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Clinical Trial News

Fulzerasib Shows Promise in KRAS G12C-Mutated NSCLC: Updated Phase 2 Results

  • Fulzerasib demonstrated a confirmed objective response rate of 49.1% in patients with advanced NSCLC harboring the KRAS G12C mutation.
  • The disease control rate with fulzerasib was 90.5%, with a median progression-free survival of 9.7 months in the studied population.
  • Fulzerasib was generally well-tolerated, with most treatment-related adverse events being Grade 1-2 in severity, indicating a manageable safety profile.
  • Approved in China, fulzerasib offers a new treatment option for NSCLC patients with KRAS G12C mutations who have received prior systemic therapy.

A Study of GFH925 in Patients With Advanced Solid Tumors With KRAS G12C Mutations

NCT05005234RecruitingPhase 1
Innovent Biologics (Suzhou) Co. Ltd.
Posted 9/10/2021

Sacituzumab Govitecan Shows Promise in Second-Line Treatment of Extensive-Stage Small Cell Lung Cancer

  • Sacituzumab govitecan demonstrated a 41.9% overall response rate in patients with extensive-stage small cell lung cancer (ES-SCLC) who had progressed after one prior line of therapy.
  • The TROPiCS-03 trial data showed a manageable safety profile, consistent with previous studies of sacituzumab govitecan, with no treatment discontinuations due to adverse events.
  • Median overall survival was 13.6 months, and the median progression-free survival was 4.4 months, indicating a clinically meaningful benefit in this patient population.
  • These encouraging results have led to the initiation of a randomized phase 3 study to further evaluate sacituzumab govitecan in relapsed ES-SCLC.

Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors

NCT03964727Active, Not RecruitingPhase 2
Gilead Sciences
Posted 10/15/2019

Subcutaneous Daratumumab Improves Patient Experience in Multiple Myeloma Treatment

  • A multi-country study reveals that subcutaneous daratumumab is perceived more favorably than the intravenous form by multiple myeloma patients.
  • Patients reported reduced anxiety, stress, and fatigue with the subcutaneous formulation, alongside increased comfort and well-being during treatment.
  • The subcutaneous route significantly decreased hospital stay duration, allowing patients more time for daily activities and improving their quality of life.
  • The study highlights the importance of considering patient preferences in treatment administration for improved adherence and overall outcomes.

Oxford Scientists Develop First Cancer Prevention Vaccine for Lynch Syndrome Patients

  • University of Oxford researchers are developing LynchVax, a first-of-its-kind vaccine designed to prevent cancers in patients with Lynch syndrome, a genetic condition that increases cancer risk by 80%.
  • The vaccine aims to train the immune system to recognize and destroy pre-cancerous cells before they develop into bowel, womb, and ovarian cancers.
  • Lynch syndrome affects an estimated one in 400 people in England and causes approximately 1,100 bowel cancer cases annually, primarily in patients under 50.
  • Cancer Research UK has awarded the research team £550,000 to analyze pre-cancerous cells and determine which components can be targeted by the immune system.

Adaptive Deep Brain Stimulation Shows Promise in Parkinson's Disease

  • Adaptive deep brain stimulation (aDBS) significantly reduced the duration of bothersome symptoms in Parkinson's patients compared to conventional DBS.
  • Participants reported improved quality of life during aDBS sessions, with no significant adverse effects on mental health or sleep.
  • The aDBS system personalizes stimulation by measuring brain activity in real-time and adjusting stimulation levels accordingly.
  • Further research is needed to improve the accessibility and usability of aDBS systems for broader application in Parkinson's disease.

Real-World Evidence Shows Apixaban Reduces Major Bleeding Risk Compared to Rivaroxaban in Atrial Fibrillation Patients

Real World Evidence
  • Multiple large-scale real-world studies consistently demonstrate that apixaban is associated with 31-45% lower risk of major bleeding events compared to rivaroxaban in patients with non-valvular atrial fibrillation.
  • The COBRA-AF study, analyzing 177,866 propensity-matched patient pairs, found apixaban reduced the composite risk of major and clinically relevant non-major bleeding by 31% versus rivaroxaban.
  • Apixaban showed superior safety profiles across diverse patient populations, including those with chronic liver disease and bleeding history, while maintaining comparable stroke prevention efficacy.

Bevacizumab Addition to First-Line Chemotherapy Shows Real-World Benefit in High-Risk Ovarian Cancer

  • Real-world data confirms adding bevacizumab to first-line chemotherapy significantly extends time to next treatment in high-risk epithelial ovarian cancer patients from 11.7 to 13.6 months.
  • The study, published in Cancer, found a trend toward improved overall survival (31.1 vs 27.4 months) when bevacizumab was added to chemotherapy in patients with stage IV disease or stage III with visible residual disease.
  • Researchers analyzed 1,752 patients with stage III/IV epithelial ovarian cancer, concluding bevacizumab's benefits are specifically limited to those with defined high-risk prognostic factors.

Phanes Therapeutics Doses First Patient in PT886 Combination Trials for Advanced Cancers

  • Phanes Therapeutics has dosed the first patient in a clinical study evaluating PT886 combined with chemotherapy for pancreatic and gastric cancers.
  • The TWINPEAK Phase I/II trial (NCT05482893) assesses PT886's safety, tolerability, pharmacokinetics, and preliminary efficacy in advanced solid tumors.
  • PT886, a first-in-class bispecific antibody, targets claudin 18.2 and CD47, and has received FDA Orphan Drug and Fast Track designations for pancreatic cancer.
  • A separate cohort in the TWINPEAK study is evaluating PT886 in combination with pembrolizumab for gastric and gastroesophageal junction cancers.

Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or ICI, for the Treatment of Patients With Advanced Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)

NCT05482893RecruitingPhase 1
Phanes Therapeutics
Posted 3/15/2023

Paxlovid's Efficacy Questioned in Lower-Risk COVID-19 Patients

  • A recent randomized clinical trial found that Paxlovid did not significantly reduce the duration of COVID-19 symptoms in lower-risk adults compared to placebo.
  • The study population consisted mainly of individuals under 65 with prior SARS-CoV-2 immunity and mild to moderate symptoms during the Delta and early Omicron variant periods.
  • Secondary analyses suggested a potential reduction in severe disease outcomes within a higher-risk subset, aligning with previous Paxlovid studies.
  • Experts suggest Paxlovid is unlikely to improve acute symptomatic disease outcomes for younger, healthy adults with prior vaccination or infection.

MediciNova's Ibudilast (MN-166) Shows Promise in COMBAT-ALS Trial: Interim Analysis to be Presented at International Symposium

  • MediciNova's MN-166 (ibudilast) abstract, detailing the COMBAT-ALS trial for ALS treatment, has been accepted for a poster presentation.
  • The presentation will feature an update and interim analysis results from the Phase 2b/3 COMBAT-ALS trial of MN-166 (Ibudilast) in ALS.
  • MN-166 (ibudilast) is a small molecule compound targeting PDE4 and inflammatory cytokines, currently in late-stage development for neurodegenerative diseases.
  • The poster will be presented by the trial's lead Principal Investigator, Björn Oskarsson, at the 35th International Symposium on ALS/MND in Montreal.

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