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Clinical Trial News

J&J Highlights Solid Tumor Advances at WCLC and ESMO 2024

  • Johnson & Johnson is set to present 11 oral presentations at WCLC and ESMO 2024, showcasing advancements in solid tumor treatments for lung, bladder, prostate, and colorectal cancers.
  • Phase 3 MARIPOSA study data will highlight RYBREVANT® plus LAZCLUZE™ as a first-line treatment for EGFR-mutated advanced NSCLC, demonstrating improved overall survival compared to osimertinib.
  • New data from the SunRISe program will reveal the potential of TAR-200 as an organ-sparing therapy for bladder cancer, offering a novel targeted drug-releasing system.
  • The OrigAMI-1 study will present initial results of RYBREVANT® plus chemotherapy in metastatic colorectal cancer, addressing the urgent need for more durable therapies.

FDA Updates Pemgarda EUA Due to Emerging SARS-CoV-2 Variants

  • The FDA has revised the Emergency Use Authorization for Pemgarda, limiting its use to situations where variants with reduced susceptibility are 90% or less of circulating strains.
  • This decision follows data indicating some SARS-CoV-2 variants, like KP.3.1.1, may exhibit substantially reduced susceptibility to Pemgarda.
  • Healthcare providers are advised to monitor for COVID-19 symptoms in Pemgarda recipients and promptly initiate alternative treatments if infection occurs.
  • Alternative treatments like Paxlovid, Veklury and Lagevrio are expected to remain effective against current variants for high-risk patients.

Extended Neoadjuvant Chemoradiation Increases Rectal Cancer Remission Rates, Reducing Need for Surgery

  • A Swedish study reveals that administering chemotherapy and radiation before surgery significantly increases the likelihood of rectal tumor remission.
  • The approach led to a 28% tumor disappearance rate, doubling the 14% rate seen with traditional methods, potentially eliminating the need for rectal removal.
  • Preserving the rectum through this method improves patients' quality of life by avoiding colostomy and maintaining normal bowel function.
  • The extended neoadjuvant chemoradiation did not increase local tumor recurrence rates after nearly five years of follow-up.

Cholinesterase Inhibitors Show Promise in Slowing Lewy Body Dementia Progression

  • Cholinesterase inhibitors (ChEIs) like donepezil, rivastigmine, and galantamine, typically used for Alzheimer's, may slow cognitive decline in Lewy body dementia.
  • A study of nearly 1,100 patients indicated that ChEIs significantly slowed cognitive decline compared to memantine or no treatment over a five-year period.
  • Galantamine and donepezil showed particular promise in arresting the progression of Lewy body dementia symptoms, offering potential symptom relief.
  • ChEIs were associated with a 34% lower risk of death within the first year of Lewy body dementia diagnosis, suggesting a potential survival benefit.

McKesson Acquires $2.49 Billion Controlling Stake in Florida Cancer Specialists to Expand Community Oncology Platform

  • McKesson Corporation agreed to purchase a 70% controlling stake in Florida Cancer Specialists' Core Ventures for approximately $2.49 billion in cash to strengthen its oncology platform.
  • The acquisition brings Florida Cancer Specialists, with over 250 physicians and 280 advanced practice providers across nearly 100 Florida locations, into McKesson's US Oncology Network.
  • The transaction aims to advance community-based cancer care by combining operational expertise to increase access to high-quality, affordable oncology services and treatments.
  • Florida Cancer Specialists will maintain independent ownership while gaining access to McKesson's differentiated oncology care products, services, and clinical trial capabilities through Sarah Cannon Research Institute.
Oncology

European Commission Approves Celltrion's SteQeyma Biosimilar for Inflammatory Diseases

  • The European Commission (EC) has approved Celltrion's SteQeyma, a biosimilar of Stelara (ustekinumab), for treating multiple chronic inflammatory diseases.
  • SteQeyma is approved across gastroenterology, dermatology, and rheumatology indications, offering a new biologic therapy option for patients.
  • The approval is based on comprehensive clinical data, including a Phase III trial demonstrating similarity in efficacy and safety to Stelara in treating plaque psoriasis.
  • Celltrion aims to strengthen its immunology portfolio and expand patient access to affordable, high-quality biologic medicines with this approval.

SI-BONE's iFuse TORQ TNT Implant System Receives FDA Clearance for Pelvic Fragility Fractures

  • SI-BONE's iFuse TORQ TNT implant system has received FDA 510(k) clearance, offering a novel solution for pelvic fragility fractures.
  • The TNT system is designed to address the specific anatomical and bone mineral density needs of the sacrum and ilium, potentially improving treatment outcomes.
  • TNT's design aims to enhance early fixation and reduce screw backout, facilitating earlier patient weight-bearing and mobilization post-surgery.
  • The sacroiliac joint fusion market is projected to grow significantly, with SI-BONE's advancement positioning it well to address unmet clinical needs.

FDA Grants Priority Review for Setmelanotide sNDA in Young Children with Rare Genetic Obesity

  • The FDA has accepted Rhythm Pharmaceuticals' sNDA for setmelanotide, seeking approval for children aged 2-6 with obesity due to Bardet-Biedl syndrome or POMC/LEPR deficiency.
  • The sNDA is supported by Phase 3 trial data showing a 3.04 mean reduction in BMI-Z score and an 18.4% mean reduction in BMI with setmelanotide treatment.
  • The FDA has granted Priority Review with a PDUFA goal date of December 26, 2024, potentially offering a precision therapy for young patients with rare MC4R pathway diseases.
  • Setmelanotide is currently approved for patients 6 years and older with specific genetic obesity conditions, and this expansion could positively affect younger children and their families.

Xaluritamig: A Promising New Therapeutic for Metastatic Castration-Resistant Prostate Cancer

Xaluritamig, a novel T-cell redirecting therapy targeting STEAP1, shows encouraging efficacy and safety in treating metastatic castration-resistant prostate cancer (mCRPC), offering new hope for patients with this challenging condition.

A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors

NCT03972657RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 8/12/2019

Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

NCT06236139RecruitingPhase 1
Fred Hutchinson Cancer Center
Posted 11/26/2024

Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT04221542RecruitingPhase 1
Amgen
Posted 3/4/2020

A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy

NCT06085664RecruitingPhase 1
M.D. Anderson Cancer Center
Posted 12/4/2023

Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors

NCT05585034Active, Not RecruitingPhase 1
Xencor, Inc.
Posted 12/14/2022

A Study of JNJ-87189401 Plus JNJ-78278343 for Advanced Prostate Cancer

NCT06095089RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/1/2023

Izotropic Plans Regulatory Approval for IzoView Breast CT in U.S. and EU

Izotropic Corporation is advancing its regulatory strategy to launch IzoView, a breast CT imaging system, in the U.S. and EU. The device is aimed at diagnosing breast cancer in patients with dense breast tissue, utilizing a clinical study to prove its efficacy alongside digital breast tomosynthesis.
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