Tag: mCRPC

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…

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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…

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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…

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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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