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Clinical Trial News

Nasal Polyposis: Emerging Therapies and Clinical Trial Updates

• Several companies are actively developing novel therapies for nasal polyposis, showing promising advancements in treatment options. • Key players like GlaxoSmithKline, Sanofi, Regeneron, and AstraZeneca are progressing with therapies such as Fasenra, Tezepelumab and Dupixent. • Phase 3 trial data for Tezspire (tezepelumab-ekko) demonstrated a significant reduction in nasal polyp size and nasal congestion. • Biologics targeting inflammatory pathways are emerging as promising therapies for refractory cases of nasal polyposis.

Advancements in Clinical Trials for Fabry Disease, C. difficile Infections, and Mydriasis

• Clinical trials are actively progressing for Fabry Disease, with companies like Idorsia and Sanofi Genzyme developing novel therapies. • Emerging treatments like Venglustat and Pegunigalsidase alfa are expected to significantly impact the Fabry Disease market in the coming years. • Research and development efforts are also focused on Clostridium Difficile Infections, with Vedanta Biosciences leading Phase 3 trials for VE303. • Mydriasis treatments are advancing, with companies like Eyenovia exploring solutions like MYDCOMBI for pupil dilation.

Rising Lung Cancer Rates Among Young Adults Prompt Shift to Precision Oncology Approaches

  • Alarming increase in lung cancer cases among young adults and non-smokers signals a significant shift in disease demographics and risk factors.
  • Envita Medical Center implements advanced precision oncology model utilizing thousands of biomarkers to develop personalized treatment plans for improved patient outcomes.
  • Environmental exposures and infections emerge as crucial risk factors, highlighting the need for expanded early screening protocols beyond traditional smoking-related criteria.

FDA Approves Roche's PATHWAY HER2 Test as Companion Diagnostic for Biliary Tract Cancer

• The FDA has approved Roche's PATHWAY HER2 (4B5) test as a companion diagnostic for identifying biliary tract cancer (BTC) patients eligible for ZIIHERA treatment. • This approval marks the first validated HER2 test for BTC, offering a standardized method to determine eligibility for HER2-targeted therapies. • ZIIHERA is the first FDA-approved treatment for previously treated, unresectable, or metastatic HER2-positive biliary tract cancer, addressing a critical unmet need. • The PATHWAY HER2 (4B5) test expands its clinical utility, now aiding in personalized medicine for BTC patients who may benefit from targeted therapy.

Eflornithine Plus Lomustine Improves Survival in IDH-Mutant Grade 3 Astrocytoma

  • The STELLAR trial showed that eflornithine combined with lomustine significantly improved overall survival in recurrent grade 3 IDH-mutant astrocytoma patients.
  • Median overall survival increased to 34.9 months with the combination therapy, compared to 23.5 months with lomustine alone.
  • Progression-free survival also saw a significant boost, with a median of 15.8 months in the combination arm versus 7.2 months in the lomustine arm.
  • The combination therapy was generally well-tolerated, with a safety profile consistent with previous studies, offering a potential new treatment option.

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

NCT02796261Unknown StatusPhase 3
Orbus Therapeutics, Inc.
Posted 7/1/2016

AZD1390 to be Evaluated in GBM AGILE Trial for Newly Diagnosed Glioblastoma

  • AstraZeneca's AZD1390, a brain-penetrant ATM kinase inhibitor, will be evaluated in the GBM AGILE trial for newly diagnosed glioblastoma patients.
  • GBM AGILE is an adaptive platform trial designed to expedite the identification of effective therapies for glioblastoma, an aggressive brain cancer.
  • AZD1390 has shown encouraging preliminary efficacy in recurrent glioblastoma and potential as a radiosensitizer in earlier studies.
  • Patient recruitment for the AZD1390 arm of the GBM AGILE trial is expected to commence by Q2 2025.

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

NCT03970447RecruitingPhase 2
Global Coalition for Adaptive Research
Posted 7/30/2019

Novartis' Scemblix Shows Sustained Efficacy in Chronic Myeloid Leukemia at 96 Weeks

  • Scemblix (asciminib) demonstrates favorable safety and tolerability compared to investigator-selected tyrosine kinase inhibitors in newly diagnosed chronic myeloid leukemia.
  • Interim results from the Phase 2 ASC2ESCALATE trial show efficacy and safety of asciminib in CML patients after one prior tyrosine kinase inhibitor.
  • The Phase 3 ASC4OPT study indicates high efficacy and favorable tolerability of asciminib at different dosages in CML patients previously treated with multiple TKIs.

Novartis Highlights Scemblix and Kisqali Data at ASH and SABCS

• Scemblix demonstrated favorable safety and tolerability in newly diagnosed chronic myeloid leukemia patients in the ASC4FIRST Phase III study. • Kisqali showed promising distant disease-free survival across key subgroups in HR+/HER2- early breast cancer from the Phase III NATALEE trial. • Novartis is presenting over 65 abstracts at ASH and SABCS, showcasing advancements in hematologic diseases and cancers.

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