First pancreatic cancer patient in global Ph 3 registrational trial, MAPKeeper 301, to be dosed in mid-2026
“We are very pleased with our interactions with both the FDA and EMA, which we believe speaks to the compelling data we have generated to date in first-line pancreatic cancer, as well as the strength and simplicity of our proposed Phase 3 trial for atebimetinib,” said Ben Zeskind, Ph.D., Co-Founder and Chief Executive Officer of Immuneering. “Importantly, the regulators’ feedback supports our trial design and key primary endpoint of overall survival, and we are confident that our team is well-positioned to begin dosing patients in this global registrational trial in mid-2026. We are also thrilled to expand the planned trial to 510 patients, which gives more first-line pancreatic cancer patients the opportunity to participate, and further increases statistical robustness. In addition, we are excited to provide an update on overall survival in the Phase 2a trial in the coming weeks.”
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.