Discussions around updated OS data from Aegean Trial
Discussions around updated OS data from Aegean Trial
Amol Akhade shared a post on X:
“Updated OS data from Aegean Trial. After censoring for deaths due to covid 19 – HR for OS is 0.85 ( CI – 0.64 to 1.12 ).
Note that FDA has suggested in its own document that even if OS is demonstrated, it will not show contribution of Neoadjuvant component vs Adjuvant component separately. FDA has suggested new designs for future perioperative trials.
ODAC votes on July 25th on these questions.”
Bishal Gyawali shared Amol Akhade’s post on X, adding:
“Indeed, these are important questions. We should not subject patients to 1 year of therapeutic burden without any evidence that it adds any benefit beyond the neoadjuvant treatment. We have raised this issue in our Nature Reviews Clinical Oncology comment.”
Howard Jack West, Vice President of Clinical Development at Summit Therapeutics, Inc., shared a post on X:
“Riddle me this, Batman: why was contribution of phase not a prohibitive issue with approval of pembro based on the KEYNOTE-671 trial but is now a critical factor for other trials with same design for same setting?”
Vamsi Velcheti, Professor of Medicine at New York University, shared Howard Jack West’s post on X, adding:
“FDA’s emphasis on distinguishing neoadjuvant vs. adjuvant contributions in AEGEAN trials ensures precise efficacy data and optimizes patient safety. Though KEYNOTE-671 with a similar design was approved earlier evolving standards underscore necessity for phase specific clarity.
This design approach should have been the standard with these periop trials from beginning to ensure comprehensive evaluation of therapeutic impact. Balancing rigorous scientific evaluation with patients centered care remains paramount.”
Bishal Gyawali, MD, PhD, is a medical oncologist from Nepal. Currently an Associate Professor at Queen’s University, Kingston, Canada, and affiliated with Brigham and Women’s Hospital, Boston, USA, he is involved in global oncology initiatives.
Dr. Gyawali serves on several committees, including the WHO Essential Medicines List Cancer Medicines Working Group and ASCO’s Health Equity and Outcomes Committee, contributing significantly to cancer policy and evidence-based oncology.
Amol Akhade is a senior consultant medical oncologist and hemato-oncologist. He has received his super specialization training in hemato-oncology and medical oncology from Tata Memorial Hospital. He specialises in chemotherapy for hematological cancers as well as solid tumors.
He also specialises in allogenic and autologous bone marrow transplant. Currently, he is a Consultant Medical Oncologist at Suyog Cancer Clinics and Reliance Hospitals.
