Adoption of Amended Protocol for Ph 3 VERSATILE-003 Trial Incorporating PFS as Primary Endpoint for Interim Analysis and Potential Accelerated Approval Announced
“Including PFS as an interim primary endpoint provides a potential pathway to shorten the duration of VERSATILE-003 and accelerate the timeline to regulatory submission, as well as making the trial more cost efficient,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Survival and safety will continue to anchor full approval, and we remain confident in the path we’ve outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer.”
Share:
More News
“The designation reinforces the significant unmet need for effective treatment options for patients with advanced breast cancer,” said Charles Baum, M.D., Ph.D., Chief Executive Officer of Terremoto Biosciences. “We are committed to advancing highly selective therapies designed to expand treatment options for patients with difficult to treat cancers.”
“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two
Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: “The positive CHMP opinion for the sqNSCLC indication marks another important milestone in serplulimab’s regulatory journey in Europe and brings the product one step closer to achieving comprehensive coverage of first-line lung cancer treatment indications in the EU.