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Clinical Trial News

Targeted Therapies and Clinical Trials Transform Stage 4 EGFR Lung Cancer Treatment for Young Woman

  • A 35-year-old woman with stage 4 EGFR-mutated non-small cell lung cancer experienced tumor shrinkage and successful surgery due to targeted therapies and clinical trial options at MSK.
  • Molecular testing revealed an EGFR mutation, common in young, non-smoking women, guiding treatment decisions towards targeted therapies and clinical trials.
  • Treatment initially involved a clinical trial combining osimertinib with patritumab deruxtecan, later switched to osimertinib alone due to side effects, leading to tumor reduction and surgical removal.
  • Post-surgery, chemotherapy and continued osimertinib are being used to prevent recurrence after pathology revealed some cells were no longer responsive to EGFR drugs.

MIRASOL Trial Update: Mirvetuximab Soravtansine Shows Promise in Platinum-Resistant Ovarian Cancer

  • The Phase III MIRASOL trial evaluated mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer with high folate receptor-alpha (FRα) expression.
  • Mirvetuximab soravtansine demonstrated a statistically significant improvement in progression-free survival compared to chemotherapy in this patient population.
  • The study's findings suggest mirvetuximab soravtansine could become a valuable treatment option for patients with advanced ovarian cancer expressing high levels of FRα.
  • These results may lead to changes in the treatment paradigm for platinum-resistant ovarian cancer, offering a targeted therapy alternative to traditional chemotherapy.

Paxalisib, TTFields, and Proton Irradiation Show Promise in Neuro-oncology

• Paxalisib with radiation therapy showed intracranial responses in two-thirds of patients with PI3K-mutant brain metastases in a phase I study. • Tumor treating fields (TTFields) combined with standard therapy improved progression-free survival in newly diagnosed glioblastoma patients. • Proton craniospinal irradiation demonstrated encouraging overall survival in patients with leptomeningeal metastases, particularly those with breast and lung cancer.

Soylent Meal Replacement Improves Quality of Life in Head and Neck Cancer Patients Undergoing Chemoradiation

• A phase II study evaluated Soylent, a liquid meal replacement, in head and neck cancer patients undergoing chemoradiation to prevent malnutrition and maximize quality of life. • The study demonstrated high patient adherence to Soylent, with 94% of patients successfully transitioning to exclusive meal replacement after experiencing a 5% body weight loss. • The gastrostomy tube (G-tube) placement rate was low at 5%, indicating effective nutritional support with Soylent during cancer treatment. • Patient-reported quality of life, initially reduced during treatment, rebounded to exceed baseline levels within six months, suggesting long-term benefits of Soylent.

SEL-212 Demonstrates Improved Outcomes in Refractory Gout Patients

  • SEL-212, a novel two-component infusion therapy, significantly improved patient-reported outcomes in adults with refractory gout after three doses.
  • Further improvements in physical and mental health were observed with six doses of SEL-212, indicating a dose-dependent benefit for patients.
  • The DISSOLVE I and DISSOLVE II Phase 3 trials showed that SEL-212 enhances health-related quality of life, functional ability, and pain reduction.
  • These findings suggest SEL-212 could address the unmet needs of refractory gout patients who do not respond to conventional urate-lowering therapies.

Merck's Winrevair Shows Strong Efficacy in Severe Pulmonary Hypertension Trial

  • Merck's Winrevair, combined with background therapy, significantly improved outcomes in patients with severe pulmonary arterial hypertension (PAH).
  • The ZENITH trial was halted early due to Winrevair's overwhelming efficacy compared to placebo in reducing mortality and disease-related hospitalization.
  • Winrevair, acquired through the Acceleron acquisition, is projected to reach peak sales of $5 billion annually, driven by its impact on PAH treatment.
  • The drug's success in the ZENITH trial may broaden its application, pending further data and regulatory review.

Increased Water Intake Does Not Significantly Impact Health Outcomes: A Meta-Analysis of Randomized Trials

  • A meta-analysis of randomized controlled trials found that increased daily water intake did not significantly improve various health outcomes in adults.
  • The study included 12 trials with 1,758 participants, assessing effects on body weight, blood pressure, and other physiological measures.
  • Findings suggest that recommendations for increased water consumption may not be supported by robust clinical evidence for general health benefits.
  • Further research is needed to explore potential benefits in specific populations or for particular health conditions related to hydration.

HanX Biopharmaceuticals Eyes Hong Kong IPO to Advance Bispecific Antibody HX009

  • HanX Biopharmaceuticals is planning an IPO in Hong Kong to fund clinical trials for its lead drug candidate, HX009, a bispecific antibody targeting PD-1 and CD47.
  • HX009 is currently in early-phase studies for advanced melanoma and Epstein-Barr virus-linked lymphomas, with a phase 2 trial planned for biliary tract cancer.
  • HanX has received FDA approval to begin testing HX009 in the U.S. for diffuse large B-cell lymphoma, expanding its clinical reach.
  • The company's pipeline includes HX301 for glioblastoma and HX044 for PD-1 resistant tumors, supported by royalty income from Pucotenlimab.

IGC Pharma's IGC-AD1 Shows Cognitive Improvement in Phase 2 Alzheimer's Trial

  • IGC Pharma's IGC-AD1 demonstrated cognitive improvement in Alzheimer's patients in a Phase 2 trial, compared to placebo, over a six-week period.
  • The trial, primarily focused on agitation, revealed an average 8% improvement on the Mini-Mental State Examination (MMSE) in the active treatment group.
  • IGC-AD1 previously showed a reduction in amyloid plaque aggregation and improved spatial memory in preclinical studies, supporting its potential as a disease-modifying therapy.
  • The drug also offers rapid relief from agitation with a favorable safety profile, differentiating it from existing treatments that have slower onset and safety concerns.

Clinical Trial on Agitation in Alzheimer's Dementia

NCT05543681RecruitingPhase 2
IGC Pharma, LLC
Posted 10/11/2022

FDA Advised to Update Labels on GLP-1 Weight-Loss Drugs for Broader Applicability

  • Experts are advocating for the FDA to update labels on GLP-1 receptor agonists like liraglutide and semaglutide, and the GLP-1/GIP receptor agonist tirzepatide, to reflect cautious use in unstudied populations.
  • A cross-sectional study revealed that a significant portion of adults eligible for these weight-loss medications were excluded from initial clinical trials due to various health conditions.
  • The study highlights the need for greater understanding of trial generalizability, especially concerning individuals with major depressive disorder, malignant neoplasms, and other exclusion criteria.
  • The authors suggest that the FDA should advise caution in generalizing the safety and effectiveness of GLP-1 and GLP-1/GIP drugs to populations excluded from pivotal trials until further postmarketing studies are available.

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