Clinical Trial News
FDA Grants Breakthrough Therapy Designation to Adaptimmune's T-Cell Therapy for Synovial Sarcoma
- The FDA granted Breakthrough Therapy designation to Adaptimmune's affinity-enhanced T-cell therapy targeting NY-ESO for synovial sarcoma, expediting its development.
- The designation was based on Phase I/II trial results showing a 60% response rate in patients receiving the target dose of engineered T-cells.
- Adaptimmune's therapy targets HLA-A201, HLA-A205, or HLA-A*206 allele-positive patients with inoperable or metastatic synovial sarcoma.
- The company plans to initiate pivotal studies with the NY-ESO-targeting T-cell therapy around year-end 2016, exploring its potential in other cancers.
Tetanus Shot Enhances Survival in Brain Tumor Immunotherapy
A study led by Duke Cancer Institute researchers reveals that a tetanus booster significantly improves the effectiveness of a vaccine therapy for glioblastoma, a lethal brain tumor, by enhancing the immune system's response. This innovative approach has shown to dramatically increase patient survival rates, with half of the treated patients living nearly five years or longer.
Study Evaluates Intra-arterial Tenecteplase Following Endovascular Therapy for Acute Stroke
A new clinical trial, ATTENTION-IA, is investigating the efficacy and safety of intra-arterial tenecteplase after successful endovascular therapy (EVT) in patients with acute posterior circulation large or medium vessel occlusion. The trial aims to improve outcomes for stroke patients by addressing persistent distal hypoperfusion and microcirculatory obstruction, common issues even after successful EVT.
Highlighted Clinical Trials:
The First Affiliated Hospital of University of Science and Technology of China
Posted 1/24/2023
Phase 1b Trial of Dostarlimab Combinations Shows Promise in Advanced Solid Tumors
A phase 1b clinical trial, IOLite, evaluated the safety and efficacy of dostarlimab in combination with niraparib or carboplatin–paclitaxel, with or without bevacizumab, in patients with advanced solid tumors. The study found these combinations to be safe and tolerable, with promising antitumor activity. The trial established recommended phase 2 doses for each combination and observed no new safety signals. Tumor response rates were encouraging, particularly in combinations involving bevacizumab, suggesting potential for further investigation in larger, randomized phase 3 studies.
Highlighted Clinical Trials:
Tesaro, Inc.
Posted 10/12/2017
Tesaro, Inc.
Posted 4/15/2016
FDA Approves Three Novel Therapies for Relapsed Multiple Myeloma
- The FDA approved daratumumab (Darzalex) as a monotherapy for multiple myeloma patients who have undergone at least three prior treatments.
- Ixazomib (Ninlaro), a proteasome inhibitor, was approved for relapsed multiple myeloma patients after one prior treatment, showing improved progression-free survival.
- Elotuzumab (Empliciti) received approval for patients with one to three prior therapies, demonstrating extended progression-free survival when combined with lenalidomide and dexamethasone.
The Reporting of Adverse Events in Oncology Phase III Trials
A study comparing the current status of adverse events (AEs) reporting in oncology phase III trials with the expectations of the European Organization for Research and Treatment of Cancer (EORTC) membership reveals significant discrepancies. While most reports include grade 3/4 AEs, there's a lack of comprehensive reporting on grade 5 AEs, AEs leading to study withdrawal, and dose reduction, contrary to EORTC members' expectations.
FDA Approves Record 45 New Drugs in 2015, Led by Breakthrough Cancer Immunotherapy Opdivo
- The FDA approved 45 new drugs in 2015, marking a significant rise in R&D productivity, with Bristol-Myers Squibb's immunotherapy Opdivo leading the pack with five new indications for various cancers.
- Novel treatments like Vertex's Orkambi for cystic fibrosis and Novartis's Entresto for heart failure demonstrated remarkable clinical innovation, though pricing concerns remained central to industry discussions.
- The year saw major developments in drug pricing debates, with the emergence of ICER as an independent US cost-effectiveness watchdog and increased scrutiny of pharmaceutical pricing practices.
Sanofi and Boehringer Ingelheim Announce €11.4B Asset Swap Deal to Reshape Consumer Health Market
- Sanofi will acquire Boehringer Ingelheim's consumer health division valued at €6.7B, while divesting its animal health business Merial for €11.4B, positioning Sanofi as the global leader in consumer healthcare.
- The strategic exchange includes a €4.7B cash payment to Sanofi from Boehringer Ingelheim, with the combined deal expected to create a consumer health business generating approximately €5.1B in annual revenue.
- The asset swap, set to close in Q4 2016, maintains workforce stability with minimal redundancies planned, requiring regulatory approval and union consultation before completion.
Novel Cancer Drug Development Pipeline Shows Promise Across Multiple Therapeutic Areas
- Recent advances in oncology drug development have shown significant progress across multiple cancer types, with several promising candidates entering late-stage clinical trials.
- Pharmaceutical companies are increasingly focusing on targeted therapies and precision medicine approaches, leading to more personalized treatment options for cancer patients.
- New drug development strategies are addressing previously challenging cancer targets, with improved efficacy and safety profiles compared to conventional treatments.
The BWEL Trial: A Study on Weight Loss and Breast Cancer Recurrence
The Breast Cancer Weight Loss (BWEL) trial investigates the impact of weight loss on reducing cancer recurrence in overweight or obese women with stage II-III breast cancer. This randomized, controlled trial compares a telephone-based weight loss intervention plus health education materials against health education materials alone, aiming for a ≥10% weight loss through increased physical activity and caloric restriction.
Highlighted Clinical Trials:
Alliance for Clinical Trials in Oncology
Posted 9/16/2016