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Clinical Trial News

Major Kinase Inhibitor Summit to Showcase Next-Generation Cancer Therapeutics Advances

  • Leading pharmaceutical companies including Pfizer, MEI Pharma, and Onconova Therapeutics will present breakthrough developments in kinase inhibitor research at the upcoming Boston summit in February 2023.
  • MEI Pharma's Voruciclib shows promising results in downregulating MYC and MCL1, demonstrating potential therapeutic applications across hematological and solid tumors.
  • The summit will address critical challenges in kinase inhibitor development, including enhanced specificity, resistance mechanisms, and improved safety profiles for better clinical outcomes.

Real-world Evaluation of Ocrelizumab in Multiple Sclerosis Shows Promising Results

A comprehensive review of 52 studies on ocrelizumab's effectiveness in treating multiple sclerosis (MS) reveals promising real-world outcomes, including low relapse rates, significant reductions in annualized relapse rates (ARR), and improvements in magnetic resonance imaging (MRI) activity. The studies, spanning various geographical regions, indicate that ocrelizumab is effective across diverse patient populations, with outcomes consistent with those reported in pivotal clinical trials.

GSK's Jesduvroq Receives FDA Approval for Anemia in Dialysis-Dependent CKD Patients

  • The FDA has approved GSK's Jesduvroq (roxadustat) for anemia treatment in adults with chronic kidney disease (CKD) who are on dialysis.
  • This approval is limited to dialysis-dependent patients, impacting the drug's market potential compared to a broader CKD indication.
  • Jesduvroq represents a new oral treatment option for anemia in this patient population, addressing an unmet need in managing CKD-related complications.
  • GSK's shares experienced a slight increase following the FDA's announcement, reflecting investor response to the regulatory decision.

Rise Therapeutics' Oral Immunotherapy R-3750 Receives FDA Clearance for Phase 1 Ulcerative Colitis Trial

  • Rise Therapeutics received FDA clearance for its IND application to begin a Phase 1 trial of R-3750, an oral immunotherapy, for ulcerative colitis.
  • R-3750 leverages synthetic biology to deliver a microbiome-associated immune regulatory molecule, targeting the immunological basis of gastrointestinal inflammation.
  • The Phase 1 study will assess the safety, tolerability, drug exposure, and clinical activity of R-3750 in mild to moderate ulcerative colitis patients.
  • The trial will enroll up to 36 participants, with clinical activity measured by improvements in disease severity and key biomarker assessments.

Real-World Study Affirms Palbociclib's Efficacy in Chinese HR+/HER2- Metastatic Breast Cancer Patients

• A real-world study in Northwest China confirms Palbociclib plus endocrine therapy (ET) benefits HR+/HER2- metastatic breast cancer (MBC) patients, aligning with global findings. • The study highlights that earlier initiation of Palbociclib shows better outcomes, with median PFS of 14.2 months in the first-line setting. • Poorer prognosis was observed in patients with prior chemotherapy, low progesterone receptor (PgR) expression, and more than three metastatic sites. • The research suggests Palbociclib-based therapy is a viable option for MBC patients in China, even in later lines of therapy, despite economic and healthcare system limitations.

FDA Approves Elacestrant as First Oral SERD for Advanced ER+/HER2- Breast Cancer

Drug Approval
  • The FDA has approved elacestrant (Orserdu), marking the first oral selective estrogen receptor degrader (SERD) to demonstrate improved efficacy over standard of care treatments in advanced breast cancer.
  • In the phase 3 EMERALD trial, elacestrant reduced the risk of progression or death by 30% in all patients and by 45% in patients with ESR1 mutations compared to standard endocrine therapy.
  • The approval provides a new oral treatment option for patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer following prior endocrine therapy including CDK4/6 inhibitors.
  • Elacestrant showed manageable safety profile with nausea being the most common adverse event, occurring in 35% of patients in the treatment arm.

A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)

NCT04576455Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 11/27/2020

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

NCT04975308Active, Not RecruitingPhase 3
Eli Lilly and Company
Posted 10/4/2021

Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer

NCT03778931CompletedPhase 3
Stemline Therapeutics, Inc.
Posted 5/10/2019

Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer

NCT04059484TerminatedPhase 2
Sanofi
Posted 10/22/2019

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

NCT05596409Active, Not RecruitingPhase 2
Stemline Therapeutics, Inc.
Posted 5/19/2023

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

NCT05563220RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 1/24/2023

A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer

NCT04214288Active, Not RecruitingPhase 2
AstraZeneca
Posted 4/22/2020

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to ER+/HER-2- Breast Cancer

NCT05386108RecruitingPhase 1
Stemline Therapeutics, Inc.
Posted 8/31/2022

Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer

NCT02632045CompletedPhase 2
Melissa K Accordino
Posted 3/1/2016

European Medicines Agency Accepts Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease

The European Medicines Agency has accepted a marketing authorization application for lecanemab, a treatment for early Alzheimer’s disease. Lecanemab, developed through a strategic research alliance between BioArctic and Eisai, has shown potential in slowing disease progression by targeting amyloid-beta protofibrils. The treatment has received accelerated approval in the U.S. and is under review in Japan and China.

FDA Grants Priority Review to Sunvozertinib for EGFR Exon 20 Insertion-Mutated NSCLC

  • The FDA granted priority review to sunvozertinib for treating advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
  • This decision was based on efficacy and safety data from the WU-KONG1 trial, which demonstrated promising results.
  • Abenacianine, a tumor-targeted fluorescent imaging agent, received fast track designation for visualizing lung tumors, based on phase 2 study results.

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