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Clinical Trial News

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.

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

• The FDA has approved Roche's PATHWAY HER2 (4B5) test for biliary tract cancer (BTC) to identify patients eligible for Jazz Pharmaceuticals' ZIIHERA (zanidatamab-hrii). • This marks the first FDA-approved companion diagnostic for HER2-positive BTC, addressing a critical gap in treatment options for this aggressive cancer. • The PATHWAY HER2 test standardizes immunohistochemistry processes, ensuring reliable results for therapeutic decisions and minimizing variability. • ZIIHERA is the first FDA-approved therapy for previously treated, unresectable or metastatic HER2-positive biliary tract cancer.

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.

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

• Roche's PATHWAY HER2 (4B5) test gains FDA approval as a companion diagnostic for identifying biliary tract cancer (BTC) patients eligible for ZIIHERA treatment. • The approval addresses a critical need for standardized HER2 testing in BTC, where treatment options are limited and prognosis is generally poor. • This expansion significantly broadens the clinical utility of the PATHWAY HER2 (4B5) test, offering a new avenue for personalized medicine in BTC. • ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer.

Advancements in ALS Research, AI-Driven Drug Discovery, and Single-Cell Protein Profiling Highlighted

  • Answer ALS and Cedars-Sinai have completed a large ALS patient-based stem cell and bio data repository, offering researchers unprecedented access to biological and clinical data.
  • Healx will use Sanofi compound data with its Healnet AI platform to identify new disease indications, leveraging AI to find connections for novel treatments.
  • Scale Biosciences and Revvity’s BioLegend have launched TotalSeq Phenocyte, a single-cell protein profiling solution for identifying and characterizing rare cell subtypes.
  • BioNTech acquired Biotheus, obtaining full rights to BNT327/PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, enhancing its oncology strategy.

FDA Approves Attruby (Acoramidis) for ATTR-CM, Showing Near-Complete TTR Stabilization

• The FDA has approved Attruby (acoramidis) for treating adults with ATTR-CM, aiming to reduce cardiovascular death and related hospitalizations. • Attruby is the first and only approved product with a label specifying near-complete stabilization (≥90%) of Transthyretin (TTR). • Clinical trials demonstrated Attruby's rapid benefit, with a 42% reduction in combined all-cause mortality and recurrent cardiovascular hospitalization events at 30 months. • BridgeBio will provide Attruby free for life to U.S. clinical trial participants and offers patient support services through ForgingBridges™.

Alkannin Shows Promise in Esophageal Cancer Treatment by Targeting GSK3β

  • Alkannin, a natural compound, significantly inhibits esophageal squamous cell carcinoma (ESCC) cell proliferation in vitro and in vivo.
  • The compound induces G2/M phase cell cycle arrest and apoptosis in ESCC cells by suppressing GSK3β expression.
  • Transcriptomic analysis identifies GSK3β as a key target in Alkannin's anti-ESCC effects, suggesting a novel therapeutic strategy.
  • In vivo studies demonstrate that Alkannin effectively inhibits the growth of ESCC xenograft tumors in mice, supporting its potential as a cancer drug.

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