December 9th 2024
The Phase III AALL1731 trial demonstrated that adding Blincyto (blinatumomab) to chemotherapy significantly improved three-year disease-free survival in pediatric patients with standard-risk B-cell acute lymphoblastic leukemia.
Phase II Piranga Trial Shows Promise of Xalnesiran Combination for Hepatitis B Treatment
Phase II Piranga trial found that the combination of xalnesiran and an immunomodulator effectively reduced hepatitis B surface antigen (HBsAg) levels, but highlighted challenges in response durability and efficacy in patients with high HBsAg levels.
Obe-Cel Achieves High Response Rates, Durable Outcomes in r/r B-Cell Acute Lymphoblastic Leukemia
CAR T-cell therapy obecabtagene autoleucel produced high response rates, durable outcomes, and low toxicity in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia, especially benefiting those with low-to-intermediate bone marrow burden.
Opdivo plus Yervoy Significantly Outperforms Chemotherapy in MSI-H/dMMR Metastatic Colorectal Cancer
Phase III CheckMate 8HW trial results demonstrated that the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improves progression-free survival and has a better safety profile compared to chemotherapy in the first-line treatment of MSI-H or dMMR metastatic colorectal cancer.
Truqap Combination Shines in Phase III Trial for Prostate Cancer
November 26th 2024Data from the CAPItello-281 trial show Truqap alongside abiraterone and androgen deprivation therapy achieved a statistically significant and clinically meaningful improvement in radiographic progression-free survival.
Empowering Sites and Patients: The Impact of Personalized Support in Clinical Trials
November 26th 2024To meet the growing demands of clinical research, sponsors must prioritize comprehensive support models, such as clinical site ambassadors and patient journey coordinators, who can address operational challenges and improve site relationships, patient satisfaction, and overall trial efficiency.
FDA Finalizes Decentralized Clinical Trial Guidance
November 25th 2024The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented populations and those in geographically or economically constrained areas.
Results from a followup evaluation of COLOFOL trial show no significant improvement in 10-year overall or colorectal cancer–specific mortality rates between high-frequency and low-frequency postoperative follow-up regimens for patients with stage II or III colorectal cancer.