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Clinical Trial News

KEYFORM-007 Trial: Favezelimab/Pembrolizumab Combo Fails in MSS mCRC

  • The Phase 3 KEYFORM-007 trial evaluating favezelimab and pembrolizumab combination did not meet its primary endpoint of overall survival (OS).
  • The trial focused on patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
  • The safety profile of the fixed-dose combination was consistent with previous studies, with no new safety signals observed.
  • Merck plans to share the full data with the scientific community and continue exploring new treatment options for colorectal cancer.

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)

NCT05508867Active, Not RecruitingPhase 2
Merck Sharp & Dohme LLC
Posted 10/18/2022

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

NCT05064059CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 11/10/2021

Rocatinlimab Shows Promise in Phase 3 Trial for Moderate to Severe Atopic Dermatitis

  • Rocatinlimab met co-primary endpoints in the Phase 3 ROCKET HORIZON trial, demonstrating significant improvement in skin clearance for atopic dermatitis patients.
  • The trial achieved a statistically significant reduction in Eczema Area and Severity Index (EASI-75) scores compared to placebo at week 24.
  • Key secondary endpoints, including itch reduction and improved quality of life, also showed statistically significant improvements with rocatinlimab.
  • Safety findings in the ROCKET HORIZON trial were consistent with those observed in the Phase 2b study, supporting the drug's tolerability.

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

NCT05651711CompletedPhase 3
Amgen
Posted 12/14/2022

Novo Nordisk Faces Senate Scrutiny Over Ozempic and Wegovy Pricing

  • Novo Nordisk CEO Lars Fruergaard Jørgensen testified before the Senate regarding the high prices of Ozempic and Wegovy in the U.S.
  • A federal appeals court revived PhRMA's challenge to the Inflation Reduction Act (IRA), which will impact drug price negotiations.
  • Bristol Myers Squibb's KarXT awaits FDA decision as a potential first-in-class treatment for schizophrenia.
  • Novo Nordisk's oral cannabinoid receptor 1 drug showed promising weight loss results in a Phase IIa trial, but with reported adverse events.

Adaptive Sample Size Recalculation in Three-Stage Clinical Trials Explored

  • Researchers have investigated sample size recalculation in three-stage clinical trials, focusing on normally distributed endpoints with a common variance.
  • The study uses a two-sample t-test statistic at each stage to test the alternative hypothesis against the null hypothesis, maintaining the type I error rate.
  • Conditional power, the probability to reject the null hypothesis given observed interim results, is used to decide on the number of patients to recruit after interim analysis.
  • The research compares group sequential designs with designs allowing sample size recalculation, examining the impact of first-stage sample size on trial benefits.

Amgen's Uplizna Shows Promise in Myasthenia Gravis Trial, Rocatinlimab Data Disappoints

  • Amgen's Uplizna met its primary endpoint in a Phase 3 trial for generalized myasthenia gravis (gMG), demonstrating statistically significant improvement in daily living activities.
  • The MINT trial for Uplizna included both AChR+ and MuSK+ patients, showing clinically meaningful changes in MG-ADL and QMG scores compared to placebo.
  • Rocatinlimab, Amgen's experimental drug for atopic dermatitis, showed statistically significant improvement versus placebo, but analysts expressed concerns about its efficacy profile.
  • Amgen plans to file for approval of Uplizna in the U.S. for gMG, while continuing to study rocatinlimab in eczema, asthma, and prurigo nodularis.

Myasthenia Gravis Inebilizumab Trial

NCT04524273Active, Not RecruitingPhase 3
Amgen
Posted 10/15/2020

FDA Approves First Over-the-Counter Continuous Glucose Monitor, Stelo

• The FDA has approved Stelo, the first over-the-counter continuous glucose monitor (CGM) for adults with diabetes who do not use insulin. • Stelo, a small sensor paired with a smartphone app, allows users to track and understand their blood sugar levels without fingersticks. • While enhancing accessibility, Stelo's high cost may limit its adoption, prompting calls for cost reduction strategies by healthcare advocates. • Experts suggest Stelo could be a preventative tool for individuals with prediabetes or undiagnosed diabetes, though caution is advised against misinterpreting glucose values.

Genespire Secures $52 Million to Advance Gene Therapy for Methylmalonic Acidemia

  • Genespire has raised $52 million in a Series B financing round to advance its gene therapy program for Methylmalonic Acidemia (MMA).
  • The funding will support the development of GENE202, an off-the-shelf gene therapy, through a Phase I/II clinical trial.
  • Genespire's Immune Shielded Lentiviral Vector (ISLV) platform delivers the therapy directly to the liver for lifelong production.
  • The financing will also bolster the company's pipeline of gene therapies targeting other genetic diseases.

Modified Bone Marrow Transplant Strategy Boosts Anti-Cancer Effect and Reduces Immune Complications

  • A clinical trial explored a modified bone marrow transplant strategy to reduce graft-versus-host disease risks in patients with hematologic malignancies.
  • The approach involves removing only naïve T cells, preserving mature memory T cells to maintain a robust immune system and anti-cancer effect.
  • Adding natural killer cells to the treatment further enhances the anti-cancer effects by targeting cells that evade T cell responses.
  • Results showed a low risk of relapse and improved outcomes, especially for patients with relapsed or refractory disease.

Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy

NCT01807611CompletedPhase 2
St. Jude Children's Research Hospital
Posted 5/16/2013

Experimental Nasal Spray PCANS Shows Promise Against Broad Range of Respiratory Viruses

  • A novel, non-drug nasal spray, Pathogen Capture and Neutralizing Spray (PCANS), has been developed to trap and neutralize respiratory viruses in the nose.
  • PCANS demonstrated the ability to capture twice as many respiratory droplets as natural mucus in lab tests using a 3D-printed human nose replica.
  • In mice, a single dose of PCANS provided complete protection against a lethal dose of influenza virus, preventing lung infection and inflammation.
  • The spray, composed of FDA-approved ingredients, neutralized nearly 100% of tested viruses and bacteria, including influenza, SARS-CoV-2, and RSV.

Mayo Clinic Expert Outlines Future of Pharmacogenomics and Precision Medicine in Oncology Care

  • Mayo Clinic's approach distinguishes between pharmacogenomics for optimizing drug dosing and precision medicine for targeting specific tumor drivers, with dedicated specialists supporting both areas.
  • The future of pharmacy practice will shift toward more patient-facing roles and comprehensive medication management, supported by automation and AI for routine tasks.
  • A predicted surge in cellular therapies and complex cancer treatments will require enhanced collaboration between pharmacists, advanced practice nurses, and physicians to manage increasing patient loads.

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