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Clinical Trial News

Pembrolizumab Plus Chemoradiotherapy Improves PFS in East Asian Cervical Cancer Patients

  • In East Asian patients with high-risk, locally advanced cervical cancer, pembrolizumab plus concurrent chemoradiotherapy (CCRT) significantly improved progression-free survival (PFS).
  • At 24 months, the PFS rate in the pembrolizumab plus CCRT arm was 77.6% compared to 59.8% in the placebo plus CCRT arm, demonstrating a substantial difference.
  • The safety profile of pembrolizumab plus CCRT in the East Asian subgroup was manageable and consistent with the overall study population, supporting its potential use.
  • These findings suggest pembrolizumab plus CCRT could be a new treatment option for this patient population, particularly relevant given the high incidence of cervical cancer in East Asia.

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

NCT04221945Active, Not RecruitingPhase 3
Merck Sharp & Dohme LLC
Posted 5/12/2020

FDA Advisory Committee to Review Elamipretide for Barth Syndrome

  • The FDA's Cardiovascular and Renal Drugs Advisory Committee will review elamipretide for Barth syndrome on October 10, 2024.
  • Elamipretide, a first-in-class mitochondria-targeted therapeutic, is under review as a potential treatment for this ultra-rare genetic condition.
  • The FDA has granted priority review to the NDA for elamipretide, with a PDUFA action date set for January 29, 2025.
  • Barth syndrome affects approximately 150 individuals in the U.S. and is associated with reduced life expectancy, with no current FDA-approved therapies.

BAY 2927088 Demonstrates Promising Activity in HER2-Mutant NSCLC

• BAY 2927088, a novel oral TKI, showed a 72.1% objective response rate in pretreated HER2-mutant NSCLC patients in the SOHO-01 trial. • The disease control rate with BAY 2927088 was 83.7%, with a median duration of response of 8.7 months and progression-free survival of 7.5 months. • A subgroup analysis revealed a 90% objective response rate in patients with YVMA insertion mutations, a common and difficult-to-treat HER2 mutation. • The most common treatment-related adverse event was diarrhea, with a low discontinuation rate of 6.8% observed in the study cohort.

A Study to Learn More About How Well Sevabertinib (BAY 2927088) Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

NCT06452277RecruitingPhase 3
Bayer
Posted 8/28/2024

First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2)

NCT05099172Active, Not RecruitingPhase 1
Bayer
Posted 10/25/2021

Servier and Clariness Collaborate on Phase II Trial for Sjögren's Syndrome Drug

  • Servier and Clariness are collaborating on a Phase II trial to develop a novel biological therapy for primary Sjögren's syndrome, an autoimmune disease affecting salivary and lacrimal glands.
  • The investigational drug uses an antibody to suppress inflammatory processes associated with Sjögren's syndrome, addressing the unmet need for targeted treatments.
  • Clariness is supporting Servier's digital patient recruitment efforts in Germany through the ClinLife portal to accelerate enrollment in the Phase II study.
  • Current treatments for Sjögren's syndrome primarily focus on symptomatic relief, highlighting the potential impact of a targeted therapy under development.

Semaglutide Linked to Reduced COVID-19 and Cardiovascular Deaths in SELECT Trial

  • Semaglutide significantly reduced overall mortality by 19% in overweight or obese patients with heart disease compared to placebo.
  • Cardiovascular deaths were 15% lower in the semaglutide group, highlighting the drug's potential cardioprotective effects.
  • The study surprisingly found a 23% reduction in deaths from non-cardiovascular causes, including COVID-19-related deaths, with semaglutide.
  • Further research is needed to understand the mechanisms behind semaglutide's benefits beyond weight loss, especially regarding infection-related mortality.

Agenus Faces Class Action Lawsuit Over Botensilimab and Balstilimab Claims

  • Agenus Inc. is facing a class action lawsuit on behalf of investors who purchased securities between January 23, 2023, and July 17, 2024.
  • The lawsuit alleges that Agenus made misleading statements about the effectiveness of botensilimab and balstilimab combination therapy.
  • The FDA's feedback against using trial results for accelerated approval of the combination therapy in colorectal cancer led to a significant stock drop.
  • Investors have until November 5, 2024, to file a lead plaintiff motion in the class action lawsuit.

Olezarsen Shows Promise in Reducing High Triglycerides in New Study

  • A recent study reveals that olezarsen, an investigational drug, significantly reduces triglyceride levels by up to 50% in patients with hypertriglyceridemia.
  • The research indicates that olezarsen not only lowers triglycerides but also reduces other key indicators of cardiovascular risk, offering a potential new treatment avenue.
  • Current treatment options for high triglycerides are limited, making olezarsen a promising candidate for addressing this unmet medical need and preventing severe complications.
  • Olezarsen's efficacy could provide a substantial improvement over existing medications, which have a limited impact on lowering triglyceride levels effectively.

Psilera's PSIL-006 Shows Promise in Treating Frontotemporal Dementia Without Hallucinogenic Effects

  • Psilera's PSIL-006, a psilocybin-based drug, has demonstrated a strong safety profile in preclinical studies, marking a key milestone in dementia treatment.
  • The drug is designed to avoid inducing hallucinogenic effects, potentially enabling more reliable double-blind trials and safer administration for patients.
  • PSIL-006 has shown promising improvements in memory, sleep, and learning in models mimicking frontotemporal dementia (FTD), which currently lacks FDA-approved treatments.
  • The development of non-psychedelic therapies like PSIL-006 could significantly impact mental health and dementia care, offering more accessible treatment options.

Novel Therapies and Treatment Strategies Highlighted for Non-Small Cell Lung Cancer at WCLC 2024

• Perioperative durvalumab plus chemotherapy demonstrates improved event-free survival and pathological complete response in resectable NSCLC, establishing a new standard of care. • BAY 2927088, an oral tyrosine kinase inhibitor, shows a 72.1% objective response rate in pretreated patients with advanced HER2-mutant NSCLC. • Firmonertinib, a brain-penetrant EGFR inhibitor, exhibits an 81.9% overall response rate in NSCLC patients with EGFR PACC mutations, including those with brain metastases.

Master Protocol Trials Emerge as Efficient Framework for Precision Oncology

  • Master protocol trials, including basket, umbrella, and platform designs, are streamlining cancer research by evaluating multiple hypotheses simultaneously.
  • Basket trials assess the same treatment across various diseases or subtypes, particularly in oncology, based on shared biomarkers rather than tumor type.
  • Umbrella trials focus on a single tumor type but assess multiple drugs, matching patients to therapies targeting their specific biomarkers.
  • Platform trials evaluate multiple hypotheses within a single, adaptive protocol, allowing for modifications to drug dosage and sample size based on ongoing results.

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