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in Overall Survival in Patients with mCRPC with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone

Niraparib and abiraterone acetate plus prednisone combination therapy also showed clinically relevant improvement versus standard of care in time to symptomatic progression and time to cytotoxic chemotherapy MADRID, Oct. 22, 2023 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis (FA) of…

Continue Reading Final Multivariate Analysis from the Phase 3 MAGNITUDE Study Shows Trend Toward Improvement in Overall Survival in Patients with mCRPC with BRCA Alterations Treated with Niraparib and Abiraterone Acetate Plus Prednisone

Survival Benefit Shown With Niraparib Plus Abiraterone in BRCA+ mCRPC

Kim Nguyen N. Chi, MD, FRCPC Increased overall survival (OS) was demonstrated with niraparib (Zejula) plus abiraterone acetate (Zytiga) and prednisone (AAP) vs AAP alone in patients with BRCA1/2-mutated (BRCA+) metastatic castration-resistant prostate cancer (mCRPC), according to the phase 3 MAGNITUDE trials (NCT03748641) updated data presented at the ESMO Congress…

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Pembrolizumab plus Enzalutamide for Patients with Metastatic Castration-Resistant Prostate Cancer

(UroToday.com) The 2023 ESMO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Julie Graff discussing results of the phase 3 KEYNOTE-641 trial assessing pembrolizumab + enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC). Patients with mCRPC with progressive disease during second generation hormonal agent therapy…

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Final Multivariate Analysis from the Phase 3 MAGNITUDE

Niraparib and abiraterone acetate plus prednisone combination therapy also showed clinically relevant improvement versus standard of care in time to symptomatic progression and time to cytotoxic chemotherapy1 BEERSE, BELGIUM, Oct. 22, 2023 (GLOBE NEWSWIRE) — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the final analysis…

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Global Access Considerations in Systemic Treatment of Genitourinary Cancers

(UroToday.com) The 2023 European Society of Medical Oncology (ESMO) Annual Congress held in Madrid, Spain between October 20th and 24th, 2023 was host to a new diagnostic tools abstracts poster session. Dr. Xin Ye presented the results of a study evaluating a novel next generation sequencing (NGS) assay for the…

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Radiopharmaceuticals market booms with funding surge

Emerging as a new class of drugs, radiopharmaceuticals are all the rage in cancer treatment research, at present. And now, with American biotech Nucleus RadioPharma raising $56 million to streamline its supply chains and make the drugs more accessible, it seems like the radiopharmaceutical market might be onto something big….

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Promontory Therapeutics Presents Data on the Molecular Effects of PT-112 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

PT-112’s mechanism of action promotes immunogenic cancer cell death through ribosomal biogenesis inhibition and organelle stress NEW YORK, Oct. 14, 2023 /PRNewswire/ — Promontory Therapeutics Inc., a clinical stage biotech company advancing immunogenic small molecule approaches in oncology, today presented data on its lead therapeutic candidate PT-112, detailing its early…

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Metastatic Prostate Cancer Market Size in the 7MM was ~USD 6400 million in 2022, Estimates DelveInsight

PRESS RELEASE Published October 3, 2023 “The Metastatic Prostate Cancer market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period (2023-2032). Furthermore, launching various multiple- Metastatic Prostate Cancer pipeline products will significantly revolutionize the Metastatic Prostate Cancer market dynamics”   The Metastatic Prostate…

Continue Reading Metastatic Prostate Cancer Market Size in the 7MM was ~USD 6400 million in 2022, Estimates DelveInsight

Intrapatient Heterogeneity in Prostate Cancer: A Deep Dive into Androgen Receptor Alterations

Read the Full Video Transcript Andrea Miyahira: Hi everyone. Thanks for joining us today. I’m Andrea Miyahira, here with the Prostate Cancer Foundation. Today, I’m joined by Professor Gerhardt Attard of the University College London Cancer Institute, to discuss his group’s recent publication in Nature Communications, “Copy Number Architecture Defines…

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Recent research in prostate cancer: Breakthroughs and innovations

Prostate cancer is the second most commonly occurring cancer in men. More than 1.4 million people were diagnosed with prostate cancer in 2020, according to the World Cancer Research Fund International. While some prostate cancers develop too slowly, to the extent that some people will not need any treatment during…

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Exelixis and Ipsen Announce Positive Results from Phase 3

– Cabozantinib in combination with atezolizumab demonstrated a statistically significant reduction in the risk of disease progression or death compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer  – A trend toward improvement in overall survival was observed at first interim analysis  – Findings will…

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Impilo Therapeutics Bets on Stroma-Penetrating Platform to Bring Nucleic Acid Therapies to Cancer

NEW YORK – Nucleic acid-based therapies haven’t had much success treating cancer, but newly launched Impilo Therapeutics wants to change that. San Diego-based Impilo, which officially launched this week, aims to develop nucleic acid-based therapies against solid tumors, beginning with a treatment that targets androgen receptor splice variants in patients…

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2023-08-08 | NDAQ:ARVN | Press Release

– Enrollment continues globally in multiple clinical studies of vepdegestrant (ARV-471), including VERITAC-2 2L Phase 3 trial and study lead-in for the VERITAC-3 1L Phase 3 trial, both in ER+/HER2- metastatic breast cancer – – Interim data from Phase 1/2 dose escalation and expansion trial with ARV-766 shows promising signals…

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ctDNA and Lung Cancer | SpringerLink

Abbosh C, Birkbak NJ, Wilson GA, et al (2017) Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545:446–451. doi.org/10.1038/nature22364 CrossRef  CAS  PubMed  PubMed Central  Google Scholar  Adalsteinsson VA, Ha G, Freeman SS, et al (2017) Scalable whole-exome sequencing of cell-free DNA reveals high concordance with metastatic tumors. Nat Commun…

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FDA Drug Approvals April-June 2023

Oncology Columvi (glofitamab) Glofitamab is a bispecific CD3-directed and CD20-directed antibody that binds to CD20 expressed on the surface of B cells and to CD3 receptor expressed on the surface of T cells. It causes T-cell activation and proliferation, secretion of cytokines, and lysis of CD20-expressing B cells. Glofitamab is…

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Study Explores Role of Prostate Cancer Mutations in 3′ Untranslated Regions

NEW YORK— Researchers have unraveled the effects of mutations in the 3′ untranslated regions (UTR) of prostate cancer-related genes on disease progression, mRNA stability, and translation. In a study published in Cell Reports on Friday, the team, led by investigators at the Fred Hutchinson Cancer Center, studied somatic mutations in…

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The potential role of the microbiota in prostate cancer pathogenesis and treatment

Lynch, S. V. & Pedersen, O. The human intestinal microbiome in health and disease. N. Engl. J. Med. 375, 2369–2379 (2016). Article  CAS  PubMed  Google Scholar  Qin, J. et al. A human gut microbial gene catalogue established by metagenomic sequencing. Nature 464, 59–65 (2010). Article  CAS  PubMed  PubMed Central  Google…

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Crescendo Biologics raises $32M and expands cancer trial

Crescendo Biologics Ltd, a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, has announced that it plans to augment the ongoing phase 1b clinical trial of CB307 through the addition of a new pembrolizumab (anti-PD-1) combination expansion cohort.  Additional financing of $32 million has been secured with…

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Rini Expands on Key Clinical Trial Updates in GU Cancers from the 2023 ASCO Annual Meeting

Although the phase 3 CONTACT-03 trial (NCT04338269) evaluating atezolizumab (Tecentriq) plus cabozantinib (Cabometyx) compared with cabozantinib in patients with advanced renal cell carcinoma (RCC) who received a prior immune checkpoint inhibitor proved to be a negative study, the findings provided crucial information regarding immunotherapy rechallenge in this patient population, according…

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PARP inhibitors: enhancing efficacy through rational combinations

Bai P. Biology of poly(ADP-Ribose) polymerases: the factotums of cell maintenance. Mol Cell. 2015;58:947–58. Article  CAS  PubMed  Google Scholar  Ray U, Raghavan SC. Understanding the DNA double-strand break repair and its therapeutic implications. DNA Repair. 2021;106:103177. Article  CAS  PubMed  Google Scholar  Wright WD, Shah SS, Heyer WD. Homologous recombination and…

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Dr Agarwal on Advances With PARP Inhibitors in Prostate Cancer

Neeraj Agarwal, MD, professor, medicine, Presidential Endowed Chair, Cancer Research, director, Genitourinary Oncology Program, director, Center of Investigational Therapeutics, Huntsman Cancer Institute, University of Utah, discusses the role of PARP inhibitors in metastatic castration-resistant prostate cancer (mCRPC) and the potential evolutions of the mCRPC and metastatic castration-sensitive prostate cancer (mCSPC) treatment paradigms….

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Niraparib Improves rPFS in Patients With mCRPC and HRR Alterations

Niraparib can improve upon first-line treatment with abiraterone acetate and prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations, a phase 3 trial suggests. Researchers found that niraparib plus AAP prolonged radiographic progression-free survival (rPFS) when compared with AAP alone in patients…

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ASCO 2023: Improving Genitourinary Cancer Care

New findings from phase 3 trials presented at the ASCO Annual Meeting 2023 have the potential to influence the clinical management of genitourinary cancers and perhaps establish new standards of care. Results from the VESPER trial showed that dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) prolongs overall survival (OS) when…

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FibroGen Announces Topline Results from Phase 3 ZEPHYRUS-1 Study of Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis

–  Study did not meet the primary endpoint –  Pamrevlumab was generally safe and well tolerated –  ZEPHYRUS-2 Phase 3 study will be discontinued –  Company to implement plan to extend cash runway into 2026 SAN FRANCISCO, June 26, 2023 (GLOBE NEWSWIRE) — FibroGen, Inc., Inc. (NASDAQ: FGEN) today announced topline results from…

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FibroGen Phase 3 ZEPHYRUS-1 Study of Pamrevlumab for Treatment of Idiopathic Pulmonary Fibrosis Did Not Meet Primary Endpoint By Investing.com

FibroGen, Inc. (FGEN) today announced topline results from its Phase 3 ZEPHYRUS-1 trial evaluating the safety and efficacy of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). The study compared treatment with pamrevlumab to placebo and did not meet the primary endpoint of change from baseline in forced vital capacity…

Continue Reading FibroGen Phase 3 ZEPHYRUS-1 Study of Pamrevlumab for Treatment of Idiopathic Pulmonary Fibrosis Did Not Meet Primary Endpoint By Investing.com

FibroGen Announces Topline Results from Phase 3 ZEPHYRUS-1

–  Study did not meet the primary endpoint–  Pamrevlumab was generally safe and well tolerated–  ZEPHYRUS-2 Phase 3 study will be discontinued–  Company to implement plan to extend cash runway into 2026 SAN FRANCISCO, June 26, 2023 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) today announced topline results from its Phase 3 ZEPHYRUS-1…

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FDA Approves Talazoparib In Combination With Enzalutamide for mCRPC

The FDA has approved talazoparib (Talzenna) in combination with enzalutamide (Xtandi) for the treatment of adult patients with homologous recombination repair (HRR)-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval is based on data from the phase 3 TALAPRO-2 trial (NCT03395197).1,2 The median radiographic progression-free survival (rPFS) with talazoparib/enzalutamide was not…

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Physicians Discuss the Addition of Cabizatxel to Treatment in mCRPC

CASE SUMMARY A 75-year-old man presented with intermittent left hip pain and his physical exam was unremarkable expect for a prostate nodule on a rectal exam. The patient had an ECOG performance score of 1 and a prostate-specific antigen (PSA) of 16.2 ng/mL with a transrectal ultrasound scan (TRUS) and…

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FDA Updates for the Week of June 5, 2023

FDA Approves Novel Cyclosporine for Dye Eye Disease The FDA has approved Novaliq’s Vevye (cyclosporine) 0.1% to treat patients with dry eye disease. Vevye (which had development name CyclASol) is a water-free, preservative-free solution based on EyeSol technology. Cyclosporine is not water-soluble, but the EyeSol excipient perfluorobutylpentane allows for improved bioavailability…

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Talazoparib Plus Enzalutamide Shows Potential for New SOC in HRR mCRPC

The combination of talazoparib (Talzenna) and standard of care enzalutamide (Xtandi) showed statistically significant and clinically meaning progression free survival (PFS) improvement as a first-line therapy for patients with metastatic castration-resistant prostate cancer (mCRPC) that have homologous recombination repair (HRR) gene alterations in their disease, according to new data presented…

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Talazoparib Plus Enzalutamide Manageable With Dose Modification Strategy in mCRCPC

Arun Azad, MBBS, PhD, FRACP In patients with metastatic castration-resistant prostate cancer (mCRPC) treated in the phase 3 TALAPRO-2 study (NCT03395197), the combination of talazoparib plus enzalutamide (Xtandi) appeared to be manageable with dose modifications or supportive care, according to a 2023 ASCO Annual Meeting presentation.1 “TALAPRO-2 is the first…

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Talazoparib/enzalutamide combo shows manageable safety profile in mCRPC

Combination talazoparib plus enzalutamide was found to be generally manageable with dose modifications or standard supportive care in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC), according to safety results from the phase 3 TALAPRO-2 study (NCT03395197).1 Patients in the phase 3 TALAPRO-2 study were randomized 1:1 to…

Continue Reading Talazoparib/enzalutamide combo shows manageable safety profile in mCRPC

FDA Approves Olaparib Triplet for mCRPC

Data from the phase 3 PROpel study support the FDA approval of olaparib combined with abiraterone and prednisone or prednisolone. This approval is indicated for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). The recommended olaparib dose is 300 mg taken orally twice daily…

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Unveiling the Role of Rb Gene in Prostate Cancer: BET Inhibitors and Immunotherapy

Read the Full Video Transcript Andrea Miyahira: Hi, everyone. I’m Andrea Miyahira and I’m the senior director of global research and scientific communications at PCF. Today I’m joined by Dr. Akash Patnaik, an assistant professor at the University of Chicago Comprehensive Cancer Center. Dr. Patnaik is joining me today to…

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CYCLONE 1 Misses Primary End Point But Abemaciclib Shows Activity in mCRPC

Abemaciclib Shows Activity in mCRPC: © SciePro – stock.adobe.com Although the phase 2 CYCLONE 1 trial (NCT04408924) did not meet its primary end point of overall response rate (ORR), treatment with abemaciclib (Verzenio) did demonstrate clinical activity among patients withmetastatic castration-resistant prostate cancer (mCRPC), according to findings presented during the…

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Dr. Carducci on the Ongoing CAPItello-280 Trial in mCRPC

Michael A. Carducci, MD, professor of oncology, AEGON Professor of Prostate Cancer Research, Johns Hopkins Medicine, discusses the significance of two ongoing clinical trials in prostate cancer: the phase 3 CAPItello-280 trial (NCT05348577) and phase 3 INDICATE study (EA8191; NCT04423211). The randomized CAPItello-280 trial was designed to build on preclinical…

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ADC Therapeutics : Annual Report – Form 6-K

ADC Therapeutics SA 2022 Annual Report Table of Contents Letter to Shareholders Business Update Financial Review Corporate Governance Report from the Auditor on the Consolidated IFRS Financial Statements Consolidated IFRS Financial Statements for the Year Ended December 31, 2022 Report from the Auditor on the Statutory Financial Statements of ADC…

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Expert Charts the Changing Treatment Landscape in CRPC

Matthew Dallos, MD, established therapies that are beginning to move into earlier lines of treatment, emerging antibody-drug conjugates (ADCs), and the potential of third generation anti-androgen agents in advanced castration-resistant prostate cancer (CRPC) in a presentation during the 16th Annual Interdisciplinary Prostate Cancer Congress® and Other Genitourinary Malignancies, hosted by…

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Analyzing Poseida Therapeutics (NASDAQ:PSTX) & CRISPR Therapeutics (NASDAQ:CRSP)

Poseida Therapeutics (NASDAQ:PSTX – Get Rating) and CRISPR Therapeutics (NASDAQ:CRSP – Get Rating) are both medical companies, but which is the superior stock? We will contrast the two businesses based on the strength of their institutional ownership, earnings, risk, analyst recommendations, profitability, dividends and valuation. Earnings and Valuation This table…

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Dr. Zhang on Key Phase 3 Trials for PARP Inhibitors in mCRPC

Tian Zhang, MD, MHS, associate professor, the Department of Internal Medicine, Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, discusses key phase 3 trials evaluating PARP inhibitors in the treatment of metastatic castration-resistance prostate cancer (mCRPC). The phase 3 trials that have examined PARP inhibitor monotherapy include the…

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POINT Biopharma Confirms No Disruptions to the Manufacturing and Clinical Supply for the 177Lu-PNT2002 SPLASH Trial, a Phase 3 Study in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

INDIANAPOLIS, March 07, 2023 (GLOBE NEWSWIRE) — POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today affirmed that the SPLASH clinical trial for the PSMA-targeted PNT2002 program is not experiencing any manufacturing or drug supply issues…

Continue Reading POINT Biopharma Confirms No Disruptions to the Manufacturing and Clinical Supply for the 177Lu-PNT2002 SPLASH Trial, a Phase 3 Study in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC)

BRIEF-Point Biopharma Confirms No Disruptions To The Manufacturing And Clinical Supply For The 177Lu-Pnt2002 Splash Trial, A Phase 3 Study In Patients With Metastatic Castration Resistant Prostate Cancer (Mcrpc)

* POINT BIOPHARMA CONFIRMS NO DISRUPTIONS TO THE MANUFACTURING AND CLINICAL SUPPLY FOR THE 177LU-PNT2002 SPLASH TRIAL, A PHASE 3 STUDY IN PATIENTS WITH METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MCRPC) * POINT BIOPHARMA GLOBAL- SPLASH CLINICAL TRIAL FOR PSMA-TARGETED PNT2002 PROGRAM IS NOT EXPERIENCING ANY MANUFACTURING OR DRUG SUPPLY ISSUES…

Continue Reading BRIEF-Point Biopharma Confirms No Disruptions To The Manufacturing And Clinical Supply For The 177Lu-Pnt2002 Splash Trial, A Phase 3 Study In Patients With Metastatic Castration Resistant Prostate Cancer (Mcrpc)

POINT Biopharma Confirms No Disruptions to Manufacturing, Clinical Supply for 177Lu-PNT2002 SPLASH Trial, a Phase 3 Study in Patients with mCRPC

POINT Biopharma Global Inc. (PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today affirmed that the SPLASH clinical trial for the PSMA-targeted PNT2002 program is not experiencing any manufacturing or drug supply issues or delays. “POINT’s first investments were into supply…

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Two Phase 3 Pembrolizumab Trials Show Lack of Benefit in Prostate/Lung Cancer

Two phase 3 trials assessing the benefit of pembrolizumab (Keytruda) combination therapies in metastatic castration-resistant prostate cancer (mCRPC) and metastatic non-squamous non–small cell lung cancer (NSCLC) demonstrated a lack of efficacy, according to a press release published by Merck. The safety profile of pembrolizumab in KEYNOTE-641 and KEYNOTE-789 was consistent…

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Pembrolizumab Misses Mark in mCRPC, EGFR-Mutant NSCLC Trials

Pembrolizumab missed its primary radiographic progression-free survival (rPFS) and overall survival (OS) end points when added to enzalutamide (Xtandi) and androgen deprivation therapy (ADT) and assessed in patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 KEYNOTE-641 trial (NCT03834493). Similarly, in the phase 3 KEYNOTE-789 trial (NCT03515837), the addition…

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Final Overall Survival Results from the PROpel Phase 3 Trial in First-line Therapy for mCRPC

Read the Full Video Transcript Alicia Morgans: Hi, I’m so excited to be here with Professor Fred Saad to talk about the updated PROpel data that was presented at GU ASCO 2023. Thank you so much for being here. Fred Saad: Always a pleasure. Alicia Morgans: It’s always a pleasure…

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Pembrolizumab Misses Survival End Points in mCRPC/NSCLC

Data from 2 phase 3 studies evaluating pembrolizumab, KEYNOTE-641 (NCT03834493) and KEYNOTE-789 (NCT03515837) failed to meet their primary end points, according to Merck.1 As a result, the KEYNOTE-641 trial will be discontinued based on the recommendation of an independent Data Monitoring Committee. The KEYNOTE-789 trial will continue.1 The phase 3…

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Merck Provides Update on Phase 3 Trials KEYNOTE-641 and KEYNOTE-789

February 28, 2023 6:45 am ET RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-641 and KEYNOTE-789. Merck is discontinuing the Phase 3 KEYNOTE-641 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with…

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Delivering on the promise of protein degraders

Hopkins, A. L. & Groom, C. R. The druggable genome. Nat. Rev. Drug Discov. 1, 727–730 (2002). Article  CAS  PubMed  Google Scholar  Uhlén, M. et al. Tissue-based map of the human proteome. Science 347, 1260419 (2015). Article  PubMed  Google Scholar  Churcher, I. Protac-induced protein degradation in drug discovery: breaking the…

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Machine-Learning to Predict Utility of Circulating Tumor DNA (ctDNA) for Somatic Genotyping

(Urotoday.com) On the first day of the American Society for Clinical Oncology (ASCO) Genitourinary Cancer Symposium 2023 focussing on prostate cancer, Dr. Cameron Herberts presented in Poster Session A on a machine-learning approach to predict the utility of circulating tumor DNA for somatic genotyping in advanced prostate cancer. Increasingly, ctDNA genotyping…

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Rucaparib Improves rPFS vs Physician’s Choice as Treatment for BRCA+ mCRPC

In the phase 3 TRITON3 study (NCT02975934), treatment with rucaparib (Rubraca) led to improved median radiographic progression-free survival (rPFS) by 4.8 months vs physician’s choice of therapy for men with BRCA-altered metastatic castration-resistant prostate cancer (mCRPC), according to findings presented at the 2023 Genitourinary Cancers Symposium and simultaneously published in…

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Pfizer’s Talzenna combination shows promise in phase 3 prostate cancer study

Pfizer has announced positive results from a phase 3 study of its PARP inhibitor Talzenna (talazoparib) in combination with Astellas-partnered androgen inhibitor Xtandi (enzalutamide) in metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a cancer that has spread beyond the prostate gland and has progressed despite medical or surgical treatment to…

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Pfizer Announces Positive TALZENNA and XTANDI Combination Data from Phase 3 TALAPRO-2 Study

NEW YORK – Pfizer (NYSE: PFE) announced today positive results from the Phase 3 TALAPRO-2 study of TALZENNA (talazoparib), an oral poly ADP-ribose polymerase inhibitor, in combination with XTANDI, demonstrating a statistically significant and clinically meaningful improvement in radiographic progression-free survival compared to placebo plus XTANDI in men with metastatic…

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PROpel Study of Abiraterone/Olaparib Sustains Benefit in mCRPC

Noel W. Clarke, MBBS, FRCS, ChM Abiraterone acetate (Zytiga) combined with olaparib (Lynparza) maintained a trend toward improved efficacy compared with the standard-of-care of abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC), according to findings from the final prespecified overall survival (OS) analysis of PROpel (NCT03732820).1 At the final…

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Randomized, Double-Blind, Phase 3 KEYNOTE-921 Study

(UroToday.com) The 2023 GU ASCO annual meeting included a session on prostate cancer, featuring a presentation by Dr. Daniel Petrylak discussing results from KEYNOTE-921, a randomized, double-blind, phase 3 study of pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC). Docetaxel is a treatment option following disease progression on…

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Circulating Tumor DNA Identifies Homologous Recombination Deficiency in Bone-Predominant mCRPC Prior to Radium-223 Therapy

(UroToday.com) Radium-223 is an FDA approved therapy for metastatic castration resistant prostate cancer (mCRPC). Its mechanism of action relies on its intrinsic radioactivity and its similarity to calcium, allowing for uptake into bones in mCRPC and delivery of alpha particles with the energy to induce double-stranded DNA breaks. As anticipate,…

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Metastatic Prostate Cancer Clues Found with Liquid Biopsy Approach

For a paper in Clinical Chemistry, a team from Denmark, Sweden, and Belgium describe survival insights that can be gained through low-coverage sequencing of circulating tumor DNA (ctDNA) in individuals with metastatic, castration-resistant prostate cancer (mCRPC). The investigators used their low-pass whole-genome sequencing (LPWGS) approach to assess cell-free DNA (cfDNA)…

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Bayesian machine learning enables identification of transcriptional network disruptions associated with drug-resistant prostate cancer | Cancer Research

Survival rates of patients with metastatic castration-resistant prostate cancer (mCRPC) are low due to lack of response or acquired resistance to available therapies, such as abiraterone (Abi). A better understanding of the underlying molecular mechanisms is needed to identify effective targets to overcome resistance. Given the complexity of the transcriptional…

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Plasma Extracellular Vesicle circRNA Signature and Resistance to Abiraterone in Metastatic Castration-Resistant Prostate Cancer

582 mCRPC patients undergoing first-line abiraterone therapy from four institutions were sorted by three phases: discovery, training, and validation. [British Journal of Cancer] Read more here: Source link

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AstraZeneca and Merck – Results From Phase 3 PROpel Trial of LYNPARZA (olaparib) Plus Abiraterone in First-Line Metastatic Castration-Resistant Prostate Cancer Published in NEJM Evidence

RAHWAY, N.J. – AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the results from the Phase 3 PROpel trial have been published in NEJM Evidence. Results from the trial showed that LYNPARZA in combination with abiraterone plus prednisone significantly improved radiographic progression-free…

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Integration of Liquid Biopsies in Clinical Management of Metastatic Prostate Cancer

This article was originally published here Curr Oncol Rep. 2022 May 16. doi: 10.1007/s11912-022-01278-0. Online ahead of print. ABSTRACT PURPOSE OF REVIEW: The field of liquid biopsies is constantly evolving through novel technologies. This review outlines current data on liquid biopsies and application to clinical management of metastatic prostate cancer….

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New publication in European Urology demonstrates value of PredicineCARE liquid biopsy test for monitoring PD-L1 immunotherapy in patients with metastatic prostate cancer | News

HAYWARD, Calif., Sept. 16, 2021 /PRNewswire-PRWeb/ — Predicine, Inc. announced today results from a liquid biopsy study demonstrating the clinical application of utilizing the PredicineCARE liquid biopsy NGS assay to serially monitor changes in ctDNA levels in patients with metastatic castration-resistant prostate cancer (mCRPC). The European Urology study evaluated the effects…

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Analysis of the Prognostic Significance of Circulating Tumor DNA in Metastatic Castrate Resistant Prostate Cancer

This article was originally published here Clin Genitourin Cancer. 2021 Jul 31:S1558-7673(21)00151-8. doi: 10.1016/j.clgc.2021.07.012. Online ahead of print. ABSTRACT BACKGROUND: There has been considerable interest in ctDNA next generation sequencing platforms to assess genomic alterations in mCRPC given its accessibility and identification of temporal genomic data. PATIENTSAND METHODS: In this…

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