Clinical Trial News
Tagrisso Approved for EGFR-Mutated Lung Cancer in Combination with Chemotherapy
- The FDA approved AstraZeneca's Tagrisso with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
- Clinical trials showed the Tagrisso-chemo combination significantly reduced disease progression or death compared to Tagrisso alone.
- Tagrisso demonstrated statistically significant improvement in progression-free survival versus placebo post-chemoradiotherapy in unresectable Stage 3 NSCLC.
- The approval and trial data reinforce Tagrisso as a foundational therapy for EGFR-mutated lung cancer across different disease stages.
Cyclarity Therapeutics Advances in Developing a Plaque-Busting Molecule for Atherosclerosis
Cyclarity Therapeutics is making significant progress with its innovative small molecule drug, UDP-003, aimed at treating atherosclerosis by targeting oxidized cholesterol. With human clinical trials set to begin in Australia, the company is on the brink of potentially revolutionizing the treatment of cardiovascular diseases.
Next-Generation Clinical Data Management Systems Revolutionize Biotech Trials
- Advanced Electronic Data Capture (EDC) systems are transforming biotech trials through centralized data management, reducing errors and improving data quality across multiple sources.
- Decentralized trials and machine learning technologies are enabling broader patient participation while expediting study processes and enhancing real-world evidence collection.
- Integration of automation, natural language processing, and robust security protocols is reshaping clinical data management, leading to more efficient and secure biotechnology trials.
Double-Blind Trial Shows Comparable Efficacy in Treatment and Control Groups for Gastric Symptoms
A recent double-blind, non-inferiority, randomized controlled trial evaluated the efficacy of a treatment for various gastric symptoms, comparing it against a control group. The study found no statistically significant differences in clinical effective rates, symptom relief, and disappearance rates between the two groups, indicating comparable efficacy.
Global Study Links COVID-19 Vaccines to Rare Adverse Events
- A large global study identified rare but increased risks of specific neurological, blood, and heart-related conditions following COVID-19 vaccination.
- mRNA vaccines from Pfizer-BioNTech and Moderna were associated with a higher risk of heart inflammation.
- Viral-vector vaccines like AstraZeneca's showed an elevated risk of blood clots in the brain.
- The study affirms the importance of ongoing vaccine safety surveillance despite the overall benefits of COVID-19 vaccines.
Houtou Jianweiling Tablet Shows Promise in Treating Chronic Non-Atrophic Gastritis
A recent clinical trial has demonstrated the efficacy and safety of Houtou Jianweiling Tablet (HTJWT) in treating Chronic Non-Atrophic Gastritis (CNAG), offering a potential alternative to conventional treatments like Omeprazole. The study, conducted on Pakistani patients, found HTJWT to be non-inferior to Omeprazole in improving clinical symptoms of CNAG, with a good safety profile.
Highlighted Clinical Trials:
University of Karachi
Posted 11/8/2022
FDA Accepts Datopotamab Deruxtecan BLA for Nonsquamous NSCLC Treatment
- The FDA has accepted the Biologics License Application (BLA) for datopotamab deruxtecan for treating advanced nonsquamous non-small cell lung cancer (NSCLC).
- The BLA is based on the TROPION-Lung01 Phase III trial, which showed statistically significant improvement in progression-free survival (PFS) compared to docetaxel.
- Datopotamab deruxtecan is a TROP2-directed antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, potentially the first of its kind approved for NSCLC.
- The FDA's decision date is set for the fourth quarter of 2024, with ongoing regulatory discussions and submissions for breast cancer also underway.
FDA Approves Osimertinib Plus Chemo for EGFR-Mutated NSCLC
The FDA has approved the combination of osimertinib (Tagrisso) with platinum-based chemotherapy for treating patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has EGFR exon 19 deletions or exon 21 L858R mutations. This decision is based on the phase 3 FLAURA 2 study, which showed significant improvement in progression-free survival compared to osimertinib alone.
Highlighted Clinical Trials:
AstraZeneca
Posted 7/2/2019
NXC-201 CAR T-cell Therapy Shows Promise in AL Amyloidosis Despite Mortality Concerns
- NXC-201, a BCMA-directed CAR T-cell therapy, achieved a 100% hematologic response rate in heavily pretreated AL amyloidosis patients, with most responses occurring within one month.
- The CAR T-cell therapy demonstrated a favorable safety profile, with cytokine release syndrome generally mild (grades 1 and 2) in the treated patients.
- Despite the high hematologic response rate, a significant number of patients (6 out of 9) died during the study follow-up, raising concerns about long-term survival and disease progression.
- The study suggests NXC-201 could offer a potential one-time treatment for durable hematologic responses and improved organ responses in AL amyloidosis, warranting further investigation.
Denali and Sanofi's ALS Drug, SAR443820, Fails to Meet Primary Endpoint in Phase 2 Trial
- Denali Therapeutics and Sanofi's investigational drug SAR443820/DNL788 did not meet the primary endpoint in the Phase 2 HIMALAYA trial for amyotrophic lateral sclerosis (ALS).
- The primary endpoint was measured by change in the ALS Functional Rating Scale-Revised (ALSFRS-R), a tool used to assess the severity and progression of ALS.
- Sanofi plans to present detailed efficacy and safety results from the HIMALAYA study at an upcoming scientific forum, while continuing to evaluate SAR443820 in multiple sclerosis.
- This setback marks another challenge in the development of effective treatments for ALS, a neurodegenerative disease affecting thousands in the United States.
Highlighted Clinical Trials:
Sanofi
Posted 12/19/2022
Sanofi
Posted 11/25/2022
Sanofi
Posted 4/1/2021
Sanofi
Posted 4/13/2022