October 17th 2024
In this video interview with ACT editor Andy, Studna, Silvio Galea, chief data & analytics officer, WCG, discusses the lack of awareness surrounding clinical research.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
Zepzelca Plus Tecentriq Significantly Improves Survival in Extensive-Stage Small Cell Lung Cancer
Preliminary data from the Phase III IMforte trial show the combination of Zepzelca (lurbinectedin) plus Tecentriq (atezolizumab) significantly improved overall survival and progression-free survival in patients with extensive-stage small cell lung cancer.
Data from the RAINBOWFISH trial shows early treatment with Evrysdi (risdiplam) in pre-symptomatic infants with spinal muscular atrophy (SMA) leads to significant motor milestone achievements, such as standing and walking, as well as cognitive development typical of non-SMA children, without the need for permanent ventilation.
Potential Challenges with FDA’s Multiregional Clinical Trials Guidance
October 14th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.
Tremfya Shows Superior Endoscopic Remission Rates in Crohn Disease, Ulcerative Colitis
Tremfya (guselkumab) demonstrated superior endoscopic remission rates in both Crohn disease and ulcerative colitis, including biologic-naïve and biologic-refractory patients, according to Phase III clinical trial data.
Ensuring Greater Access and Diverse Patient Populations
October 10th 2024In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.
Talzenna (talazoparib) with Xtandi (enzalutamide) produced a statistically significant improvement in overall survival among patients with metastatic castration-resistant prostate cancer, regardless of mutation status, making it the first combination of a PARP inhibitor and ARPI to achieve these results.
KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.