Davy James

Editorial Director at Applied Clinical Trials

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Articles

Phase III MATTERHORN Trial Shows Imfinzi Combo Significantly Improves Event-Free Survival in Resectable Gastric and GEJ Cancers

4 days ago | appliedclinicaltrialsonline.com | Davy James

First Immunotherapy to Achieve Statistically Significant EFS in Resectable Gastric and GEJ Cancers. Imfinzi (durvalumab) combined with FLOT chemotherapy significantly improved event-free survival (EFS) versus chemotherapy alone in resectable Stage II–IVA gastric and gastroesophageal junction (GEJ) cancers, becoming the first immunotherapy to reach this milestone in a global Phase III trial. Durable Two-Year EFS and Strong Trend Toward OS Benefit.
Phase III BREAKWATER Trial Shows Braftovi-Based Regimen Improves Survival in BRAF V600E-Mutant Metastatic Colorectal Cancer

5 days ago | appliedclinicaltrialsonline.com | Davy James

First-Line Survival Milestone in BRAF V600E mCRCThe Braftovi (encorafenib) combination regimen is the first to show a statistically significant and clinically meaningful overall survival benefit in treatment-naïve patients with BRAF V600E-mutant metastatic colorectal cancer, doubling median OS to 30.3 months.
ARCHES and ENZAMET Trials Confirm Long-Term Xtandi Efficacy in Metastatic Hormone-Sensitive Prostate Cancer

2 weeks ago | appliedclinicaltrialsonline.com | Davy James

May 23, 2025Five- and eight-year trial data to be presented at ASCO demonstrate durable survival outcomes with Xtandi (enzalutamide) plus ADT, reinforcing its role as a frontline standard in metastatic hormone-sensitive prostate cancer. Long-Term Survival Confirmed.
Nerandomilast Meets Primary Endpoints in Phase III IPF and PPF Trials, Shows Significant Lung Function Preservation

2 weeks ago | appliedclinicaltrialsonline.com | Davy James

Nerandomilast Demonstrates Statistically Significant FVC Preservation in IPF and PPFIn both the FIBRONEER-IPF and FIBRONEER-ILD Phase III trials, nerandomilast achieved the primary endpoint by significantly reducing the decline in forced vital capacity (FVC) over 52 weeks, compared to placebo—supporting its role in slowing disease progression in idiopathic and progressive pulmonary fibrosis.
FDA Panel Votes Against Columvi-GemOx sBLA for R/R DLBCL Over Regional Data Concerns from STARGLO Trial

2 weeks ago | appliedclinicaltrialsonline.com | Davy James

FDA Panel Votes Against Columvi-GemOx sBLAThe FDA’s Oncologic Drugs Advisory Committee (ODAC) declined to recommend approval of Columvi (glofitamab) plus GemOx for relapsed/refractory (R/R) DLBCL in patients ineligible for stem cell transplant, citing limited applicability of STARGLO trial data to the US population. STARGLO Trial Shows Significant Survival BenefitThe Phase III STARGLO trial demonstrated a 41% reduction in risk of death and doubled median overall survival (25.5 vs.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma

2 weeks ago | appliedclinicaltrialsonline.com | Davy James

Airsupra Reduces Severe Exacerbations by 47%In the Phase IIIb BATURA trial, Airsupra (albuterol/budesonide) significantly lowered the risk of severe asthma exacerbations in patients with mild disease compared to albuterol monotherapy (HR 0.53; p<0.001). Lower Systemic Steroid ExposurePatients receiving Airsupra had a 63% reduction in mean annualized systemic corticosteroid use, addressing a major concern in long-term asthma management.
Merck and Daiichi Sankyo Launch Global Phase III Trial of Novel Antibody Drug Conjugate in Advanced Esophageal Squamous Cell Carcinoma

2 weeks ago | appliedclinicaltrialsonline.com | Davy James

Phase III IDeate-Esophageal01 Trial LaunchesMerck and Daiichi Sankyo have initiated a global, multicenter Phase III trial evaluating ifinatamab deruxtecan (I-DXd) in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) previously treated with platinum-based chemotherapy and immune checkpoint inhibitors. I-DXd Targets B7-H3 in Solid TumorsThe investigational antibody-drug conjugate (ADC) I-DXd is designed to target B7-H3, a protein overexpressed in various tumors.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity

3 weeks ago | appliedclinicaltrialsonline.com | Davy James

Clinically Meaningful Efficacy: In the Phase II TAK-861-2001 trial, oveporexton significantly improved average sleep latency, reduced daytime sleepiness, and decreased cataplexy frequency in patients with narcolepsy type 1 (NT1), with effects exceeding those of currently approved therapies.
KEYNOTE-B96 Trial Shows Keytruda is First Immunotherapy to Improve Overall Survival in Platinum-Resistant Ovarian Cancer

3 weeks ago | appliedclinicaltrialsonline.com | Davy James

Keytruda Shows First OS Benefit in Ovarian Cancer: The KEYNOTE-B96 trial marks the first time an immune checkpoint inhibitor—Keytruda (pembrolizumab)—has demonstrated a statistically significant improvement in overall survival (OS) in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1. Significant PFS and OS Improvements with Keytruda-Based Regimen.
iTeos and GSK Halt TIGIT Antibody Belrestotug Development After Phase II Trials Miss Efficacy Marks in NSCLC and HNSCC

3 weeks ago | appliedclinicaltrialsonline.com | Davy James

🧬 Belrestotug Development HaltediTeos and GSK have ended all development of the TIGIT-targeting antibody belrestotug after interim Phase II data failed to meet efficacy goals in NSCLC and HNSCC trials. 📉 Efficacy Below ThresholdsThe combination of belrestotug and Jemperli did not demonstrate meaningful improvements in progression-free survival or objective response rate compared to Jemperli alone.

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Davy James

Articles

Phase III MATTERHORN Trial Shows Imfinzi Combo Significantly Improves Event-Free Survival in Resectable Gastric and GEJ Cancers

Phase III BREAKWATER Trial Shows Braftovi-Based Regimen Improves Survival in BRAF V600E-Mutant Metastatic Colorectal Cancer

ARCHES and ENZAMET Trials Confirm Long-Term Xtandi Efficacy in Metastatic Hormone-Sensitive Prostate Cancer

Nerandomilast Meets Primary Endpoints in Phase III IPF and PPF Trials, Shows Significant Lung Function Preservation

FDA Panel Votes Against Columvi-GemOx sBLA for R/R DLBCL Over Regional Data Concerns from STARGLO Trial

Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma

Merck and Daiichi Sankyo Launch Global Phase III Trial of Novel Antibody Drug Conjugate in Advanced Esophageal Squamous Cell Carcinoma

Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity

KEYNOTE-B96 Trial Shows Keytruda is First Immunotherapy to Improve Overall Survival in Platinum-Resistant Ovarian Cancer

iTeos and GSK Halt TIGIT Antibody Belrestotug Development After Phase II Trials Miss Efficacy Marks in NSCLC and HNSCC

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